A mixed methods assessment of implementation of fluoride-citrate tubes for pregnancy oral glucose tolerance tests: glucose stabilisation improves identification of Aboriginal women requiring pharmaceutical intervention for gestational diabetes

A mixed methods assessment of implementation of fluoride-citrate tubes for pregnancy oral glucose tolerance tests: glucose stabilisation improves identification of Aboriginal women requiring pharmaceutical intervention for gestational diabetes | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article A mixed methods assessment of implementation of fluoride-citrate tubes for pregnancy oral glucose tolerance tests: glucose stabilisation improves identification of Aboriginal women requiring pharmaceutical intervention for gestational diabetes Erica P Spry, Emma L Jamieson, Lorraine Anderson, Mark A Hoey, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7316550/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 7 You are reading this latest preprint version Abstract Background An estimated 62% of gestational diabetes mellitus (GDM) in rural and remote Australia are missed due to preanalytical error in measuring glucose for the oral glucose tolerance test (OGTT). To address diagnostic inequity, Kimberley Aboriginal Community Control Health Organisations (ACCHOs) replaced fluoride-oxalate (FLOX) tubes with fluoride-citrate (FC) tubes that better preserve glucose in all pregnancy OGTTs in 2019. This study describes FC tube implementation and impact on GDM detection and management. Methods A mixed methods approach was used. Acceptability, barriers, enablers and resources required to support implementation were assessed using qualitative descriptive approaches. These were mapped to the Dynamic Sustainability Framework domains of practice settings and ecological systems. A retrospective audit of antenatal records for women attending a Kimberley ACCHO (2018–2021) described maternal characteristics, OGTT (≥ 24-weeks’ gestation), GDM management, and birth outcomes over 24-months pre- (T1) and post- (T2) FC tube implementation. Outcomes using new Australian 2025 diagnostic criteria were compared to 2014 criteria (T2 only). Results Clinicians’ initial concerns (increased GDM diagnosis, interventions at birth, low resources) were resolved when they became more confident in FC glucose measurements. The main barriers to implementation were staff turnover, pathology testing systems and supply chain issues. Of 830 eligible women, 378 (45.5%) completed an OGTT within the audit periods: 196 T1 (FLOX); 182 T2 (FC). Glucose at all OGTT time-points was 0.7 to 0.8 mmol/L higher in T2 (v T1). The 2.8-fold increase in GDM with FC tubes was largely due to increased diagnoses at the fasting sample (39.3% v 78.1% of GDM cases, P = 0.001). Seven-fold more women were recommended for pharmaceutical management of hyperglycaemia (2.6% T1 v 17.6% T2, P < 0.001). Neonatal growth-for-gestational-age and induction of labour was similar between T1 and T2. Using new higher OGTT cut-points would reduce GDM diagnoses (27.5% v 40.1%, P < 0.001), while identifying 84.4% of women requiring pharmaceutical management. Conclusions Collection of blood into FC tubes improved identification of women requiring pharmaceutical intervention for GDM. There was no adverse impact on birth interventions. A collective approach involving healthcare practices and pathology providers to implement diagnostic strategies that improve OGTT accuracy is urgently required. Aboriginal health Gestational Diabetes Mellitus (GDM) Implementation diabetes in pregnancy diagnosis glucose preanalytics OGTT fluoride-citrate tube Figures Figure 1 Contributions to the literature Research has shown that testing for gestational diabetes (high blood glucose levels in pregnancy) is impacted by sample handling before measurement. In rural and remote Australia up to 2 in 3 women with gestational diabetes are missed due to this sample instability. We found that implementing new sample collection tubes containing fluoride-citrate in remote Australian settings improved sample stability. While there were some barriers to implementation, they were overcome through engagement with clinicians and pathology providers and refinement of ordering processes. These findings will inform Australian jurisdictions considering implementing fluoride-citrate tubes when adopting new 2025 diagnostic criteria. Background There is clear evidence for a continuous linear association between maternal glycaemia and adverse pregnancy outcomes.( 1 , 2 ) Management of gestational diabetes mellitus (GDM), or hyperglycaemia first detected in pregnancy, can improve pregnancy outcomes.( 3 , 4 ) Universal screening for GDM, generally with a one-step oral glucose tolerance test (OGTT), is recommended for all pregnant women without known diabetes.( 5 ) Repeat testing to confirm GDM is not recommended as it would delay initiation of management.( 6 ) Therefore, accurate glucose measurement is paramount to reduce diagnostic errors.( 7 , 8 ) Pre-analytical instability of glucose in OGTT samples is a significant, yet often underappreciated factor that can impact detection of GDM.( 9 ) Most jurisdictions in Australia rely on fluoride, a latent glycolytic inhibitor, in fluoride-oxalate (FLOX) tubes to stabilise glucose in OGTT samples. However, delays in processing FLOX samples can result in significant in vitro glycolysis,( 10 , 11 ) leading to between 40% and 62% missed GDM diagnoses of those tested with current criteria.( 12 ) Inherently long distances to transport specimens for laboratory analysis for most women living in rural and remote locations exacerbates this diagnostic error. In the Optimisation of Rural Clinical and Haematological Indicators for Diabetes in pregnancy (ORCHID) study the median delay to laboratory processing of samples was 5-hours (2.3- to 124-hours) from collection of the first fasting OGTT specimen.( 11 ) Delays were worse in remote clinics, including those in the Kimberley region of Western Australia, where 25% of OGTT samples arrived at the laboratory more than 24-hours post collection. In these settings, the maximum in vitro loss of glucose impacted specimens all three OGTT timepoints.( 11 ) This variation in diagnostic processes due to geographical disadvantage leads to diagnostic inequity for women with GDM.( 13 ) Improving OGTT sample stability will become even more imperative in rural and remote Australia when new elevated diagnostic criteria for GDM are implemented.( 14 ) Collection tubes with a combination of fluoride and citrate buffer (FC) have been recommended for use for pregnancy OGTT in other countries for the past three to 14 years: Croatia (2010), the United States of America (2011), Germany (2014), Sweden (2015), Austria and Switzerland (2018), and Norway (2021).( 15 – 18 ) Citrate acidifies the sample which immediately stabilises plasma glucose without requirement for prompt plasma separation or storage in ice.( 19 ) The simplified pre-analytical process makes FC tubes a pragmatic solution for low-resource settings and rural and remote centres.( 20 ) However, concerns have been raised about potential overdiagnosis of GDM following reports of up to 0.37 mmol/L bias in glucose measures from FC tubes compared to rapid centrifugation.( 12 ) In the ORCHID cohort, FC tubes were estimated to improve both GDM detection and identification of pregnancies at risk of macrosomia when compared to FLOX tubes.( 21 ) To improve pregnancy outcomes, the Kimberley Lead Clinicians Forum endorsed FC tubes for all pregnancy OGTT performed in Kimberley Aboriginal Community Controlled Health Organisations (ACCHOs) in September 2019. To date, Kimberley ACCHOs are the only healthcare providers in Australia to formally implement FC tubes.( 20 ) To better embed the FC tubes into routine clinical practice, Kimberley ACCHOs needed to understand factors important in ‘real world’ utilisation and implementation, such as clinical support required, and clinic and laboratory staff acceptability. This paper assessed FC tube implementation processes and outcomes in Kimberley ACCHOs using modified domains of the Dynamic Sustainability Framework (DSF).( 22 ) We interpreted the DSF domains to refer to FC tube implementation as the intervention; the regional clinic systems and training as the practice setting; and pathology laboratories, supply chain and general Australian context as the ecological system. Assessment included a retrospective evaluation of GDM detection and management, and potential impact of proposed new cut-points. Methods This study used a mixed methods approach to explore implementation outcomes using the DSF.( 22 ) This framework facilitates examination of how the intervention, and practice and ecological settings enable or inhibit FC tube implementation into routine clinical practice, while accounting for changes over time. This study aligns to the Consolidated criteria for strengthening reporting of health research involving Indigenous peoples (CONSIDER),( 23 ) and Standards for Reporting Implementation Studies (StaRI),( 24 ) and our statements against these standards are available (Supplementary Files 1 and 2). Governance and Indigenous Data Sovereignty Aboriginal culture, family and community are central to the ORCHID Study. Aboriginal Community Boards and Investigators provide Aboriginal leadership and oversight. This study, which is integrated within the major health service providers in regional, rural and remote WA, uses existing governance structures (e.g., regional Aboriginal health planning forums). It includes Aboriginal people, clinicians, administrators and policy makers as core members of the research team. Participating Aboriginal communities and ACCHOs are equal partners in the analysis, interpretation and publication of project data. They have provided letters of support and research collaborative agreements, which are updated to account for new phases of the project. Agreement details include: Aboriginal community and ACCHO involvement in the ORCHID Study, including monitoring the research. Copyright and intellectual property management; a key part of the governance arrangement is adherence to the principals of Indigenous Data Sovereignty.( 25 ) Project data and research findings belong to Aboriginal communities and ACCHOs. Expectations of the ORCHID team (e.g., regular reports to be provided, permission to publish and disseminate project findings to be sought), and the resources we will provide. Kimberley ACCHOs (Kimberley Aboriginal Medical Services, Broome Regional Aboriginal Medical Service, Derby Aboriginal Health Service, Ord Valley Aboriginal Health Service, and Yura Yungi Medical Service) requested support from the ORCHID Study for the implementation and evaluation of FC tube usage. Therefore, for the audit there was a more informal approach between participating ACCHOs and the ORCHID team. This included an understanding that the project would adhere to the conditions set out in the research agreements. As the project was a retrospective clinical audit that aimed to identify areas for quality improvement collective consent was granted by each Kimberley ACCHO. They also provided approval for ORCHID team members to access their patients’ electronic medical records (MMEx, 2024 ISA Healthcare Solutions) and Stork Perinatal Dataset Discharge Summaries. Confidentiality was a key consideration in the audit. Bulk data exports were imported into Research Electronic Database Capture (REDCap). Personal identifiers were only used to link the results of tests, reports and procedures for the same person from different locations. For manually entered data (e.g. GDM management) the medical record identifier was recorded for each patient to enable linking of batch exported data (e.g., weight, height). Results were reported on de-identified data only. Positionality ES is a Bardi Jawi traditional owner, a mother of four and experienced GDM with her third child. ES is employed in a joint research position through KAMS and the Rural Clinical School of Western Australia and is based in Broome. She joined the ORCHID Study in 2016 as an Aboriginal Research Officer and is currently a Senior Aboriginal Research Officer (KAMS) and Research Fellow (The University of Western Australia). She co-leads this and another diabetes project. EJ has been involved in diabetes research projects for 23 years. For the past 10 years she coordinated the ORCHID study from rural Western Australia and completed her PhD on optimising screening for GDM. This included evaluating and reporting on underdiagnosis of GDM due to preanalytical glycolysis in rural and remote WA. LA traces her Aboriginal heritage to the Palawa people of Tasmania. She has many years’ experience as a lead clinician in rural and remote Western Australia and rural New Zealand. She is the Medical Director of the KAMS (from 2019), chairs the Kimberley ACCHO Lead Clinicians Forum, and supported implementation of FC tubes into routine clinical practice across Kimberley ACCHOs. MH is a junior doctor who has worked in rural Western Australia for the past two years, including in antenatal care in the Great Southern region. He was involved with data collection and analysis for the retrospective audit (rural research student MD project). As part of his capacity building, he presented his project findings to the Kimberley ACCHO Lead Clinicians Forum. AK is a rural General Practitioner Obstetrician with 18 years' experience in antenatal care, including a significant number of pregnant women diagnosed with GDM. He is completing a PhD on barriers and enablers of GDM screening in regional, rural and remote WA. JM is based in Broome and has been conducting collaborative health services research, predominately with Kimberley ACCHOs, over the past 19 years. She led the development of the ORCHID Study. ES, EJ and JM regularly provide individual support and clinic level in-services to clinicians participating in the ORCHID Study. ES led this FC tube implementation project, supported by the other two ORCHID Study co-leads (JM, EJ). Research Design The quantitative component descriptively analysed a retrospective audit of ACCHO electronic medical records to explore impact of FC tube use on GDM incidence and management. The data are reflective of two time periods: Time period 1 (T1) captures the 24-months prior to FC tube implementation (01/09/2017–31/08/2019); Time period 2 (T2) captures the 24-months post-FC tube implementation (01/10/2019–30/09/2021). Rates of screening using the OGTT at 24–28 weeks gestation were also assessed during each time period. Acceptability,( 26 , 27 ) barriers and enablers, and resources required to support implementation were assessed using qualitative descriptive approaches.( 28 ) From the start of the implementation process, ES [Aboriginal researcher] kept detailed notes on all contact with relevant stakeholders. ES and EJ provided support for ordering FC tubes, including tracking arrival and expiry dates. ORCHID Study newsletters and papers were also shared with stakeholders and ES provided friendly reminders for clinicians to use FC tubes for all pregnancy OGTTs. Clinic staff concerns were noted and followed up. All details of stakeholder contact including meeting minutes, brief reflections, and processes of developing the ORCHID Study FC tube policy guidelines were recorded by ES in the KAMS ‘Plan Do Study Act (PDSA) and Action Plan document’ stored on their Quality Management System (Logiqc). ORCHID co-leads (ES, EJ, JM) stored all relevant emails with ACCHOs, laboratory staff and suppliers. Clinician comments about FC tubes from another ORCHID sub-study ( 29 ) were noted. Regional Setting The Kimberley region of Western Australia (WA) covers 423,517 square kilometres and consists of 274 remote and very remote communities (Modified Monash Model remoteness category 6–7).( 30 , 31 ) In 2021, 41.1% of the Kimberley population (14,408) identified as Aboriginal and/or Torres Strait Islander people.( 32 ) A total of 3,371 births were recorded for Kimberley women between 2017 and 2021 inclusive.( 33 ) Antenatal care for Kimberley Aboriginal women is generally shared between the Western Australian Country Health Services (WACHS) and ACCHOs.( 29 ) KAMS is a member based, regional ACCHO that supports and represents the interests of eight independent Kimberley ACCHOs (member services). KAMS also delivers culturally appropriate primary health care services to five remote Aboriginal Communities. Clinical Setting Endorsed by the Kimberley Aboriginal Health Planning Forum (KAHPF), Kimberley Clinical Guidelines aim to standardise the screening and management of prevalent health conditions in the Kimberley. Hence, regional guidelines can differ from state or national guidelines. The KAHPF Diabetes in Pregnancy Clinical Guideline (2017), which included Australasian Diabetes in Pregnancy Society (ADIPS) 2014 screening and diagnostic recommendations, was in use throughout the audit (Table 1 ).( 34 ) Table 1 Summary of Kimberley Aboriginal Health Planning Forum Clinical Guideline for Diabetes in Pregnancy (2017) Screening • An OGTT as early in pregnancy as practicable for women with risk-factors for diabetes • An OGTT between 24- and 28-weeks’ gestation for all pregnant women without known diabetes • GDM defined as one or more OGTT values equal to or above thresholds: FPG 5.1 mmol/L, 1h-PG 10.0 mmol/L, 2h-PG 8.5 mmol/L Management • Initiation of metformin for women with GDM based on elevated self-monitoring of blood glucose levels: o Fasting: ≥5.1 mmol/L once or more in a week o Two-hour post-prandial: ≥6.7 mmol/L twice or more in a week • Metformin dosage: 500 mg daily, increasing weekly as required with 2000 mg daily as maximum dose • Initiation of insulin alongside metformin when blood glucose targets were not achieved with metformin alone Mode and timing of delivery • No indication for pre-term induction for women not on insulin or metformin and with no evidence of macrosomia, polyhydramnios or intra-uterine growth restriction • Arrange an elective birth between 38- and 40-weeks gestation for women on insulin or metformin to prevent stillbirth without increasing neonatal morbidity OGTT = oral glucose tolerance test, FPG = fasting plasma glucose, PG = plasma glucose, GDM = gestational diabetes To optimise sample collection, most pregnancy OGTTs were performed in Kimberley ACCHO and WACHS remote clinics, rather than dedicated pathology collection centres. The standard OGTT pre-analytical protocol at all sites was for storage of samples at room temperature before batch transportation to laboratory for analysis. Prior to FC tube implementation, FLOX tubes were used for all pregnancy OGTT collections (BD: Vacutainer Fluoride Tube, 367921, 2 mL) with exception for some ORCHID Study participants. ORCHID Phase One (FLOX tubes) involved six Kimberley ACCHOs from 2015–2018 and included a small, paired sample study (FLOX v FC tubes; N = 6) conducted at one Kimberley ACCHO.( 11 ) ORCHID Phase Two (FC tubes) involved two Kimberley ACCHOs from 2020–2022. Eleven Kimberley clinics implemented FC tubes for all pregnancy OGTTs in September 2019 (nine ACCHO clinics, and three remote WACHS antenatal clinics; Greiner Bio-One: Vacuette FC Mix Tube 454511, 2mL). The primary focus of this paper is to describe the implementation in Kimberley ACCHOs. At the time of implementation, only two manufacturers in the world produced FC tubes, and only Greiner Bio-One produced tubes with a granular mixture, which avoided the need for a dilution factor correction for glucose values in FC tubes that had the glucose preservative as a liquid additive.( 12 ) Neither tube type was stocked in Australia. No post-analytical correction of glucose measures from FC tubes was applied. Data analysis Retrospective audit Records were audited for 1074 pregnant women who attended a Kimberley ACCHO for antenatal care within the T1 and T2 audit periods (Fig. 1 ). Records were excluded for women requiring early pregnancy management for hyperglycaemia (< 24-weeks’ gestation), including pre-existing diabetes, miscarriage and termination of pregnancy, or delivery prior to 24-weeks’ gestation. Records included for data analysis were for women with a pregnancy OGTT collection (≥ 24-weeks’ gestation) within the audit time periods. Women without OGTT data were assigned to an audit period based on the date at 28 + 6 -weeks’ gestation. The OGTT was considered complete if a pathology report with plasma glucose at all three OGTT timepoints was present in the electronic medical record or linked to My Health record (Australian national electronic health record system). In the absence of a pathology report, the OGTT was marked as complete if it was documented in the progress notes (using search term ‘GTT’); uploaded antenatal documents (manual search); or correspondence with shared care providers (manual search). Records with incomplete OGTT or OGTT not collected into FLOX tubes in T1 nor FC tubes in T2, based on pathology report or site of collection, were excluded from analysis (Fig. 1 ). Risk factors for GDM,( 34 ) OGTT results, GDM management and birth outcome data were collected and managed using secure REDCap electronic data capture tools hosted at The University of WA.( 35 ) GDM diagnosis was defined by ADIPS 2014 criteria (vide supra).( 36 ) In a separate analysis, new ADIPS 2025 criteria (fasting PG ≥ 5.3 mmol/L, 1h-PG ≥ 10.6 mmol/L, 2h-PG ≥ 9.0 mmol/L) were applied retrospectively to the T2 period only.( 14 ) GDM diagnosis and identification of women requiring insulin or metformin in the T2 period (FC tubes and ADIPS 2025 criteria) were compared with the T1 period (FLOX tubes and ADIPS 2014 criteria). Adverse birth outcomes were defined by Hyperglycaemia and Adverse Pregnancy Outcomes (HAPO) study definition,( 1 ) noting modification to calculation of newborn birthweight centile. Birthweight centiles were calculated using Global bulk centile calculator, Gestation Related Optimal Weight (GROW) v8.0.6.1,( 37 ) adjusting for gestational age, maternal height, maternal weight at first antenatal visit, parity, ethnicity and infant sex. Adjustment for maternal weight made within BMI limits of 18.5–30 kg/m 2 only. Large-for-gestational-age (LGA) and small-for-gestational-age (SGA) newborn were defined as birthweight greater than 90th centile and less than the 10th centile, respectively. All analyses were performed with Stata version 18 (Statacorp). Differences in characteristics between the T1 and T2 periods were compared using t-tests for continuous data and Pearson χ 2 tests for categorical data. P < 0.05 was defined as statistically significant. Qualitative Relevant information was extracted from previous qualitative interviews with eight clinicians regarding challenges and enablers of GDM screening.( 29 ) As previously described,( 29 ) AK conducted semi-structured interviews with clinicians who delivered antenatal care in regional, rural and remote WA. These data were professionally transcribed, coded and analysed using directed qualitative content analysis.( 29 ) Any content that referred to FC tube use by Kimberley interviewees was re-analysed (JM, ES, EJ). The initial focus of the review of individual documents (e.g., interview transcripts, PDSA, emails) was to identify factors that facilitated or were barriers to implementing FC tubes over time (2019–2021). This included acceptability of using FC tubes in routine clinical practise and FC tube supply issues. These data were mapped to the modified DFS domains of practice setting and ecological systems. Results In early 2019, data analysis from a small ORCHID Study paired-sample cohort showed the efficacy of FC tubes in preventing glycolysis compared to usual Kimberley practice for OGTT collections (Table 2 , Preanalytical process). Findings were immediately communicated with the KAMS Medical Director who provided initial endorsement for adoption of FC tubes. FC tubes were formally endorsed for use in all pregnancy OGTTs collected by Kimberley ACCHOs following presentation of findings at the Kimberley ACCHO Lead Clinicians Forum. Endorsement was conditional on the ORCHID team providing the initial batch of FC tubes and auditing the impact of implementation. After obtaining support from all relevant stakeholders (Table 3 ), FC tube implementation centred on the following DFS domains: 1) practice settings (supporting clinics and clinicians), and 2) ecological systems (pathology testing, supply chain and Australian context) (Table 2 ). Table 2 Overview of Implementation of the fluoride-citrate (FC) tubes using the Dynamic Sustainability framework (DSF)( 22 ) Intervention Theme Issue Action / Solution Outcome (as of Dec 2024) Preanalytical process: OGTT collection tube type • Sub-optimal preanalytical process for OGTT leading to missed diagnoses of GDM and missed pregnancies with large-for-gestational age newborn • Presented findings to Kimberley Lead Clinicians Forum (LCF) 12th March 2019 and 29th August 2019 • Excess Greiner Bio One FC Tubes from ORCHID Study offered for use for OGTT • Kimberley LCF approved FC tube use for all pregnancy OGTTs in Kimberley ACCHO and WACHS clinics serviced by KAMS clinicians (Sep 2019) Laboratory process • FLOX tubes only accepted by local pathology providers • Laboratory information system (LIS) did not recognise FC tubes as a tube type • Presented findings to Statewide public pathology service • Discussed logistics with Kimberley Statewide public pathology service laboratory managers • FC tube stamp made to record tube type on pathology request form to track tube usage • FC tube approved for glucose measures by Statewide public pathology service Special Biochemistry department, with FC tubes to be run on auto analyser as FLOX tube type • Clinics needed to supply FC tubes • Unresolved: FC tubes still recorded as FLOX on LIS Impact on GDM incidence • Concerns regarding impact of change of tube type on GDM incidence • Kimberley LCF requested ORCHID Study team audit implementation • Regular contact between ORCHID Study team and Kimberley clinicians to address any concerns raised (see Table 2 ) • Head of Department, WACHS Obstetrics and Gynaecology – Kimberley consulted to help guide interpretation of borderline OGTT results • Audit findings regularly communicated back to LCF • 2.7-fold increase in GDM T2 v T1 • 6.0-fold increase in pharmaceutical use for women diagnosed with GDM • Over diagnosis concerns addressed: e.g. reassured by evaluation of abnormal glycated haemoglobin at first presentation • Induction concerns addressed: consultation with Midwife & Obstetrician “comfortable” with inducing women without pharmaceutical intervention at 40-weeks gestation Practice setting (context) Theme Issue Action / Solution Outcome (as of Dec 2024) Clinic systems and training • No regional policy for using FC tubes • Lack of Kimberley clinician knowledge of impact of glycolysis on glucose measures • High turnover of clinical staff • Clinician role responsible for OGTT collection varied between clinics • Increased tube inversion requirements: manufacturer instructions are to invert FC tubes ten times immediately post collection versus eight to ten times for FLOX tubes • Aboriginal researcher (ES), KAMS management and remote support staff developed a policy document for KAMS • Policy document endorsed by all the other Kimberley ACCHOs and added to KAMS induction for remote clinicians • Developed practical resources: implementation support letter, brochure, clinic poster, FC Mix stamp for Statewide public pathology service request form, educational video by Aboriginal researcher (ES) • Identified management and clinic staff to champion change • Directory of contacts for support staff and trained staff • KAMS PDSA & Action Plan • Policy document used by all Kimberley ACCHOs • Audit of request forms from first month post implementation showed all OGTTs conducted used FC tubes • Clinicians could access tubes as required Logistics: clinics • Statewide public pathology service normally provides collection tubes but stipulated that clinics will need to provide FC tubes • Transparent tube labels difficult to read • KAMS clinicians service two Remote Area Clinics under WACHS • Consulted KAMS store and estimated the number of pregnancy OGTT each year per clinic, developed tube distribution list and established internal ordering system • Provided self-adhesive labels for clinics without label printer • Updated process for KAMS stores to supply FC tubes to WACHS Remote Area Clinics via visiting KAMS clinicians • ACCHO & WACHS Remote Area Clinics received the appropriate number of FC tubes • 12-month supply of FC tubes to a WACHS town clinic • KAMS store added reordering of FC tubes to their internal order form Ecological System Theme Issue Action / Solution Outcome (as of Dec 2023) Pathology laboratory • Locum staff unawareness of local Kimberley policy led to rejection of FC tubes at point of receipt • Clinic staff advised ORCHID study who liaised with pathology provider • Consulted with Statewide public pathology service local and regional laboratory managers and Special Biochemistry Department • Memorandum sent to all Statewide public pathology service staff to accept FC tubes for remote sites from Clinical Biochemistry Scientist in Charge • Improvement of locum staff awareness of use of tubes for OGTT in Kimberley region • Added to Statewide public pathology service Test Directory as an Alternative Container 3rd April 2024 Supply chain • FC tubes not stocked in Australia and the Kimberley region was the only Australian location using FC tubes for routine clinical practice, since 2019. • Tube expiry 12-months from manufacture – delays due to shipping reduced shelf life on receipt (range 201 to 311 days) • Distributor challenges with ordering from international manufacturer • Market forces: COVID-19 increased shipping delays and impacted on resources e.g., citrate, reduced availability of tubes. This led to gaps between batch lot expiry and arrival of new batch • Annual minimum order 3-months before batch lot expiry • Delivery via airfreight (versus shipping container) • ORCHID study provided excess tubes to KAMS • Development of recommendations for alternate strategies to minimise glycolysis to cover gap in FC tube availability – emailed to Kimberley ACCHOs • Minimum order size of 1200 tubes led to unnecessary high cost and waste (~ 50%) • Temporary return to use of FLOX tubes in 2022 (three months delay) Alignment with national guidelines • ADIPS – no specification for OGTT preanalytical process in 2014 guideline update following endorsement of HAPO criteria • Members of the ORCHID Study team joined RCPA & AACB Preanalytical Glucose Working Group • Advocated for endorsement of FC tubes for use Australia wide, including presentations at state, national and international conferences • Increased awareness of the impact of glycolysis on OGTT results • Review article by members of Preanalytical Glucose Working Group recommends FC tubes for remote locations • Under Review: ADIPS to include specification to address glycolysis AACB = Australasian Association of Clinical Biochemistry and Laboratory Medicine; ACCHO = Aboriginal Community Controlled Health Organisation; ADIPS = Australasian Diabetes in Pregnancy Society; FLOX = fluoride oxalate; KAMS = Kimberley Aboriginal Medical Services; PDSA = Plan Do Study Act; OGTT = oral glucose tolerance test; ORCHID = Optimisation of screening and management of diabetes in pregnancy study; RCPA = Royal College of Pathologists Australasia; WACHS = Western Australian Table 3 ORCHID Study team stakeholder engagement before, during and after implementation of FC tubes Engagement Type Who Forums / group sessions • Kimberley Lead Clinicians Forum every 3–6 months • KAHPF Kimberley Maternal and Child Health Workshops and Forums • KAMS Board • KAMS Remote Services Team • ACCHO clinic in-services Email / phone call (individual basis) • Midwives, at first use and ad hoc to address issues • Stores, at order and receipt • Clinics, ad hoc including at order and receipt and stocktake • Pathology, ad hoc to address issues • Distributor, at order and receipt KAHPF = Kimberley Aboriginal Health Planning Forum; KAMS = Kimberley Aboriginal Medical Service; ACCHO = Aboriginal Community Controlled Health Organisation Practice setting: Supporting clinics and clinicians To support sustainable implementation, we developed a PDSA Plan as per KAMS continuous quality improvement processes. This included creating a new policy document, resources and providing inductions for new KAMS remote clinicians (Table 2 , Clinic systems and training). The ORCHID team provided prompt responses to clinicians regarding use of FC tubes and concerns regarding a perceived GDM over-diagnosis (Table 2 , Impact on GDM incidence). Initial concerns included increased burden of managing GDM for women and clinics, associated lack of resources (e.g., patient blood glucose meters) and potential for increased interventions at birth (e.g., induced labour). How many have we got on the books now, like 55 I think, there’s 10 diabetics. … Well, that’s what I’m saying. Because I rang her [ORCHID Co-Lead] and said, “Are you sure we’re not over diagnosing?” And she goes, “Well, look at the profiles”, and they’re all up. (Midwife) Regular updates were provided to all stakeholders via newsletters, in-services, webinars and plain language statements for ORCHID study publications, with links provided to all documents on the KAMS website (Table 2 , Impact on GDM incidence). Over time, clinicians became more confident in the glucose measurements using FC tubes. Because when we were doing the ORCHID study and we were using the different tubes [FLOX] to the ones that we currently use, there were women who I would put money on would have had GDM who then did a negative test, but later on had a macrocosmic baby or other things, and you’re like, “No, I’m sure she should have had GDM.” I must admit I feel that a lot less now that we’re using the different tubes [FC]. There were women we were [not] picking up who I highly suspect had GDM and we’re picking them up now. So, I have a lot more confidence in the test now than I did before. (General Practitioner Obstetrician) Clinicians reported the need for specific recommendations for interpretation of borderline results from FLOX or FC tubes and the importance for interpretation of results as part of a complete clinical picture, including self-blood glucose monitoring profiles. Just to write down something generally about the fluoride citrate tubes with the range and to how to interpret such an accurate tube, rather than old one [FLOX]. (Midwife) Impact of the Intervention Of 829 records audited as eligible for OGTT ≥ 24-weeks’ gestation, 379 had complete OGTT results on file and were included for analysis (Fig. 1 ). Another 53 women who had attempted an OGTT but were excluded (11 no recorded glucose measures, 12 disparate tube type, 30 incomplete, Fig. 1 ). The remaining 397 (47.9%) with no record of attempting an OGTT were included for comparison as the ‘No OGTT’ group. Other than propensity to overweight (29.3% v 20.7%, P = 0.007) there were no statistically significant differences in baseline maternal characteristics between women who did and did not attempt an OGTT at or after 24-weeks’ gestation (data not shown). There were also no statistically significant differences in baseline maternal characteristics for women with complete OGTT data in the T1 versus T2 period (Table 4 ). Table 4 Maternal characteristics of women stratified by OGTT completion in the T1 or T2 periods Ɨ Maternal characteristics No OGTT (T1 & T2) N = 397 T1 (FLOX) N = 195 T2 (FC) N = 184 P-value (T1 v T2) Age (years) 25 ± 6 25 ± 6 26 ± 6 0.374 Aboriginal and/or Torres Strait Islander 384 (96.7%) 186 (95.4%) 175 (95.1%) 0.900 Booking body mass index (BMI, kg/m 2 ) ǂ 25.3 ± 6.5 26.4 ± 6.0 26.9 ± 6.5 0.452 Booking BMI category ǂ Underweight (< 18.5) 51 (13.4%) 18 (9.2%) 11 (6.0%) Healthy weight (18.5 to < 25.0) 154 (40.4%) 69 (35.4%) 71 (38.6%) Overweight (25.0 to < 30.0) 79 (20.7%) 58 (29.7%) 53 (28.8%) Obese (≥ 30.0) 97 (25.5%) 50 (25.6%) 49 (26.6%) 0.651 Parity (prior delivery ≥ 20-weeks) ≥ 1 § 240 (67.0%) 126 (66.0%) 109 (61.6%) 0.381 Previous GDM 19 (4.8%) 8 (4.1%) 10 (5.4%) 0.542 Family history of diabetes ¶ 76 (19.1%) 42 (21.5%) 43 (23.4%) 0.669 Any antenatal smoking 137 (34.5%) 56 (28.7%) 59 (32.1%) 0.479 OGTT = 75 g oral glucose tolerance test; FLOX = fluoride-oxalate tube; FC = fluoride-citrate tube. Ɨ T1 time period before implementation of FC tubes (OGTT collection between 01/09/2017 and 31/08/2019); T2 time period after implementation of FC tubes (OGTT collection between 01/10/2019 and 30/09/2021). Women designated No OGTT (no evidence of OGTT completion nor attempt) were assigned to the T1 or T2 period based on the date at 28 + 6 -weeks gestation. ǂ Booking BMI is maternal weight in kilograms measured at booking antenatal visit divided by the square of maternal height in metres. BMI data only available for 381 (No OGTT) antenatal records. § Parity data only available for 343 (No OGTT), 191 (T1), and 177 (T2) antenatal records. ¶ Family history of diabetes includes women with a first-degree relative with type 1 or type 2 diabetes or history of GDM. Data includes 776 women who attended for antenatal care at a Kimberley Aboriginal Community Controlled Health Organisation; 397 with no evidence of OGTT completion nor attempt and 379 with complete OGTT at or after 24-weeks gestation in the T1 or T2 period. Data are mean ± standard deviation for continuous variables and number and proportion (%) of T1 or T2 cohort for categorical variables. Two-sided t-test P -value reported for comparison between T1 and T2 groups for continuous data and Pearson chi-square test P -value reported for comparison between T1 and T2 groups for categorical data. Women in each time period tended to have their OGTT at 28-weeks’ gestation (Table 5 ). As expected, mean plasma glucose at all three OGTT time-points was 0.7 to 0.8 mmol/L higher in the T2 period compared to the T1 period (Table 5 ). Using ADIPS 2014 criteria there was a 2.8-fold increase in GDM diagnoses with FC tubes compared to FLOX tubes. This difference was largely due to increased detection at the fasting sample (78.1% v 39.3% of GDM cases, P = 0.001). Using ADIPS 2025 criteria for T2 (FC tubes), the GDM diagnosis would only increase 1.9-fold compared to T1 (FLOX tubes). Table 5 OGTT and management outcomes for women using ADIPS-2014 (T1 and T2) and ADIPS-2025 (T2 Ɨ ) cut-points OGTT T1 Ɨ (FLOX ADIPS 2014) N = 195 T2 Ɨ (FC ADIPS 2014) N = 184 P -value T1 Ɨ v T2 Ɨ (ADIPS 2014) T2 Ɨ (FC ADIPS 2025) N = 184 P -value T1 Ɨ v T2 Ɨ (FC ADIPS 2025) Gestational age at OGTT (weeks) 28.3 ± 2.0 28.2 ± 2.7 0.537 FPG (mmol/L) 4.2 ± 0.5 4.9 ± 0.8 < 0.001 1h-PG (mmol/L) 7.3 ± 1.6 8.1 ± 2.1 < 0.001 2h-PG (mmol/L) 6.1 ± 1.4 6.9 ± 2.3 < 0.001 Number above diagnostic threshold at each sample: FPG 11 (5.6%) 57 (31.0%) < 0.001 36 (19.6%) < 0.001 1h-PG 16 (8.2%) 29 (15.8%) 0.023 19 (10.3%) 0.476 2h-PG 14 (7.2%) 26 (14.1%) 0.028 22 (12.0%) 0.113 Cumulative number diagnosed with GDM: At FPG sample 11 (5.6%) 57 (31.0%) 36 (19.6%) At FPG & 1h-PG sample 25 (12.8%) 69 (37.5%) 44 (23.9%) At FPG, 1h- and 2h-PG sample 28 (14.4%) 73 (39.7%) 0.001 50 (27.2%) < 0.001 Antenatal management of hyperglycaemia No GDM: standard antenatal care ǂ 167 (85.6%) 109 (59.2%) 134 (72.8%) GDM: no management recorded 5 (2.6%) 3 (1.6%) 2 (1.1%) GDM: non-pharmacological intervention § 18 (9.2%) 39 (21.2%) 20 (10.8%) GDM: pharmacological intervention ¶ 5 (2.6%) 33 (17.9%) < 0.001 28 (15.2%) < 0.001 OGTT = 75 g oral glucose tolerance test; FLOX = fluoride-oxalate tube; FC = fluoride-citrate tube; FPG = fasting plasma glucose; PG = plasma glucose; GDM based on Australasian Diabetes in Pregnancy Society (ADIPS) 2014 or 2024 definition as indicated. ADIPS 2014 GDM defined as one or more PG value equal to or above the following thresholds: FPG 5.1 mmol/L, 1h-PG 10.0 mmol/L, 2h-PG 8.5 mmol/L. ADIPS 2025 GDM defined as one or more PG value equal to or above the following thresholds: FPG 5.3 mmol/L, 1h-PG 10.6 mmol/L, 2h-PG 9.0 mmol/L. Ɨ T1 time period before implementation of FC tubes (OGTT collection between 01/09/2017 and 31/08/2019); T2 time period after implementation of FC tubes (OGTT collection between 01/10/2019 and 30/09/2021). ǂ In the T2 time period the ‘No GDM’ group using ADIPS 2025 criteria included 22 pregnancies that did receive intervention based on ADIPS 2014 criteria (18 non-pharmacological intervention; 2 metformin, 2 insulin) § Non-pharmacological intervention group were recommended diet and lifestyle modifications, and/or self-monitoring of blood glucose. ¶ In addition to diet and lifestyle modifications, and/or self-monitoring of blood glucose, the pharmacological intervention group were recommended metformin: 5 (T1); 23 (T2); and/or insulin: 0 (T1); 10 (T2). Data includes women who completed OGTT at or after 24-weeks’ gestation. Data are mean ± standard deviation for continuous variables and number and proportion (%) of T1 or T2 cohort for categorical variables. Two-sided t-test P -value reported for comparison between groups for continuous data and Pearson chi-square test P -value reported for comparison between groups for categorical data. Concomitant with the increased detection of women with fasting hyperglycaemia, 7-fold more women were recommended for pharmaceutical management (Table 1 ) in T2 compared to the T1 period (33 (17.9%) v 5 (2.9%), P < 0.0001). This was also consistent with the reported clinician perception of under-diagnosis of GDM using FLOX tubes. I don’t think … we’re picking up false positives, but I think we’re just picking up those women that were borderline before and now, they’re positive. But I do feel like there’s enough in their outcomes for us to say, you know, when you look back retrospectively that they were GDM. [General Practitioner Obstetrician] I think that this [FC] tube is picking up more people on fasting. So those women that we would have suspected had GDM are getting a higher fasting reading, than I feel like the older [FLOX] tubes would have provided. [General Practitioner Obstetrician] Most (84.8%) of the women who required insulin or metformin in the T2 period would still be identified as having GDM using ADIPS 2025 criteria. At initial FC tube implementation, clinicians acknowledged that preterm inductions may increase with increased detection of GDM. However, they estimated the impact would likely be minimal as Kimberley Clinical Guidelines only indicate pre-term induction for women with GDM taking insulin or metformin, in the absence of other clinical indications (Table 1 ). In the subset of women with known birth outcomes there was no statistical difference in total number of inductions (78/192, 40.6% T1 v 84/180, 46.7% T2, P = 0.152), gestational age at induction, nor any other adverse obstetric outcome between the T1 and T2 periods (Supplementary File 3). Neonatal birth weight and growth-for-gestational-age outcomes were similar between the T1 and T2 periods (3193 g ± 563 v 3185 g ± 569, P = 0.901; LGA: 10.4% v 14.0%, P = 0.286; SGA: 15.1% v 16.8%, P = 0.646, Supplementary File 3). None of the five recorded stillbirths were in pregnancies with GDM; two were for pregnancies that had normoglycemic OGTT and three were for pregnancies with no OGTT performed. There was no statistical difference in any other adverse newborn outcome between T1 and T2 (Supplementary File 3). Ecological system: Pathology testing Most barriers to implementation were encountered when updating relevant pathology testing systems to incorporate FC tubes. The Statewide public pathology service supply Kimberley ACCHOs with the Royal College of Pathologists Australasia recommended blood collection tubes for the tests they perform. While they would not supply FC tubes, they agreed to accept them for glucose measures in the Kimberley region. As FC tube acceptance was not initially reflected in the online test directory, staff turnover increased the risk of FC tubes being rejected at specimen reception. For example, during the audit of medical records one patient attempted the OGTT but was unable to continue. The fasting sample was then rejected by pathology. We have had a change of staff in [Town A] and they queried the use of FC mix tubes for glucose analysis on our analysers and reporting of these patient results. After talking with the few resident staff and [Pathology Manager] in [Town A], I understand that these were in use during the ORCHID study and have continued to be used for [O]GTT's due to the improved results returned. [Acting Medical Scientist in Charge] This was addressed either by clinicians informing the ORCHID team and team members liaising with the pathology laboratory, or central pathology staff identifying the issue and reminding local Kimberley pathology staff. To rectify this at a system level the ORCHID team communicated all these issues with central pathology staff as they occurred and continued to advocate for collection guidelines to be updated (03/04/2024). Sourcing FC tubes In the first year of implementation, excess FC tubes from the ORCHID paired sample study were provided to Kimberley ACCHOs. During the study the ORCHID team experienced delays in receiving tubes from the Australian distributor. The tubes could take up to three months from ordering to arrive in the Kimberley region, reducing shelf life on receipt. Ordering systems were put in place to address these issues (Table 2 , Supply chain). As FC tubes are a special item the ORCHID team continue to provide ongoing support. Another barrier to procurement was related to the minimum order (1200 tubes), with the Kimberley the only place in Australia using FC tubes for routine clinical practice. Consequently, KAMS would place an annual minimum order and then distribute the tubes to their member services. This also involved establishing an ordering system between KAMS and its member services. Advocacy Broad stakeholder engagement, consultation and advocacy have been embedded in the ORCHID Study. This has included over 50 presentations to Aboriginal community members, health professionals from ACCHOs, WACHS, and Diabetes WA, and laboratory staff. This engagement led to JM and EJ being invited to join the National Harmonisation Glucose Preanalytical Working Party, and preparation of a review paper assessing impact of variations in specimen handling on GDM diagnosis.( 12 ) Supporting changes to Australian blood sample collection protocols to improve accuracy of glucose measurements, the publication will be the cornerstone of the Working Group’s position statement for Australian Pathology providers. The Working Group was invited to advise on the revision of Australasian Diabetes in Pregnancy Society consensus guidelines for the testing and diagnosis of GDM in Australia (personal communication). The ORCHID team continues to advocate for FC tubes in OGTTs across Australia, while still supporting KAMS and member services in the use of FC tubes. Discussion Our study demonstrated that improved OGTT accuracy though use of FC tubes increased identification of women needing insulin to manage their GDM (10 of 73 FC v 0 of 28 FLOX). Perception that FLOX tubes missed women requiring more intensive management of hyperglycaemia was reflected in clinician views. This increase was likely due to improved detection of fasting hyperglycaemia. In another Australian cohort, fasting plasma glucose ≥ 5.3 mmol/L at diagnosis was an independent predictor of insulin therapy.( 38 ) GDM incidence increased 2.8-fold with FC tubes to 40% of women tested. Initially, clinicians expressed apprehension regarding the impact of potential overdiagnosis of GDM on women. Over time there was recognition of missed GDM diagnoses with FLOX tubes. They were also concerned about increased burden on staff and resources to manage patients with GDM. Remote Kimberley ACCHOs were able to accommodate the increase in workload during the T2 period. However, considering remote health workforce turnover and retention issues,( 38 ) we cannot comment on long-term sustainability. The recent shift to new elevated GDM diagnostic criteria in Australia would significantly reduce workload in the Kimberley (28% v 40% GDM cases of those tested) while still identifying most (84%) of the women who required more intensive pharmaceutical management. There is ongoing debate on GDM screening and balancing benefit and harm of treatment.( 39 ) This includes concerns that management of women with mild hyperglycaemia may not improve birth outcomes.( 40 ) Consequently, GDM diagnosis in these women may cause unnecessary psychological harm, including feelings of shock, distress, guilt, shame, stigma, fear and anxiety.( 41 ) Only one other jurisdiction in Australia has reported on the impact of addressing preanalytical glycolysis in OGTT samples. The Australian Capital Territory (ACT) Pathology implemented rapid centrifugation of FLOX tubes in 2017.( 42 , 43 ) The 2.8-fold increase in GDM in the Kimberley was significantly higher than the 1.4- to 1.8-fold increase reported in the ACT population after addressing glycolysis. Several factors may explain these findings: differences in remoteness leading to more significant delays to sample processing; differences in models of care (antenatal and GDM management) and GDM risk; and potential positive bias in plasma glucose when using FC tubes.( 12 , 29 ) In the absence of a definitive explanation for this variation in bias, some Australian groups have recommended caution before adopting FC tubes.( 42 , 44 , 45 ). Robust studies directly comparing FC tubes to the HAPO ice-slurry preanalytical protocol may determine if a post-analytical correction factor is required. Early in FC tube implementation, clinicians also raised concerns about potential increased intervention at birth. In Australia, inductions of labour have increased over the past 20 years to 34% of deliveries.( 46 ) Most Australian women who have experienced induction of labour express a desire to avoid induction in future pregnancies.( 46 ) The total number of inductions of labour remained similar between time periods. Notably, five stillbirths were recorded during the entire audit, but none were for women managed for GDM. Most of the barriers to FC tube implementation were at the ecological system level.( 22 ) Supply chain issues, cost, lack of formal peak body endorsement and pathology laboratory staff turnover impacted FC tube implementation. Formal Australasian Association of Clinical Biochemistry and Laboratory Medicine, and Royal College of Pathologists Australasia recommendation of FC tubes should increase local demand. This would likely mitigate supply and wastage issues by encouraging local stock distribution, smaller minimum order size and reduced delivery times. There have been no formal reports of barriers to accessing FC tubes in countries that recommend these tubes,( 15 , 16 , 18 , 47 ) other than during global tube shortages in the COVID-19 pandemic.( 48 ) However, it should be noted that all these jurisdictions are proximal to FC tube manufacturers compared to Australia. This observational study had some limitations. While some remote WACHS sites also implemented FC tubes in 2019 they were unable to be included as we did not have access to WACHS data. Qualitative interviews were designed to explore clinician experiences of the pregnancy OGTT in general and did not include direct questions about FC tube use; interviewees raised these observations without prompting. These quantitative and qualitative data were collected retrospectively. As the study was a pragmatic evaluation of impact of FC tube implementation on GDM diagnosis and clinic workload, it was not powered to detect changes in obstetric and neonatal outcomes. However, no significant difference in LGA and SGA frequency was observed in the larger ACT cohort study comparing delayed versus rapid centrifugation ( N :8035 v 7686; LGA 10.1% v 10.7%, P > 0.05; SGA 11.3% v 11.2%, P > 0.05).( 43 ) Larger cohorts with detailed assessment of glycaemic management are required to evaluate whether increased management of GDM with the use of FC tubes translate to improved birth outcomes. The ORCHID study had been active in the Kimberley region for five years prior to FC tube implementation. High staff turnover of clinic staff and subsequent institutional amnesia was factored into the implementation of FC tubes. This was addressed through regular communication with clinic staff, including in-services to antenatal clinicians on ORCHID Study findings. We are unable to assess the impact of enhanced clinician awareness of GDM and preanalytical glycolysis on antenatal care between time periods as separate from the impact of using FC tubes. Another important study limitation is the low OGTT completion (~ 50%) in both time periods. This is similar to previous findings for rural and remote Australian settings.( 49 ) The T2 period coincided with the COVID-19 pandemic. Pragmatic guidelines to triage to full OGTT based on fasting plasma glucose ≥ 4.7 mmol/L may account for the slight increase in incomplete OGTT (10, T1 v 20, T2).( 50 ) It is also possible that the OGTT was completed at a private pathology provider or WACHS clinic, with results not shared to the ACCHO electronic medical record. However, the study team reviewed the shared My Health Record (when available), progress notes and communications between shared care services for any record of OGTT completion. Other than propensity to overweight there were no differences in maternal characteristics between women who did and did not complete an OGTT. It is therefore likely that a significant number of women with GDM are not managed appropriately because they do not complete testing. Other studies suggest low completion is due to poor acceptability of the OGTT.( 49 ) Investigation of more acceptable alternative tests is warranted to ensure appropriate antenatal care for this high-risk population. Conclusions Implementation of FC tubes resulted in improved identification of women with GDM requiring pharmaceutical intervention, with no adverse impact on birth outcomes. Findings from this study support the case for Australian stakeholders to formally recommend FC tube use in pregnancy OGTTs for rural, remote and low resource settings. Acknowledging some of the local barriers to implementation of FC tubes described in the Kimberley region, a collective rather than siloed approach will likely improve success. Abbreviations ACCHOs Aboriginal Community Control Health Organisations ACT Australian Capital Territory ADIPS Australasian Diabetes in Pregnancy Study Groups CONSIDER Consolidated criteria for strengthening reporting of health research involving Indigenous peoples DSF Dynamic Sustainability Framework FLOX Fluoride-Oxalate (blood collection tube) FC Fluoride-Citrate (blood collection tube) GDM Gestational Diabetes Mellitus HAPO Hyperglycaemia and Adverse Pregnancy Outcomes (study) KAHPF Kimberley Aboriginal Health Planning Forum KAMS Kimberley Aboriginal Medical Services LGA Large-for-gestational-age newborn OGTT Oral Glucose Tolerance Test ORCHID Optimisation of Rural Clinical and Haematological Indicators for Diabetes in pregnancy (study; currently: optimisation of screening and management for diabetes in pregnancy study) PDSA Plan-Do-Study-Act REDCap Research Electronic Database Capture StaRI Standards for Reporting Implementation Studies SGA Small-for-gestational-age newborn T1 Time period 1 captures the 24-months prior to FC tube implementation (01/09/2017 – 31/08/2019) T2 Time period 2 captures the 24-months post-FC tube implementation (01/10/2019 – 30/09/2021) WA Western Australia WACHS Western Australian Country Health Service Declarations Ethics approval and consent to participate This study adhered to the Declaration of Helsinki. The ORCHID Study was endorsed by the KAHPF Research Subcommittee. Ethics approval was obtained from the Western Australia Aboriginal Health Ethics Committee (Project reference 584) and The University of Western Australia Human Research Ethics Committee (Project reference 2019/RA/4/20/5572). The project aligns with the Australian National Health and Medical Research Council’s guidelines for ethical conduct in Aboriginal and Torres Strait Islander Hearth Research.(51) This study included data from two groups of participants. 1. Retrospective clinical audit: At patient registration Kimberley ACCHOs obtained consent for use of patient deidentified information to improve their clinical care through audits. As Kimberley ACCHOs requested support from the ORCHID Study for the implementation and evaluation of FC tube usage for the purpose of quality improvement, they granted collective consent for the ORCHID study to access relevant patient data. The Western Australian Aboriginal Health Ethics Committee waived requirement for individual informed consent for inclusion of this data in the audit. 2. Qualitative semi-structured interviews: All participants provided informed written consent. Consent for publication The Kimberley ACCHOs Lead Clinicians Forum and relevant staff (antenatal clinicians, managers, CEOs) from participating ACCHOs were provided with a full draft of the paper for comment. No changes were requested. Data availability Data cannot be shared publicly because of the ethical restrictions involved in working with a small population of Aboriginal people in Western Australia. The minimal dataset will be made available upon request for researchers who meet the criteria for access to confidential data. Interested researchers should contact Western Australian Health Ethics Committee at [email protected] and the Kimberley Aboriginal Health Research Alliance at [email protected] . Competing interests The authors declare that they have no conflicts of interest. Funding Research reported in this publication was supported by the Medical Research Future Fund under grant number MRFMB000045. The funder had no role in the study design, conduct of the study, analysis, or dissemination of findings. Author Contribution ES, EJ, LA, and JM conceived the idea of implementing FC tubes and developed the implementation evaluation. ES led this implementation project, supported by JM and EJ. ES, EJ and JM provided individual support and clinic level in-services to participating ACCHOs. EJ and MH collected quantitative data. EJ designed the quantitative database and led the statistical analysis. ES, EJ, AK and JM collected and analysed the qualitative data. The initial draft manuscript was prepared by ES, MH, EJ and JM. All authors contributed to the interpretation of results. All authors participated in reviewing and editing, and gave their approval for the final manuscript. 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Crowther CA, Samuel D, McCowan LME, Edlin R, Tran T, McKinlay CJ. Lower versus Higher Glycemic Criteria for Diagnosis of Gestational Diabetes. N Engl J Med. 2022;387(7):587–98. Davis D, Kurz E, Hooper M-E, Atchan M, Spiller S, Blackburn J, et al. The holistic maternity care needs of women with Gestational Diabetes Mellitus: A systematic review with thematic synthesis. Women Birth. 2024;37(1):166–76. Potter JM, Hickman PE, Oakman C, Woods C, Nolan CJ. Strict Preanalytical Oral Glucose Tolerance Test Blood Sample Handling Is Essential for Diagnosing Gestational Diabetes Mellitus. Diabetes Care. 2020;43(7):1438–41. Hutchinson J, Knight-Agarwal CR, Nolan CJ, Davis D. Changes to Gestational Diabetes Mellitus (GDM) Testing and Associations with the GDM Prevalence and Large- and Small-for-Gestational-Age Infants—An Observational Study in an Australian Jurisdiction, 2012–2019. Diabetology. 2025;6(6):54. Song D, Lia M, Hurley JC. Recommended pre-analytical plasma glucose sampling methodology may distort gestational diabetes mellitus prevalence: implications for diagnostic thresholds. Diabet Med. 2019;11:11. Carey R, Lunt H, Heenan HF, Frampton CM, Florkowski CM. Collection tubes containing citrate stabiliser over-estimate plasma glucose, when compared to other samples undergoing immediate plasma separation. Clin Biochem. 2016;49(18):1406–11. Ormsby SM, Keedle H, Dahlen HG. Womenʼs reflections on induction of labour and birthing interventions and what they would do differently next time: A content analysis. Midwifery. 2025;140:104201. American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 2014;37(Supplement 1):S81–90. Gosselin RC, Bowyer A, Favaloro EJ, Johnsen JM, Lippi G, Marlar RA, et al. Guidance on the critical shortage of sodium citrate coagulation tubes for hemostasis testing. J Thromb Haemost. 2021;19(11):2857–61. Kirke AB, Atkinson D, Moore S, Sterry K, Singleton S, Roxburgh C, et al. Diabetes screening in pregnancy failing women in rural Western Australia: An audit of oral glucose tolerance test completion rates. Aust J Rural Health. 2019;27(1):64–9. Australasian Diabetes in Pregnancy Society (ADIPS), the Australian Diabetes Society (ADS), the Australian Diabetes Educators Association (ADEA), Diabetes Australia (DA). Diagnostic Testing for Gestational diabetes mellitus (GDM) during the COVID 19 pandemic: Antenatal and postnatal testing advice. Joint Position Statement. 2020. Available from: https://www.adips.org/documents/COVID-19GDMDiagnosis030420ADIPSADSADEADAforWebsite.pdf . Accessed 16 July 2025. National Health and Medical Research Council. Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders. Canberra, Online: Commonwealth of Australia. 2018. Available from: https://www.nhmrc.gov.au/about-us/resources/ethical-conduct-research-aboriginal-and-torres-strait-islander-peoples-and-communities . Accessed 16 July 2025. Additional Declarations No competing interests reported. Supplementary Files SupplementaryFile1CONSIDER.docx SupplementaryFile2StaRI.docx SupplementaryFile3Table1.docx Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 21 Sep, 2025 Reviewers agreed at journal 18 Sep, 2025 Reviewers invited by journal 11 Sep, 2025 Editor assigned by journal 09 Sep, 2025 Editor invited by journal 22 Aug, 2025 Submission checks completed at journal 21 Aug, 2025 First submitted to journal 21 Aug, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7316550","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":515747713,"identity":"149a59dd-64cb-4168-8baa-a9933c208643","order_by":0,"name":"Erica P Spry","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA8klEQVRIiWNgGAWjYFACxgYog/kAhD5AvBa2BGK1wAGPAXFa+KUPN374wVCXZz4j55s0Tw2DHN+NBMbPPHi0SPYlNkv2MBwulrmRu02a5xiDseSNBGZpfFoMzjC2MfAwHEicIQHUksPGkLjhRgIDXi32QC2MfxjqgFpynknn/GOoB2ph/o3XFh7GNmYeBmaQFjbp3DaGBIMbCWx4bZE4w9gsLWNwuFiC55mx9d8+CcOZZx62Wc7Bo4W/h/3hxzcVdXkS7MkPb874ZiPPdzz58I03eLRAnceQwCCQALaVASly8YMEBv4DRCkcBaNgFIyCEQgAFOFG3SM9JNQAAAAASUVORK5CYII=","orcid":"","institution":"Kimberley Aboriginal Medical Services","correspondingAuthor":true,"prefix":"","firstName":"Erica","middleName":"P","lastName":"Spry","suffix":""},{"id":515747714,"identity":"74727bac-fff6-4855-bfc1-fee14c073034","order_by":1,"name":"Emma L Jamieson","email":"","orcid":"","institution":"The University of Western Australia","correspondingAuthor":false,"prefix":"","firstName":"Emma","middleName":"L","lastName":"Jamieson","suffix":""},{"id":515747715,"identity":"421bc87e-00d1-44b0-a4dc-b6f3c13cd6ca","order_by":2,"name":"Lorraine Anderson","email":"","orcid":"","institution":"Kimberley Aboriginal Medical Services","correspondingAuthor":false,"prefix":"","firstName":"Lorraine","middleName":"","lastName":"Anderson","suffix":""},{"id":515747716,"identity":"fc52f283-cf0d-4bf9-a023-3d55bebddec1","order_by":3,"name":"Mark A Hoey","email":"","orcid":"","institution":"The University of Western Australia","correspondingAuthor":false,"prefix":"","firstName":"Mark","middleName":"A","lastName":"Hoey","suffix":""},{"id":515747717,"identity":"88174d01-6b91-45c5-9fda-04014d6bdd87","order_by":4,"name":"Andrew B Kirke","email":"","orcid":"","institution":"The University of Western Australia","correspondingAuthor":false,"prefix":"","firstName":"Andrew","middleName":"B","lastName":"Kirke","suffix":""},{"id":515747718,"identity":"d5ccce99-b4c9-4cbc-bce9-9fa8b1adcc43","order_by":5,"name":"Julia V Marley","email":"","orcid":"","institution":"The University of Western Australia","correspondingAuthor":false,"prefix":"","firstName":"Julia","middleName":"V","lastName":"Marley","suffix":""}],"badges":[],"createdAt":"2025-08-07 08:38:29","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7316550/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7316550/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":91605610,"identity":"3c787df9-d1ad-4ff7-b28b-85bdbb3e7ebc","added_by":"auto","created_at":"2025-09-18 09:19:33","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":113178,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlowchart for inclusion in the OGTT audit in time period 1 and 2.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOGTT = 75 g oral glucose tolerance test; FLOX = fluoride-oxalate; FC = fluoride-citrate. \u003csup\u003eƗ\u003c/sup\u003eT1 period before implementation of FC tubes (OGTT collection using FLOX tubes between 01/09/2017 and 31/08/2019); T2 period after implementation of FC tubes (OGTT collection using FC tubes between 01/10/2019 and 30/09/2021). Women without OGTT data were assigned to a time period based on the date at 28\u003csup\u003e+6\u003c/sup\u003e-weeks’ gestation. \u003csup\u003e§\u003c/sup\u003eFC tubes used for OGTT done as part of ORCHID Phase 1 cohort. \u003csup\u003e¶\u003c/sup\u003eFC tubes not implemented at collection site.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7316550/v1/d46c9d0e5598bc99dce04ae9.png"},{"id":91609718,"identity":"4356dda3-eeef-4a23-99b3-8f5e8f116d96","added_by":"auto","created_at":"2025-09-18 09:43:34","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1190141,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7316550/v1/11ddcb5e-f2c3-4599-8393-7a0bcdfa1589.pdf"},{"id":91607364,"identity":"059bebf4-51c5-4ac1-9cc9-f1ca6305b863","added_by":"auto","created_at":"2025-09-18 09:27:33","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":95080,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryFile1CONSIDER.docx","url":"https://assets-eu.researchsquare.com/files/rs-7316550/v1/ba8605e07ab6d8fb9b449527.docx"},{"id":91607361,"identity":"4f750b91-3049-4452-88b0-57a194d81631","added_by":"auto","created_at":"2025-09-18 09:27:33","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":88861,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryFile2StaRI.docx","url":"https://assets-eu.researchsquare.com/files/rs-7316550/v1/3147b3892fc964e829c6460e.docx"},{"id":91605621,"identity":"b88ccbdf-4e06-4387-8c5b-731676cbb3fd","added_by":"auto","created_at":"2025-09-18 09:19:33","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":25884,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryFile3Table1.docx","url":"https://assets-eu.researchsquare.com/files/rs-7316550/v1/f9d5aa9ee58e27a93ac347a9.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"A mixed methods assessment of implementation of fluoride-citrate tubes for pregnancy oral glucose tolerance tests: glucose stabilisation improves identification of Aboriginal women requiring pharmaceutical intervention for gestational diabetes","fulltext":[{"header":"Contributions to the literature","content":"\u003cul\u003e\n \u003cli\u003eResearch has shown that testing for gestational diabetes (high blood glucose levels in pregnancy) is impacted by sample handling before measurement. In rural and remote Australia up to 2 in 3 women with gestational diabetes are missed due to this sample instability.\u003c/li\u003e\n \u003cli\u003eWe found that implementing new sample collection tubes containing fluoride-citrate in remote Australian settings improved sample stability. While there were some barriers to implementation, they were overcome through engagement with clinicians and pathology providers and refinement of ordering processes.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eThese findings will inform Australian jurisdictions considering implementing fluoride-citrate tubes when adopting new 2025 diagnostic criteria.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Background","content":"\u003cp\u003eThere is clear evidence for a continuous linear association between maternal glycaemia and adverse pregnancy outcomes.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) Management of gestational diabetes mellitus (GDM), or hyperglycaemia first detected in pregnancy, can improve pregnancy outcomes.(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) Universal screening for GDM, generally with a one-step oral glucose tolerance test (OGTT), is recommended for all pregnant women without known diabetes.(\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) Repeat testing to confirm GDM is not recommended as it would delay initiation of management.(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) Therefore, accurate glucose measurement is paramount to reduce diagnostic errors.(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/p\u003e\u003cp\u003ePre-analytical instability of glucose in OGTT samples is a significant, yet often underappreciated factor that can impact detection of GDM.(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) Most jurisdictions in Australia rely on fluoride, a latent glycolytic inhibitor, in fluoride-oxalate (FLOX) tubes to stabilise glucose in OGTT samples. However, delays in processing FLOX samples can result in significant \u003cem\u003ein vitro\u003c/em\u003e glycolysis,(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) leading to between 40% and 62% missed GDM diagnoses of those tested with current criteria.(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eInherently long distances to transport specimens for laboratory analysis for most women living in rural and remote locations exacerbates this diagnostic error. In the Optimisation of Rural Clinical and Haematological Indicators for Diabetes in pregnancy (ORCHID) study the median delay to laboratory processing of samples was 5-hours (2.3- to 124-hours) from collection of the first fasting OGTT specimen.(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) Delays were worse in remote clinics, including those in the Kimberley region of Western Australia, where 25% of OGTT samples arrived at the laboratory more than 24-hours post collection. In these settings, the maximum \u003cem\u003ein vitro\u003c/em\u003e loss of glucose impacted specimens all three OGTT timepoints.(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) This variation in diagnostic processes due to geographical disadvantage leads to diagnostic inequity for women with GDM.(\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e) Improving OGTT sample stability will become even more imperative in rural and remote Australia when new elevated diagnostic criteria for GDM are implemented.(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eCollection tubes with a combination of fluoride and citrate buffer (FC) have been recommended for use for pregnancy OGTT in other countries for the past three to 14 years: Croatia (2010), the United States of America (2011), Germany (2014), Sweden (2015), Austria and Switzerland (2018), and Norway (2021).(\u003cspan additionalcitationids=\"CR16 CR17\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e) Citrate acidifies the sample which immediately stabilises plasma glucose without requirement for prompt plasma separation or storage in ice.(\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) The simplified pre-analytical process makes FC tubes a pragmatic solution for low-resource settings and rural and remote centres.(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e) However, concerns have been raised about potential overdiagnosis of GDM following reports of up to 0.37 mmol/L bias in glucose measures from FC tubes compared to rapid centrifugation.(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eIn the ORCHID cohort, FC tubes were estimated to improve both GDM detection and identification of pregnancies at risk of macrosomia when compared to FLOX tubes.(\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) To improve pregnancy outcomes, the Kimberley Lead Clinicians Forum endorsed FC tubes for all pregnancy OGTT performed in Kimberley Aboriginal Community Controlled Health Organisations (ACCHOs) in September 2019. To date, Kimberley ACCHOs are the only healthcare providers in Australia to formally implement FC tubes.(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e) To better embed the FC tubes into routine clinical practice, Kimberley ACCHOs needed to understand factors important in \u0026lsquo;real world\u0026rsquo; utilisation and implementation, such as clinical support required, and clinic and laboratory staff acceptability.\u003c/p\u003e\u003cp\u003eThis paper assessed FC tube implementation processes and outcomes in Kimberley ACCHOs using modified domains of the Dynamic Sustainability Framework (DSF).(\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e) We interpreted the DSF domains to refer to FC tube implementation as the intervention; the regional clinic systems and training as the practice setting; and pathology laboratories, supply chain and general Australian context as the ecological system. Assessment included a retrospective evaluation of GDM detection and management, and potential impact of proposed new cut-points.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis study used a mixed methods approach to explore implementation outcomes using the DSF.(\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e) This framework facilitates examination of how the intervention, and practice and ecological settings enable or inhibit FC tube implementation into routine clinical practice, while accounting for changes over time.\u003c/p\u003e\u003cp\u003eThis study aligns to the Consolidated criteria for strengthening reporting of health research involving Indigenous peoples (CONSIDER),(\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e) and Standards for Reporting Implementation Studies (StaRI),(\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e) and our statements against these standards are available (Supplementary Files 1 and 2).\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eGovernance and Indigenous Data Sovereignty\u003c/h2\u003e\u003cp\u003eAboriginal culture, family and community are central to the ORCHID Study. Aboriginal Community Boards and Investigators provide Aboriginal leadership and oversight. This study, which is integrated within the major health service providers in regional, rural and remote WA, uses existing governance structures (e.g., regional Aboriginal health planning forums). It includes Aboriginal people, clinicians, administrators and policy makers as core members of the research team. Participating Aboriginal communities and ACCHOs are equal partners in the analysis, interpretation and publication of project data. They have provided letters of support and research collaborative agreements, which are updated to account for new phases of the project. Agreement details include:\u003c/p\u003e\u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eAboriginal community and ACCHO involvement in the ORCHID Study, including monitoring the research.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eCopyright and intellectual property management; a key part of the governance arrangement is adherence to the principals of Indigenous Data Sovereignty.(\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e) Project data and research findings belong to Aboriginal communities and ACCHOs.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eExpectations of the ORCHID team (e.g., regular reports to be provided, permission to publish and disseminate project findings to be sought), and the resources we will provide.\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e\u003cp\u003eKimberley ACCHOs (Kimberley Aboriginal Medical Services, Broome Regional Aboriginal Medical Service, Derby Aboriginal Health Service, Ord Valley Aboriginal Health Service, and Yura Yungi Medical Service) requested support from the ORCHID Study for the implementation and evaluation of FC tube usage. Therefore, for the audit there was a more informal approach between participating ACCHOs and the ORCHID team. This included an understanding that the project would adhere to the conditions set out in the research agreements.\u003c/p\u003e\u003cp\u003e As the project was a retrospective clinical audit that aimed to identify areas for quality improvement collective consent was granted by each Kimberley ACCHO. They also provided approval for ORCHID team members to access their patients\u0026rsquo; electronic medical records (MMEx, 2024 ISA Healthcare Solutions) and Stork Perinatal Dataset Discharge Summaries. Confidentiality was a key consideration in the audit. Bulk data exports were imported into Research Electronic Database Capture (REDCap). Personal identifiers were only used to link the results of tests, reports and procedures for the same person from different locations. For manually entered data (e.g. GDM management) the medical record identifier was recorded for each patient to enable linking of batch exported data (e.g., weight, height). Results were reported on de-identified data only.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003ePositionality\u003c/h3\u003e\n\u003cp\u003eES is a Bardi Jawi traditional owner, a mother of four and experienced GDM with her third child. ES is employed in a joint research position through KAMS and the Rural Clinical School of Western Australia and is based in Broome. She joined the ORCHID Study in 2016 as an Aboriginal Research Officer and is currently a Senior Aboriginal Research Officer (KAMS) and Research Fellow (The University of Western Australia). She co-leads this and another diabetes project.\u003c/p\u003e\u003cp\u003eEJ has been involved in diabetes research projects for 23 years. For the past 10 years she coordinated the ORCHID study from rural Western Australia and completed her PhD on optimising screening for GDM. This included evaluating and reporting on underdiagnosis of GDM due to preanalytical glycolysis in rural and remote WA.\u003c/p\u003e\u003cp\u003eLA traces her Aboriginal heritage to the Palawa people of Tasmania. She has many years\u0026rsquo; experience as a lead clinician in rural and remote Western Australia and rural New Zealand. She is the Medical Director of the KAMS (from 2019), chairs the Kimberley ACCHO Lead Clinicians Forum, and supported implementation of FC tubes into routine clinical practice across Kimberley ACCHOs.\u003c/p\u003e\u003cp\u003eMH is a junior doctor who has worked in rural Western Australia for the past two years, including in antenatal care in the Great Southern region. He was involved with data collection and analysis for the retrospective audit (rural research student MD project). As part of his capacity building, he presented his project findings to the Kimberley ACCHO Lead Clinicians Forum.\u003c/p\u003e\u003cp\u003eAK is a rural General Practitioner Obstetrician with 18 years' experience in antenatal care, including a significant number of pregnant women diagnosed with GDM. He is completing a PhD on barriers and enablers of GDM screening in regional, rural and remote WA.\u003c/p\u003e\u003cp\u003eJM is based in Broome and has been conducting collaborative health services research, predominately with Kimberley ACCHOs, over the past 19 years. She led the development of the ORCHID Study.\u003c/p\u003e\u003cp\u003eES, EJ and JM regularly provide individual support and clinic level in-services to clinicians participating in the ORCHID Study. ES led this FC tube implementation project, supported by the other two ORCHID Study co-leads (JM, EJ).\u003c/p\u003e\n\u003ch3\u003eResearch Design\u003c/h3\u003e\n\u003cp\u003eThe quantitative component descriptively analysed a retrospective audit of ACCHO electronic medical records to explore impact of FC tube use on GDM incidence and management. The data are reflective of two time periods: Time period 1 (T1) captures the 24-months prior to FC tube implementation (01/09/2017\u0026ndash;31/08/2019); Time period 2 (T2) captures the 24-months post-FC tube implementation (01/10/2019\u0026ndash;30/09/2021). Rates of screening using the OGTT at 24\u0026ndash;28 weeks gestation were also assessed during each time period.\u003c/p\u003e\u003cp\u003eAcceptability,(\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e) barriers and enablers, and resources required to support implementation were assessed using qualitative descriptive approaches.(\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e) From the start of the implementation process, ES [Aboriginal researcher] kept detailed notes on all contact with relevant stakeholders. ES and EJ provided support for ordering FC tubes, including tracking arrival and expiry dates. ORCHID Study newsletters and papers were also shared with stakeholders and ES provided friendly reminders for clinicians to use FC tubes for all pregnancy OGTTs. Clinic staff concerns were noted and followed up. All details of stakeholder contact including meeting minutes, brief reflections, and processes of developing the ORCHID Study FC tube policy guidelines were recorded by ES in the KAMS \u0026lsquo;Plan Do Study Act (PDSA) and Action Plan document\u0026rsquo; stored on their Quality Management System (Logiqc). ORCHID co-leads (ES, EJ, JM) stored all relevant emails with ACCHOs, laboratory staff and suppliers. Clinician comments about FC tubes from another ORCHID sub-study (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e) were noted.\u003c/p\u003e\n\u003ch3\u003eRegional Setting\u003c/h3\u003e\n\u003cp\u003eThe Kimberley region of Western Australia (WA) covers 423,517 square kilometres and consists of 274 remote and very remote communities (Modified Monash Model remoteness category 6\u0026ndash;7).(\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e) In 2021, 41.1% of the Kimberley population (14,408) identified as Aboriginal and/or Torres Strait Islander people.(\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e) A total of 3,371 births were recorded for Kimberley women between 2017 and 2021 inclusive.(\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eAntenatal care for Kimberley Aboriginal women is generally shared between the Western Australian Country Health Services (WACHS) and ACCHOs.(\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e) KAMS is a member based, regional ACCHO that supports and represents the interests of eight independent Kimberley ACCHOs (member services). KAMS also delivers culturally appropriate primary health care services to five remote Aboriginal Communities.\u003c/p\u003e\n\u003ch3\u003eClinical Setting\u003c/h3\u003e\n\u003cp\u003e Endorsed by the Kimberley Aboriginal Health Planning Forum (KAHPF), Kimberley Clinical Guidelines aim to standardise the screening and management of prevalent health conditions in the Kimberley. Hence, regional guidelines can differ from state or national guidelines. The KAHPF Diabetes in Pregnancy Clinical Guideline (2017), which included Australasian Diabetes in Pregnancy Society (ADIPS) 2014 screening and diagnostic recommendations, was in use throughout the audit (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).(\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e)\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eSummary of Kimberley Aboriginal Health Planning Forum Clinical Guideline for Diabetes in Pregnancy (2017)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"1\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eScreening\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026bull; An OGTT as early in pregnancy as practicable for women with risk-factors for diabetes\u003c/p\u003e\u003cp\u003e\u0026bull; An OGTT between 24- and 28-weeks\u0026rsquo; gestation for all pregnant women without known diabetes\u003c/p\u003e\u003cp\u003e\u0026bull; GDM defined as one or more OGTT values equal to or above thresholds: FPG 5.1 mmol/L, 1h-PG 10.0 mmol/L, 2h-PG 8.5 mmol/L\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eManagement\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026bull; Initiation of metformin for women with GDM based on elevated self-monitoring of blood glucose levels:\u003c/p\u003e\u003cp\u003eo Fasting: \u0026ge;5.1 mmol/L once or more in a week\u003c/p\u003e\u003cp\u003eo Two-hour post-prandial: \u0026ge;6.7 mmol/L twice or more in a week\u003c/p\u003e\u003cp\u003e\u0026bull; Metformin dosage: 500 mg daily, increasing weekly as required with 2000 mg daily as maximum dose\u003c/p\u003e\u003cp\u003e\u0026bull; Initiation of insulin alongside metformin when blood glucose targets were not achieved with metformin alone\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eMode and timing of delivery\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026bull; No indication for pre-term induction for women not on insulin or metformin and with no evidence of macrosomia, polyhydramnios or intra-uterine growth restriction\u003c/p\u003e\u003cp\u003e\u0026bull; Arrange an elective birth between 38- and 40-weeks gestation for women on insulin or metformin to prevent stillbirth without increasing neonatal morbidity\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"1\"\u003eOGTT\u0026thinsp;=\u0026thinsp;oral glucose tolerance test, FPG\u0026thinsp;=\u0026thinsp;fasting plasma glucose, PG\u0026thinsp;=\u0026thinsp;plasma glucose, GDM\u0026thinsp;=\u0026thinsp;gestational diabetes\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eTo optimise sample collection, most pregnancy OGTTs were performed in Kimberley ACCHO and WACHS remote clinics, rather than dedicated pathology collection centres. The standard OGTT pre-analytical protocol at all sites was for storage of samples at room temperature before batch transportation to laboratory for analysis. Prior to FC tube implementation, FLOX tubes were used for all pregnancy OGTT collections (BD: Vacutainer Fluoride Tube, 367921, 2 mL) with exception for some ORCHID Study participants. ORCHID Phase One (FLOX tubes) involved six Kimberley ACCHOs from 2015\u0026ndash;2018 and included a small, paired sample study (FLOX v FC tubes; \u003cem\u003eN\u003c/em\u003e\u0026thinsp;=\u0026thinsp;6) conducted at one Kimberley ACCHO.(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) ORCHID Phase Two (FC tubes) involved two Kimberley ACCHOs from 2020\u0026ndash;2022. Eleven Kimberley clinics implemented FC tubes for all pregnancy OGTTs in September 2019 (nine ACCHO clinics, and three remote WACHS antenatal clinics; Greiner Bio-One: Vacuette FC Mix Tube 454511, 2mL).\u003c/p\u003e\u003cp\u003eThe primary focus of this paper is to describe the implementation in Kimberley ACCHOs. At the time of implementation, only two manufacturers in the world produced FC tubes, and only Greiner Bio-One produced tubes with a granular mixture, which avoided the need for a dilution factor correction for glucose values in FC tubes that had the glucose preservative as a liquid additive.(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e) Neither tube type was stocked in Australia. No post-analytical correction of glucose measures from FC tubes was applied.\u003c/p\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eData analysis\u003c/h2\u003e\u003cp\u003eRetrospective audit\u003c/p\u003e\u003cp\u003eRecords were audited for 1074 pregnant women who attended a Kimberley ACCHO for antenatal care within the T1 and T2 audit periods (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Records were excluded for women requiring early pregnancy management for hyperglycaemia (\u0026lt;\u0026thinsp;24-weeks\u0026rsquo; gestation), including pre-existing diabetes, miscarriage and termination of pregnancy, or delivery prior to 24-weeks\u0026rsquo; gestation. Records included for data analysis were for women with a pregnancy OGTT collection (\u0026ge;\u0026thinsp;24-weeks\u0026rsquo; gestation) within the audit time periods. Women without OGTT data were assigned to an audit period based on the date at 28\u003csup\u003e+\u0026thinsp;6\u003c/sup\u003e-weeks\u0026rsquo; gestation.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eThe OGTT was considered complete if a pathology report with plasma glucose at all three OGTT timepoints was present in the electronic medical record or linked to My Health record (Australian national electronic health record system). In the absence of a pathology report, the OGTT was marked as complete if it was documented in the progress notes (using search term \u0026lsquo;GTT\u0026rsquo;); uploaded antenatal documents (manual search); or correspondence with shared care providers (manual search). Records with incomplete OGTT or OGTT not collected into FLOX tubes in T1 nor FC tubes in T2, based on pathology report or site of collection, were excluded from analysis (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eRisk factors for GDM,(\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e) OGTT results, GDM management and birth outcome data were collected and managed using secure REDCap electronic data capture tools hosted at The University of WA.(\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e) GDM diagnosis was defined by ADIPS 2014 criteria (vide supra).(\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e) In a separate analysis, new ADIPS 2025 criteria (fasting PG\u0026thinsp;\u0026ge;\u0026thinsp;5.3 mmol/L, 1h-PG\u0026thinsp;\u0026ge;\u0026thinsp;10.6 mmol/L, 2h-PG\u0026thinsp;\u0026ge;\u0026thinsp;9.0 mmol/L) were applied retrospectively to the T2 period only.(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e) GDM diagnosis and identification of women requiring insulin or metformin in the T2 period (FC tubes and ADIPS 2025 criteria) were compared with the T1 period (FLOX tubes and ADIPS 2014 criteria).\u003c/p\u003e\u003cp\u003eAdverse birth outcomes were defined by Hyperglycaemia and Adverse Pregnancy Outcomes (HAPO) study definition,(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) noting modification to calculation of newborn birthweight centile. Birthweight centiles were calculated using Global bulk centile calculator, Gestation Related Optimal Weight (GROW) v8.0.6.1,(\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e) adjusting for gestational age, maternal height, maternal weight at first antenatal visit, parity, ethnicity and infant sex. Adjustment for maternal weight made within BMI limits of 18.5\u0026ndash;30 kg/m\u003csup\u003e2\u003c/sup\u003e only. Large-for-gestational-age (LGA) and small-for-gestational-age (SGA) newborn were defined as birthweight greater than 90th centile and less than the 10th centile, respectively.\u003c/p\u003e\u003cp\u003eAll analyses were performed with Stata version 18 (Statacorp). Differences in characteristics between the T1 and T2 periods were compared using t-tests for continuous data and Pearson χ\u003csup\u003e2\u003c/sup\u003e tests for categorical data. \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was defined as statistically significant.\u003c/p\u003e\u003cp\u003eQualitative\u003c/p\u003e\u003cp\u003eRelevant information was extracted from previous qualitative interviews with eight clinicians regarding challenges and enablers of GDM screening.(\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e) As previously described,(\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e) AK conducted semi-structured interviews with clinicians who delivered antenatal care in regional, rural and remote WA. These data were professionally transcribed, coded and analysed using directed qualitative content analysis.(\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e) Any content that referred to FC tube use by Kimberley interviewees was re-analysed (JM, ES, EJ).\u003c/p\u003e\u003cp\u003eThe initial focus of the review of individual documents (e.g., interview transcripts, PDSA, emails) was to identify factors that facilitated or were barriers to implementing FC tubes over time (2019\u0026ndash;2021). This included acceptability of using FC tubes in routine clinical practise and FC tube supply issues. These data were mapped to the modified DFS domains of practice setting and ecological systems.\u003c/p\u003e\u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eIn early 2019, data analysis from a small ORCHID Study paired-sample cohort showed the efficacy of FC tubes in preventing glycolysis compared to usual Kimberley practice for OGTT collections (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, Preanalytical process). Findings were immediately communicated with the KAMS Medical Director who provided initial endorsement for adoption of FC tubes. FC tubes were formally endorsed for use in all pregnancy OGTTs collected by Kimberley ACCHOs following presentation of findings at the Kimberley ACCHO Lead Clinicians Forum. Endorsement was conditional on the ORCHID team providing the initial batch of FC tubes and auditing the impact of implementation. After obtaining support from all relevant stakeholders (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e), FC tube implementation centred on the following DFS domains: 1) practice settings (supporting clinics and clinicians), and 2) ecological systems (pathology testing, supply chain and Australian context) (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eOverview of Implementation of the fluoride-citrate (FC) tubes using the Dynamic Sustainability framework (DSF)(\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e\u003cp\u003eIntervention\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTheme\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIssue\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAction / Solution\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eOutcome (as of Dec 2024)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePreanalytical process: OGTT collection tube type\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; Sub-optimal preanalytical process for OGTT leading to missed diagnoses of GDM and missed pregnancies with large-for-gestational age newborn\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026bull; Presented findings to Kimberley Lead Clinicians Forum (LCF) 12th March 2019 and 29th August 2019\u003c/p\u003e\u003cp\u003e\u0026bull; Excess Greiner Bio One FC Tubes from ORCHID Study offered for use for OGTT\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026bull; Kimberley LCF approved FC tube use for all pregnancy OGTTs in Kimberley ACCHO and WACHS clinics serviced by KAMS clinicians (Sep 2019)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLaboratory process\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; FLOX tubes only accepted by local pathology providers\u003c/p\u003e\u003cp\u003e\u0026bull; Laboratory information system (LIS) did not recognise FC tubes as a tube type\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026bull; Presented findings to Statewide public pathology service\u003c/p\u003e\u003cp\u003e\u0026bull; Discussed logistics with Kimberley Statewide public pathology service laboratory managers\u003c/p\u003e\u003cp\u003e\u0026bull; FC tube stamp made to record tube type on pathology request form to track tube usage\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026bull; FC tube approved for glucose measures by Statewide public pathology service Special Biochemistry department, with FC tubes to be run on auto analyser as FLOX tube type\u003c/p\u003e\u003cp\u003e\u0026bull; Clinics needed to supply FC tubes\u003c/p\u003e\u003cp\u003e\u0026bull; Unresolved: FC tubes still recorded as FLOX on LIS\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eImpact on GDM incidence\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; Concerns regarding impact of change of tube type on GDM incidence\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026bull; Kimberley LCF requested ORCHID Study team audit implementation\u003c/p\u003e\u003cp\u003e\u0026bull; Regular contact between ORCHID Study team and Kimberley clinicians to address any concerns raised (see Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e\u003cp\u003e\u0026bull; Head of Department, WACHS Obstetrics and Gynaecology \u0026ndash; Kimberley consulted to help guide interpretation of borderline OGTT results\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026bull; Audit findings regularly communicated back to LCF\u003c/p\u003e\u003cp\u003e\u0026bull; 2.7-fold increase in GDM T2 v T1\u003c/p\u003e\u003cp\u003e\u0026bull; 6.0-fold increase in pharmaceutical use for women diagnosed with GDM\u003c/p\u003e\u003cp\u003e\u0026bull; Over diagnosis concerns addressed: e.g. reassured by evaluation of abnormal glycated haemoglobin at first presentation\u003c/p\u003e\u003cp\u003e\u0026bull; Induction concerns addressed: consultation with Midwife \u0026amp; Obstetrician \u0026ldquo;comfortable\u0026rdquo; with inducing women without pharmaceutical intervention at 40-weeks gestation\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePractice setting (context)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eTheme\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cb\u003eIssue\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cb\u003eAction / Solution\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cb\u003eOutcome (as of Dec 2024)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eClinic systems and training\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; No regional policy for using FC tubes\u003c/p\u003e\u003cp\u003e\u0026bull; Lack of Kimberley clinician knowledge of impact of glycolysis on glucose measures\u003c/p\u003e\u003cp\u003e\u0026bull; High turnover of clinical staff\u003c/p\u003e\u003cp\u003e\u0026bull; Clinician role responsible for OGTT collection varied between clinics\u003c/p\u003e\u003cp\u003e\u0026bull; Increased tube inversion requirements: manufacturer instructions are to invert FC tubes ten times immediately post collection versus eight to ten times for FLOX tubes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026bull; Aboriginal researcher (ES), KAMS management and remote support staff developed a policy document for KAMS\u003c/p\u003e\u003cp\u003e\u0026bull; Policy document endorsed by all the other Kimberley ACCHOs and added to KAMS induction for remote clinicians\u003c/p\u003e\u003cp\u003e\u0026bull; Developed practical resources: implementation support letter, brochure, clinic poster, FC Mix stamp for Statewide public pathology service request form, educational video by Aboriginal researcher (ES)\u003c/p\u003e\u003cp\u003e\u0026bull; Identified management and clinic staff to champion change\u003c/p\u003e\u003cp\u003e\u0026bull; Directory of contacts for support staff and trained staff\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026bull; KAMS PDSA \u0026amp; Action Plan\u003c/p\u003e\u003cp\u003e\u0026bull; Policy document used by all Kimberley ACCHOs\u003c/p\u003e\u003cp\u003e\u0026bull; Audit of request forms from first month post implementation showed all OGTTs conducted used FC tubes\u003c/p\u003e\u003cp\u003e\u0026bull; Clinicians could access tubes as required\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLogistics: clinics\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; Statewide public pathology service normally provides collection tubes but stipulated that clinics will need to provide FC tubes\u003c/p\u003e\u003cp\u003e\u0026bull; Transparent tube labels difficult to read\u003c/p\u003e\u003cp\u003e\u0026bull; KAMS clinicians service two Remote Area Clinics under WACHS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026bull; Consulted KAMS store and estimated the number of pregnancy OGTT each year per clinic, developed tube distribution list and established internal ordering system\u003c/p\u003e\u003cp\u003e\u0026bull; Provided self-adhesive labels for clinics without label printer\u003c/p\u003e\u003cp\u003e\u0026bull; Updated process for KAMS stores to supply FC tubes to WACHS Remote Area Clinics via visiting KAMS clinicians\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026bull; ACCHO \u0026amp; WACHS Remote Area Clinics received the appropriate number of FC tubes\u003c/p\u003e\u003cp\u003e\u0026bull; 12-month supply of FC tubes to a WACHS town clinic\u003c/p\u003e\u003cp\u003e\u0026bull; KAMS store added reordering of FC tubes to their internal order form\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eEcological System\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eTheme\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cb\u003eIssue\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cb\u003eAction / Solution\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cb\u003eOutcome (as of Dec 2023)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePathology laboratory\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; Locum staff unawareness of local Kimberley policy led to rejection of FC tubes at point of receipt\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026bull; Clinic staff advised ORCHID study who liaised with pathology provider\u003c/p\u003e\u003cp\u003e\u0026bull; Consulted with Statewide public pathology service local and regional laboratory managers and Special Biochemistry Department\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026bull; Memorandum sent to all Statewide public pathology service staff to accept FC tubes for remote sites from Clinical Biochemistry Scientist in Charge\u003c/p\u003e\u003cp\u003e\u0026bull; Improvement of locum staff awareness of use of tubes for OGTT in Kimberley region\u003c/p\u003e\u003cp\u003e\u0026bull; Added to Statewide public pathology service Test Directory as an Alternative Container 3rd April 2024\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSupply chain\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; FC tubes not stocked in Australia and the Kimberley region was the only Australian location using FC tubes for routine clinical practice, since 2019.\u003c/p\u003e\u003cp\u003e\u0026bull; Tube expiry 12-months from manufacture \u0026ndash; delays due to shipping reduced shelf life on receipt (range 201 to 311 days)\u003c/p\u003e\u003cp\u003e\u0026bull; Distributor challenges with ordering from international manufacturer\u003c/p\u003e\u003cp\u003e\u0026bull; Market forces: COVID-19 increased shipping delays and impacted on resources e.g., citrate, reduced availability of tubes. This led to gaps between batch lot expiry and arrival of new batch\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026bull; Annual minimum order 3-months before batch lot expiry\u003c/p\u003e\u003cp\u003e\u0026bull; Delivery via airfreight (versus shipping container)\u003c/p\u003e\u003cp\u003e\u0026bull; ORCHID study provided excess tubes to KAMS\u003c/p\u003e\u003cp\u003e\u0026bull; Development of recommendations for alternate strategies to minimise glycolysis to cover gap in FC tube availability \u0026ndash; emailed to Kimberley ACCHOs\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026bull; Minimum order size of 1200 tubes led to unnecessary high cost and waste (~\u0026thinsp;50%)\u003c/p\u003e\u003cp\u003e\u0026bull; Temporary return to use of FLOX tubes in 2022 (three months delay)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAlignment with national guidelines\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; ADIPS \u0026ndash; no specification for OGTT preanalytical process in 2014 guideline update following endorsement of HAPO criteria\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026bull; Members of the ORCHID Study team joined RCPA \u0026amp; AACB Preanalytical Glucose Working Group\u003c/p\u003e\u003cp\u003e\u0026bull; Advocated for endorsement of FC tubes for use Australia wide, including presentations at state, national and international conferences\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026bull; Increased awareness of the impact of glycolysis on OGTT results\u003c/p\u003e\u003cp\u003e\u0026bull; Review article by members of Preanalytical Glucose Working Group recommends FC tubes for remote locations\u003c/p\u003e\u003cp\u003e\u0026bull; Under Review: ADIPS to include specification to address glycolysis\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003eAACB\u0026thinsp;=\u0026thinsp;Australasian Association of Clinical Biochemistry and Laboratory Medicine; ACCHO\u0026thinsp;=\u0026thinsp;Aboriginal Community Controlled Health Organisation; ADIPS\u0026thinsp;=\u0026thinsp;Australasian Diabetes in Pregnancy Society; FLOX\u0026thinsp;=\u0026thinsp;fluoride oxalate; KAMS\u0026thinsp;=\u0026thinsp;Kimberley Aboriginal Medical Services; PDSA\u0026thinsp;=\u0026thinsp;Plan Do Study Act; OGTT\u0026thinsp;=\u0026thinsp;oral glucose tolerance test; ORCHID\u0026thinsp;=\u0026thinsp;Optimisation of screening and management of diabetes in pregnancy study; RCPA\u0026thinsp;=\u0026thinsp;Royal College of Pathologists Australasia; WACHS\u0026thinsp;=\u0026thinsp;Western Australian\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eORCHID Study team stakeholder engagement before, during and after implementation of FC tubes\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEngagement Type\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eWho\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eForums / group sessions\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; Kimberley Lead Clinicians Forum every 3\u0026ndash;6 months\u003c/p\u003e\u003cp\u003e\u0026bull; KAHPF Kimberley Maternal and Child Health Workshops and Forums\u003c/p\u003e\u003cp\u003e\u0026bull; KAMS Board\u003c/p\u003e\u003cp\u003e\u0026bull; KAMS Remote Services Team\u003c/p\u003e\u003cp\u003e\u0026bull; ACCHO clinic in-services\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEmail / phone call (individual basis)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026bull; Midwives, at first use and ad hoc to address issues\u003c/p\u003e\u003cp\u003e\u0026bull; Stores, at order and receipt\u003c/p\u003e\u003cp\u003e\u0026bull; Clinics, ad hoc including at order and receipt and stocktake\u003c/p\u003e\u003cp\u003e\u0026bull; Pathology, ad hoc to address issues\u003c/p\u003e\u003cp\u003e\u0026bull; Distributor, at order and receipt\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003eKAHPF\u0026thinsp;=\u0026thinsp;Kimberley Aboriginal Health Planning Forum; KAMS\u0026thinsp;=\u0026thinsp;Kimberley Aboriginal Medical Service; ACCHO\u0026thinsp;=\u0026thinsp;Aboriginal Community Controlled Health Organisation\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\n\u003ch3\u003ePractice setting: Supporting clinics and clinicians\u003c/h3\u003e\n\u003cp\u003eTo support sustainable implementation, we developed a PDSA Plan as per KAMS continuous quality improvement processes. This included creating a new policy document, resources and providing inductions for new KAMS remote clinicians (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, Clinic systems and training). The ORCHID team provided prompt responses to clinicians regarding use of FC tubes and concerns regarding a perceived GDM over-diagnosis (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, Impact on GDM incidence). Initial concerns included increased burden of managing GDM for women and clinics, associated lack of resources (e.g., patient blood glucose meters) and potential for increased interventions at birth (e.g., induced labour).\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eHow many have we got on the books now, like 55 I think, there\u0026rsquo;s 10 diabetics. \u0026hellip; Well, that\u0026rsquo;s what I\u0026rsquo;m saying. Because I rang her [ORCHID Co-Lead] and said, \u0026ldquo;Are you sure we\u0026rsquo;re not over diagnosing?\u0026rdquo; And she goes, \u0026ldquo;Well, look at the profiles\u0026rdquo;, and they\u0026rsquo;re all up. (Midwife)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eRegular updates were provided to all stakeholders via newsletters, in-services, webinars and plain language statements for ORCHID study publications, with links provided to all documents on the KAMS website (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, Impact on GDM incidence). Over time, clinicians became more confident in the glucose measurements using FC tubes.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eBecause when we were doing the ORCHID study and we were using the different tubes [FLOX] to the ones that we currently use, there were women who I would put money on would have had GDM who then did a negative test, but later on had a macrocosmic baby or other things, and you\u0026rsquo;re like, \u0026ldquo;No, I\u0026rsquo;m sure she should have had GDM.\u0026rdquo; I must admit I feel that a lot less now that we\u0026rsquo;re using the different tubes [FC]. There were women we were [not] picking up who I highly suspect had GDM and we\u0026rsquo;re picking them up now. So, I have a lot more confidence in the test now than I did before. (General Practitioner Obstetrician)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eClinicians reported the need for specific recommendations for interpretation of borderline results from FLOX or FC tubes and the importance for interpretation of results as part of a complete clinical picture, including self-blood glucose monitoring profiles.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eJust to write down something generally about the fluoride citrate tubes with the range and to how to interpret such an accurate tube, rather than old one [FLOX]. (Midwife)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eImpact of the Intervention\u003c/h2\u003e\u003cp\u003eOf 829 records audited as eligible for OGTT\u0026thinsp;\u0026ge;\u0026thinsp;24-weeks\u0026rsquo; gestation, 379 had complete OGTT results on file and were included for analysis (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Another 53 women who had attempted an OGTT but were excluded (11 no recorded glucose measures, 12 disparate tube type, 30 incomplete, Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The remaining 397 (47.9%) with no record of attempting an OGTT were included for comparison as the \u0026lsquo;No OGTT\u0026rsquo; group. Other than propensity to overweight (29.3% v 20.7%, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.007) there were no statistically significant differences in baseline maternal characteristics between women who did and did not attempt an OGTT at or after 24-weeks\u0026rsquo; gestation (data not shown). There were also no statistically significant differences in baseline maternal characteristics for women with complete OGTT data in the T1 versus T2 period (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eMaternal characteristics of women stratified by OGTT completion in the T1 or T2 periods\u003csup\u003eƗ\u003c/sup\u003e\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMaternal characteristics\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNo OGTT\u003c/p\u003e\u003cp\u003e(T1 \u0026amp; T2)\u003c/p\u003e\u003cp\u003e\u003cem\u003eN\u003c/em\u003e\u0026thinsp;=\u0026thinsp;397\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eT1 (FLOX)\u003c/p\u003e\u003cp\u003e\u003cem\u003eN\u003c/em\u003e\u0026thinsp;=\u0026thinsp;195\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eT2 (FC)\u003c/p\u003e\u003cp\u003e\u003cem\u003eN\u0026thinsp;=\u003c/em\u003e\u0026thinsp;184\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eP-value (T1 v T2)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e25\u0026thinsp;\u0026plusmn;\u0026thinsp;6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e25\u0026thinsp;\u0026plusmn;\u0026thinsp;6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e26\u0026thinsp;\u0026plusmn;\u0026thinsp;6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.374\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAboriginal and/or Torres Strait Islander\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e384 (96.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e186 (95.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e175 (95.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.900\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBooking body mass index (BMI, kg/m\u003csup\u003e2\u003c/sup\u003e)\u003csup\u003eǂ\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e25.3\u0026thinsp;\u0026plusmn;\u0026thinsp;6.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e26.4\u0026thinsp;\u0026plusmn;\u0026thinsp;6.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e26.9\u0026thinsp;\u0026plusmn;\u0026thinsp;6.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.452\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBooking BMI category\u003csup\u003eǂ\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUnderweight (\u0026lt;\u0026thinsp;18.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e51 (13.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e18 (9.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e11 (6.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHealthy weight (18.5 to \u0026lt;\u0026thinsp;25.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e154 (40.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e69 (35.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e71 (38.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOverweight (25.0 to \u0026lt;\u0026thinsp;30.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e79 (20.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e58 (29.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e53 (28.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eObese (\u0026ge;\u0026thinsp;30.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e97 (25.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e50 (25.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e49 (26.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.651\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eParity (prior delivery\u0026thinsp;\u0026ge;\u0026thinsp;20-weeks)\u0026thinsp;\u0026ge;\u0026thinsp;1\u003csup\u003e\u0026sect;\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e240 (67.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e126 (66.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e109 (61.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.381\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrevious GDM\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e19 (4.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8 (4.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e10 (5.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.542\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFamily history of diabetes\u003csup\u003e\u0026para;\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e76 (19.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e42 (21.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e43 (23.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.669\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAny antenatal smoking\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e137 (34.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e56 (28.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e59 (32.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.479\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eOGTT\u0026thinsp;=\u0026thinsp;75 g oral glucose tolerance test; FLOX\u0026thinsp;=\u0026thinsp;fluoride-oxalate tube; FC\u0026thinsp;=\u0026thinsp;fluoride-citrate tube.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003e\u003csup\u003eƗ\u003c/sup\u003eT1 time period before implementation of FC tubes (OGTT collection between 01/09/2017 and 31/08/2019); T2 time period after implementation of FC tubes (OGTT collection between 01/10/2019 and 30/09/2021). Women designated No OGTT (no evidence of OGTT completion nor attempt) were assigned to the T1 or T2 period based on the date at 28\u003csup\u003e+\u0026thinsp;6\u003c/sup\u003e-weeks gestation.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003e\u003csup\u003eǂ\u003c/sup\u003eBooking BMI is maternal weight in kilograms measured at booking antenatal visit divided by the square of maternal height in metres. BMI data only available for 381 (No OGTT) antenatal records.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003e\u003csup\u003e\u0026sect;\u003c/sup\u003eParity data only available for 343 (No OGTT), 191 (T1), and 177 (T2) antenatal records.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003e\u003csup\u003e\u0026para;\u003c/sup\u003eFamily history of diabetes includes women with a first-degree relative with type 1 or type 2 diabetes or history of GDM.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eData includes 776 women who attended for antenatal care at a Kimberley Aboriginal Community Controlled Health Organisation; 397 with no evidence of OGTT completion nor attempt and 379 with complete OGTT at or after 24-weeks gestation in the T1 or T2 period. Data are mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation for continuous variables and number and proportion (%) of T1 or T2 cohort for categorical variables. Two-sided t-test \u003cem\u003eP\u003c/em\u003e-value reported for comparison between T1 and T2 groups for continuous data and Pearson chi-square test \u003cem\u003eP\u003c/em\u003e-value reported for comparison between T1 and T2 groups for categorical data.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eWomen in each time period tended to have their OGTT at 28-weeks\u0026rsquo; gestation (Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e). As expected, mean plasma glucose at all three OGTT time-points was 0.7 to 0.8 mmol/L higher in the T2 period compared to the T1 period (Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e). Using ADIPS 2014 criteria there was a 2.8-fold increase in GDM diagnoses with FC tubes compared to FLOX tubes. This difference was largely due to increased detection at the fasting sample (78.1% v 39.3% of GDM cases, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.001). Using ADIPS 2025 criteria for T2 (FC tubes), the GDM diagnosis would only increase 1.9-fold compared to T1 (FLOX tubes).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eOGTT and management outcomes for women using ADIPS-2014 (T1 and T2) and ADIPS-2025 (T2\u003csup\u003eƗ\u003c/sup\u003e) cut-points\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOGTT\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eT1\u003csup\u003eƗ\u003c/sup\u003e\u003c/p\u003e\u003cp\u003e(FLOX ADIPS 2014)\u003c/p\u003e\u003cp\u003e\u003cem\u003eN\u003c/em\u003e\u0026thinsp;=\u0026thinsp;195\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eT2\u003csup\u003eƗ\u003c/sup\u003e\u003c/p\u003e\u003cp\u003e(FC ADIPS 2014)\u003c/p\u003e\u003cp\u003e\u003cem\u003eN\u0026thinsp;=\u003c/em\u003e\u0026thinsp;184\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e\u003cp\u003eT1\u003csup\u003eƗ\u003c/sup\u003e v T2\u003csup\u003eƗ\u003c/sup\u003e\u003c/p\u003e\u003cp\u003e(ADIPS 2014)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eT2\u003csup\u003eƗ\u003c/sup\u003e\u003c/p\u003e\u003cp\u003e(FC ADIPS 2025)\u003c/p\u003e\u003cp\u003e\u003cem\u003eN\u0026thinsp;=\u003c/em\u003e\u0026thinsp;184\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e\u003cp\u003eT1\u003csup\u003eƗ\u003c/sup\u003e v T2\u003csup\u003eƗ\u003c/sup\u003e\u003c/p\u003e\u003cp\u003e(FC ADIPS 2025)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGestational age at OGTT (weeks)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e28.3\u0026thinsp;\u0026plusmn;\u0026thinsp;2.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e28.2\u0026thinsp;\u0026plusmn;\u0026thinsp;2.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.537\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFPG (mmol/L)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4.2\u0026thinsp;\u0026plusmn;\u0026thinsp;0.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4.9\u0026thinsp;\u0026plusmn;\u0026thinsp;0.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e1h-PG (mmol/L)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e7.3\u0026thinsp;\u0026plusmn;\u0026thinsp;1.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8.1\u0026thinsp;\u0026plusmn;\u0026thinsp;2.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e2h-PG (mmol/L)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6.1\u0026thinsp;\u0026plusmn;\u0026thinsp;1.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e6.9\u0026thinsp;\u0026plusmn;\u0026thinsp;2.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"6\" nameend=\"c6\" namest=\"c1\"\u003e\u003cp\u003eNumber above diagnostic threshold at each sample:\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFPG\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e11 (5.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e57 (31.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e36 (19.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e1h-PG\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e16 (8.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e29 (15.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.023\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e19 (10.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0.476\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e2h-PG\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14 (7.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e26 (14.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.028\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e22 (12.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0.113\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"6\" nameend=\"c6\" namest=\"c1\"\u003e\u003cp\u003eCumulative number diagnosed with GDM:\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAt FPG sample\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e11 (5.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e57 (31.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e36 (19.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAt FPG \u0026amp; 1h-PG sample\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e25 (12.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e69 (37.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e44 (23.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAt FPG, 1h- and 2h-PG sample\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e28 (14.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e73 (39.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e50 (27.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"6\" nameend=\"c6\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eAntenatal management of hyperglycaemia\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo GDM: standard antenatal care\u003csup\u003eǂ\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e167 (85.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e109 (59.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e134 (72.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGDM: no management recorded\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 (2.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (1.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e2 (1.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGDM: non-pharmacological intervention\u003csup\u003e\u0026sect;\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e18 (9.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e39 (21.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e20 (10.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGDM: pharmacological intervention\u003csup\u003e\u0026para;\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 (2.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e33 (17.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e28 (15.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"6\"\u003eOGTT\u0026thinsp;=\u0026thinsp;75 g oral glucose tolerance test; FLOX\u0026thinsp;=\u0026thinsp;fluoride-oxalate tube; FC\u0026thinsp;=\u0026thinsp;fluoride-citrate tube; FPG\u0026thinsp;=\u0026thinsp;fasting plasma glucose; PG\u0026thinsp;=\u0026thinsp;plasma glucose; GDM based on Australasian Diabetes in Pregnancy Society (ADIPS) 2014 or 2024 definition as indicated. ADIPS 2014 GDM defined as one or more PG value equal to or above the following thresholds: FPG 5.1 mmol/L, 1h-PG 10.0 mmol/L, 2h-PG 8.5 mmol/L. ADIPS 2025 GDM defined as one or more PG value equal to or above the following thresholds: FPG 5.3 mmol/L, 1h-PG 10.6 mmol/L, 2h-PG 9.0 mmol/L.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"6\"\u003e\u003csup\u003eƗ\u003c/sup\u003eT1 time period before implementation of FC tubes (OGTT collection between 01/09/2017 and 31/08/2019); T2 time period after implementation of FC tubes (OGTT collection between 01/10/2019 and 30/09/2021).\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"6\"\u003e\u003csup\u003eǂ\u003c/sup\u003eIn the T2 time period the \u0026lsquo;No GDM\u0026rsquo; group using ADIPS 2025 criteria included 22 pregnancies that did receive intervention based on ADIPS 2014 criteria (18 non-pharmacological intervention; 2 metformin, 2 insulin)\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"6\"\u003e\u003csup\u003e\u0026sect;\u003c/sup\u003eNon-pharmacological intervention group were recommended diet and lifestyle modifications, and/or self-monitoring of blood glucose.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"6\"\u003e\u003csup\u003e\u0026para;\u003c/sup\u003eIn addition to diet and lifestyle modifications, and/or self-monitoring of blood glucose, the pharmacological intervention group were recommended metformin: 5 (T1); 23 (T2); and/or insulin: 0 (T1); 10 (T2).\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"6\"\u003eData includes women who completed OGTT at or after 24-weeks\u0026rsquo; gestation. Data are mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation for continuous variables and number and proportion (%) of T1 or T2 cohort for categorical variables. Two-sided t-test \u003cem\u003eP\u003c/em\u003e-value reported for comparison between groups for continuous data and Pearson chi-square test \u003cem\u003eP\u003c/em\u003e-value reported for comparison between groups for categorical data.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eConcomitant with the increased detection of women with fasting hyperglycaemia, 7-fold more women were recommended for pharmaceutical management (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) in T2 compared to the T1 period (33 (17.9%) v 5 (2.9%), \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.0001). This was also consistent with the reported clinician perception of under-diagnosis of GDM using FLOX tubes.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eI don\u0026rsquo;t think \u0026hellip; we\u0026rsquo;re picking up false positives, but I think we\u0026rsquo;re just picking up those women that were borderline before and now, they\u0026rsquo;re positive. But I do feel like there\u0026rsquo;s enough in their outcomes for us to say, you know, when you look back retrospectively that they were GDM. [General Practitioner Obstetrician]\u003c/p\u003e\u003cp\u003eI think that this [FC] tube is picking up more people on fasting. So those women that we would have suspected had GDM are getting a higher fasting reading, than I feel like the older [FLOX] tubes would have provided. [General Practitioner Obstetrician]\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eMost (84.8%) of the women who required insulin or metformin in the T2 period would still be identified as having GDM using ADIPS 2025 criteria.\u003c/p\u003e\u003cp\u003eAt initial FC tube implementation, clinicians acknowledged that preterm inductions may increase with increased detection of GDM. However, they estimated the impact would likely be minimal as Kimberley Clinical Guidelines only indicate pre-term induction for women with GDM taking insulin or metformin, in the absence of other clinical indications (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). In the subset of women with known birth outcomes there was no statistical difference in total number of inductions (78/192, 40.6% T1 v 84/180, 46.7% T2, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.152), gestational age at induction, nor any other adverse obstetric outcome between the T1 and T2 periods (Supplementary File 3).\u003c/p\u003e\u003cp\u003eNeonatal birth weight and growth-for-gestational-age outcomes were similar between the T1 and T2 periods (3193 g\u0026thinsp;\u0026plusmn;\u0026thinsp;563 v 3185 g\u0026thinsp;\u0026plusmn;\u0026thinsp;569, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.901; LGA: 10.4% v 14.0%, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.286; SGA: 15.1% v 16.8%, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.646, Supplementary File 3). None of the five recorded stillbirths were in pregnancies with GDM; two were for pregnancies that had normoglycemic OGTT and three were for pregnancies with no OGTT performed. There was no statistical difference in any other adverse newborn outcome between T1 and T2 (Supplementary File 3).\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003eEcological system:\u003c/h2\u003e\u003cp\u003ePathology testing\u003c/p\u003e\u003cp\u003eMost barriers to implementation were encountered when updating relevant pathology testing systems to incorporate FC tubes. The Statewide public pathology service supply Kimberley ACCHOs with the Royal College of Pathologists Australasia recommended blood collection tubes for the tests they perform. While they would not supply FC tubes, they agreed to accept them for glucose measures in the Kimberley region. As FC tube acceptance was not initially reflected in the online test directory, staff turnover increased the risk of FC tubes being rejected at specimen reception. For example, during the audit of medical records one patient attempted the OGTT but was unable to continue. The fasting sample was then rejected by pathology.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eWe have had a change of staff in [Town A] and they queried the use of FC mix tubes for glucose analysis on our analysers and reporting of these patient results. After talking with the few resident staff and [Pathology Manager] in [Town A], I understand that these were in use during the ORCHID study and have continued to be used for [O]GTT's due to the improved results returned. [Acting Medical Scientist in Charge]\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eThis was addressed either by clinicians informing the ORCHID team and team members liaising with the pathology laboratory, or central pathology staff identifying the issue and reminding local Kimberley pathology staff. To rectify this at a system level the ORCHID team communicated all these issues with central pathology staff as they occurred and continued to advocate for collection guidelines to be updated (03/04/2024).\u003c/p\u003e\u003cp\u003eSourcing FC tubes\u003c/p\u003e\u003cp\u003eIn the first year of implementation, excess FC tubes from the ORCHID paired sample study were provided to Kimberley ACCHOs. During the study the ORCHID team experienced delays in receiving tubes from the Australian distributor. The tubes could take up to three months from ordering to arrive in the Kimberley region, reducing shelf life on receipt. Ordering systems were put in place to address these issues (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, Supply chain). As FC tubes are a special item the ORCHID team continue to provide ongoing support.\u003c/p\u003e\u003cp\u003eAnother barrier to procurement was related to the minimum order (1200 tubes), with the Kimberley the only place in Australia using FC tubes for routine clinical practice. Consequently, KAMS would place an annual minimum order and then distribute the tubes to their member services. This also involved establishing an ordering system between KAMS and its member services.\u003c/p\u003e\u003cp\u003eAdvocacy\u003c/p\u003e\u003cp\u003eBroad stakeholder engagement, consultation and advocacy have been embedded in the ORCHID Study. This has included over 50 presentations to Aboriginal community members, health professionals from ACCHOs, WACHS, and Diabetes WA, and laboratory staff. This engagement led to JM and EJ being invited to join the National Harmonisation Glucose Preanalytical Working Party, and preparation of a review paper assessing impact of variations in specimen handling on GDM diagnosis.(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eSupporting changes to Australian blood sample collection protocols to improve accuracy of glucose measurements, the publication will be the cornerstone of the Working Group\u0026rsquo;s position statement for Australian Pathology providers. The Working Group was invited to advise on the revision of Australasian Diabetes in Pregnancy Society consensus guidelines for the testing and diagnosis of GDM in Australia (personal communication). The ORCHID team continues to advocate for FC tubes in OGTTs across Australia, while still supporting KAMS and member services in the use of FC tubes.\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eOur study demonstrated that improved OGTT accuracy though use of FC tubes increased identification of women needing insulin to manage their GDM (10 of 73 FC v 0 of 28 FLOX). Perception that FLOX tubes missed women requiring more intensive management of hyperglycaemia was reflected in clinician views. This increase was likely due to improved detection of fasting hyperglycaemia. In another Australian cohort, fasting plasma glucose\u0026thinsp;\u0026ge;\u0026thinsp;5.3 mmol/L at diagnosis was an independent predictor of insulin therapy.(\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eGDM incidence increased 2.8-fold with FC tubes to 40% of women tested. Initially, clinicians expressed apprehension regarding the impact of potential overdiagnosis of GDM on women. Over time there was recognition of missed GDM diagnoses with FLOX tubes. They were also concerned about increased burden on staff and resources to manage patients with GDM. Remote Kimberley ACCHOs were able to accommodate the increase in workload during the T2 period. However, considering remote health workforce turnover and retention issues,(\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e) we cannot comment on long-term sustainability.\u003c/p\u003e\u003cp\u003eThe recent shift to new elevated GDM diagnostic criteria in Australia would significantly reduce workload in the Kimberley (28% v 40% GDM cases of those tested) while still identifying most (84%) of the women who required more intensive pharmaceutical management. There is ongoing debate on GDM screening and balancing benefit and harm of treatment.(\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e) This includes concerns that management of women with mild hyperglycaemia may not improve birth outcomes.(\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e) Consequently, GDM diagnosis in these women may cause unnecessary psychological harm, including feelings of shock, distress, guilt, shame, stigma, fear and anxiety.(\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eOnly one other jurisdiction in Australia has reported on the impact of addressing preanalytical glycolysis in OGTT samples. The Australian Capital Territory (ACT) Pathology implemented rapid centrifugation of FLOX tubes in 2017.(\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e, \u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e) The 2.8-fold increase in GDM in the Kimberley was significantly higher than the 1.4- to 1.8-fold increase reported in the ACT population after addressing glycolysis. Several factors may explain these findings: differences in remoteness leading to more significant delays to sample processing; differences in models of care (antenatal and GDM management) and GDM risk; and potential positive bias in plasma glucose when using FC tubes.(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e) In the absence of a definitive explanation for this variation in bias, some Australian groups have recommended caution before adopting FC tubes.(\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e, \u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e). Robust studies directly comparing FC tubes to the HAPO ice-slurry preanalytical protocol may determine if a post-analytical correction factor is required.\u003c/p\u003e\u003cp\u003eEarly in FC tube implementation, clinicians also raised concerns about potential increased intervention at birth. In Australia, inductions of labour have increased over the past 20 years to 34% of deliveries.(\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e) Most Australian women who have experienced induction of labour express a desire to avoid induction in future pregnancies.(\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e) The total number of inductions of labour remained similar between time periods. Notably, five stillbirths were recorded during the entire audit, but none were for women managed for GDM.\u003c/p\u003e\u003cp\u003eMost of the barriers to FC tube implementation were at the ecological system level.(\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e) Supply chain issues, cost, lack of formal peak body endorsement and pathology laboratory staff turnover impacted FC tube implementation. Formal Australasian Association of Clinical Biochemistry and Laboratory Medicine, and Royal College of Pathologists Australasia recommendation of FC tubes should increase local demand. This would likely mitigate supply and wastage issues by encouraging local stock distribution, smaller minimum order size and reduced delivery times. There have been no formal reports of barriers to accessing FC tubes in countries that recommend these tubes,(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e) other than during global tube shortages in the COVID-19 pandemic.(\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e) However, it should be noted that all these jurisdictions are proximal to FC tube manufacturers compared to Australia.\u003c/p\u003e\u003cp\u003eThis observational study had some limitations. While some remote WACHS sites also implemented FC tubes in 2019 they were unable to be included as we did not have access to WACHS data. Qualitative interviews were designed to explore clinician experiences of the pregnancy OGTT in general and did not include direct questions about FC tube use; interviewees raised these observations without prompting. These quantitative and qualitative data were collected retrospectively. As the study was a pragmatic evaluation of impact of FC tube implementation on GDM diagnosis and clinic workload, it was not powered to detect changes in obstetric and neonatal outcomes. However, no significant difference in LGA and SGA frequency was observed in the larger ACT cohort study comparing delayed versus rapid centrifugation (\u003cem\u003eN\u003c/em\u003e:8035 v 7686; LGA 10.1% v 10.7%, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05; SGA 11.3% v 11.2%, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05).(\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e) Larger cohorts with detailed assessment of glycaemic management are required to evaluate whether increased management of GDM with the use of FC tubes translate to improved birth outcomes.\u003c/p\u003e\u003cp\u003eThe ORCHID study had been active in the Kimberley region for five years prior to FC tube implementation. High staff turnover of clinic staff and subsequent institutional amnesia was factored into the implementation of FC tubes. This was addressed through regular communication with clinic staff, including in-services to antenatal clinicians on ORCHID Study findings. We are unable to assess the impact of enhanced clinician awareness of GDM and preanalytical glycolysis on antenatal care between time periods as separate from the impact of using FC tubes.\u003c/p\u003e\u003cp\u003eAnother important study limitation is the low OGTT completion (~\u0026thinsp;50%) in both time periods. This is similar to previous findings for rural and remote Australian settings.(\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e) The T2 period coincided with the COVID-19 pandemic. Pragmatic guidelines to triage to full OGTT based on fasting plasma glucose\u0026thinsp;\u0026ge;\u0026thinsp;4.7 mmol/L may account for the slight increase in incomplete OGTT (10, T1 v 20, T2).(\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e) It is also possible that the OGTT was completed at a private pathology provider or WACHS clinic, with results not shared to the ACCHO electronic medical record. However, the study team reviewed the shared My Health Record (when available), progress notes and communications between shared care services for any record of OGTT completion. Other than propensity to overweight there were no differences in maternal characteristics between women who did and did not complete an OGTT. It is therefore likely that a significant number of women with GDM are not managed appropriately because they do not complete testing. Other studies suggest low completion is due to poor acceptability of the OGTT.(\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e) Investigation of more acceptable alternative tests is warranted to ensure appropriate antenatal care for this high-risk population.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eImplementation of FC tubes resulted in improved identification of women with GDM requiring pharmaceutical intervention, with no adverse impact on birth outcomes. Findings from this study support the case for Australian stakeholders to formally recommend FC tube use in pregnancy OGTTs for rural, remote and low resource settings. Acknowledging some of the local barriers to implementation of FC tubes described in the Kimberley region, a collective rather than siloed approach will likely improve success.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eACCHOs \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Aboriginal Community Control Health Organisations\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eACT\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Australian Capital Territory\u003c/p\u003e\n\u003cp\u003eADIPS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Australasian Diabetes in Pregnancy Study Groups\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCONSIDER \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Consolidated criteria for strengthening reporting of health research involving Indigenous peoples\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDSF\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Dynamic Sustainability Framework\u003c/p\u003e\n\u003cp\u003eFLOX \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Fluoride-Oxalate (blood collection tube)\u003c/p\u003e\n\u003cp\u003eFC \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Fluoride-Citrate (blood collection tube)\u003c/p\u003e\n\u003cp\u003eGDM \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Gestational Diabetes Mellitus\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eHAPO\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Hyperglycaemia and Adverse Pregnancy Outcomes (study)\u003c/p\u003e\n\u003cp\u003eKAHPF\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Kimberley Aboriginal Health Planning Forum\u003c/p\u003e\n\u003cp\u003eKAMS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Kimberley Aboriginal Medical Services\u003c/p\u003e\n\u003cp\u003eLGA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Large-for-gestational-age newborn\u003c/p\u003e\n\u003cp\u003eOGTT \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Oral Glucose Tolerance Test\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eORCHID Optimisation of Rural Clinical and Haematological Indicators for Diabetes in pregnancy (study; currently: optimisation of screening and management for diabetes in pregnancy study)\u003c/p\u003e\n\u003cp\u003ePDSA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Plan-Do-Study-Act\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eREDCap\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Research Electronic Database Capture\u003c/p\u003e\n\u003cp\u003eStaRI \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Standards for Reporting Implementation Studies\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSGA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Small-for-gestational-age newborn\u003c/p\u003e\n\u003cp\u003eT1\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Time period 1 captures the 24-months prior to FC tube implementation (01/09/2017 – 31/08/2019)\u003c/p\u003e\n\u003cp\u003eT2\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Time period 2 captures the 24-months post-FC tube implementation (01/10/2019 – 30/09/2021)\u003c/p\u003e\n\u003cp\u003eWA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Western Australia\u003c/p\u003e\n\u003cp\u003eWACHS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Western Australian Country Health Service\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eEthics approval and consent to participate\u003c/p\u003e\n\u003cp\u003eThis study adhered to the Declaration of Helsinki. The ORCHID Study was endorsed by the KAHPF Research Subcommittee. Ethics approval was obtained from the Western Australia Aboriginal Health Ethics Committee (Project reference 584) and The University of Western Australia Human Research Ethics Committee (Project reference 2019/RA/4/20/5572). The project aligns with the Australian National Health and Medical Research Council\u0026rsquo;s guidelines for ethical conduct in Aboriginal and Torres Strait Islander Hearth Research.(51)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis study included data from two groups of participants. \u003cu\u003e1. Retrospective clinical audit:\u003c/u\u003e At patient registration Kimberley ACCHOs obtained consent for use of patient deidentified information to improve their clinical care through audits. As Kimberley ACCHOs requested support from the ORCHID Study for the implementation and evaluation of FC tube usage for the purpose of quality improvement, they granted collective consent for the ORCHID study to access relevant patient data. The Western Australian Aboriginal Health Ethics Committee waived requirement for individual informed consent for inclusion of this data in the audit. \u003cu\u003e2. Qualitative semi-structured interviews:\u003c/u\u003e All participants provided informed written consent.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConsent for publication\u003c/p\u003e\n\u003cp\u003eThe Kimberley ACCHOs Lead Clinicians Forum and relevant staff (antenatal clinicians, managers, CEOs) from participating ACCHOs were provided with a full draft of the paper for comment. No changes were requested.\u003c/p\u003e\n\u003cp\u003eData availability\u003c/p\u003e\n\u003cp\u003eData cannot be shared publicly because of the ethical restrictions involved in working with a small population of Aboriginal people in Western Australia. The minimal dataset will be made available upon request for researchers who meet the criteria for access to confidential data. Interested researchers should contact Western Australian Health Ethics Committee at [email protected] and the Kimberley Aboriginal Health Research Alliance at [email protected].\u003c/p\u003e\n\u003cp\u003eCompeting interests\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no conflicts of interest.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFunding\u003c/p\u003e\n\u003cp\u003eResearch reported in this publication was supported by the Medical Research Future Fund under grant number MRFMB000045. The funder had no role in the study design, conduct of the study, analysis, or dissemination of findings.\u003c/p\u003e\n\u003cp\u003eAuthor Contribution\u003c/p\u003e\n\u003cp\u003eES, EJ, LA, and JM conceived the idea of implementing FC tubes and developed the implementation evaluation. ES led this implementation project, supported by JM and EJ. ES, EJ and JM provided individual support and clinic level in-services to participating ACCHOs. EJ and MH collected quantitative data. EJ designed the quantitative database and led the statistical analysis. ES, EJ, AK and JM collected and analysed the qualitative data. The initial draft manuscript was prepared by ES, MH, EJ and JM. All authors contributed to the interpretation of results. All authors participated in reviewing and editing, and gave their approval for the final manuscript.\u003c/p\u003e\n\u003cp\u003eAcknowledgements\u003c/p\u003e\n\u003cp\u003eWe thank and acknowledge all the management and clinical staff of the Kimberley ACCHOs who assisted with the implementation of the FC tubes. Special thanks to Andrea Horvath (Chair of National Preanalytical Glucose Working Group) and Iain Steve Pratt (ORCHID Co-Investigator) for their critical review of the manuscript before submission.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eMetzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, et al. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008;358(19):1991\u0026ndash;2002.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMetzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, et al. 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Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://static1.squarespace.com/static/5b5fbd5b9772ae6ed988525c/t/5d9bfc58e77d8a0f62503e14/1570503770811/kahpf_diabetes_pregnancy.pdf\u003c/span\u003e\u003cspan address=\"https://static1.squarespace.com/static/5b5fbd5b9772ae6ed988525c/t/5d9bfc58e77d8a0f62503e14/1570503770811/kahpf_diabetes_pregnancy.pdf\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 16 July 2025.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHarris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inf. 2009;42(2):377\u0026ndash;81.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNankervis A, McIntyre HD, Moses R, Ross GP, Callaway L, Porter C et al. 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Strict Preanalytical Oral Glucose Tolerance Test Blood Sample Handling Is Essential for Diagnosing Gestational Diabetes Mellitus. Diabetes Care. 2020;43(7):1438\u0026ndash;41.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHutchinson J, Knight-Agarwal CR, Nolan CJ, Davis D. Changes to Gestational Diabetes Mellitus (GDM) Testing and Associations with the GDM Prevalence and Large- and Small-for-Gestational-Age Infants\u0026mdash;An Observational Study in an Australian Jurisdiction, 2012\u0026ndash;2019. Diabetology. 2025;6(6):54.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSong D, Lia M, Hurley JC. Recommended pre-analytical plasma glucose sampling methodology may distort gestational diabetes mellitus prevalence: implications for diagnostic thresholds. Diabet Med. 2019;11:11.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCarey R, Lunt H, Heenan HF, Frampton CM, Florkowski CM. Collection tubes containing citrate stabiliser over-estimate plasma glucose, when compared to other samples undergoing immediate plasma separation. Clin Biochem. 2016;49(18):1406\u0026ndash;11.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eOrmsby SM, Keedle H, Dahlen HG. Womenʼs reflections on induction of labour and birthing interventions and what they would do differently next time: A content analysis. Midwifery. 2025;140:104201.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAmerican Diabetes Association. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 2014;37(Supplement 1):S81\u0026ndash;90.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGosselin RC, Bowyer A, Favaloro EJ, Johnsen JM, Lippi G, Marlar RA, et al. Guidance on the critical shortage of sodium citrate coagulation tubes for hemostasis testing. J Thromb Haemost. 2021;19(11):2857\u0026ndash;61.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKirke AB, Atkinson D, Moore S, Sterry K, Singleton S, Roxburgh C, et al. Diabetes screening in pregnancy failing women in rural Western Australia: An audit of oral glucose tolerance test completion rates. Aust J Rural Health. 2019;27(1):64\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAustralasian Diabetes in Pregnancy Society (ADIPS), the Australian Diabetes Society (ADS), the Australian Diabetes Educators Association (ADEA), Diabetes Australia (DA). Diagnostic Testing for Gestational diabetes mellitus (GDM) during the COVID 19 pandemic: Antenatal and postnatal testing advice. Joint Position Statement. 2020. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.adips.org/documents/COVID-19GDMDiagnosis030420ADIPSADSADEADAforWebsite.pdf\u003c/span\u003e\u003cspan address=\"https://www.adips.org/documents/COVID-19GDMDiagnosis030420ADIPSADSADEADAforWebsite.pdf\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 16 July 2025.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNational Health and Medical Research Council. Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders. Canberra, Online: Commonwealth of Australia. 2018. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.nhmrc.gov.au/about-us/resources/ethical-conduct-research-aboriginal-and-torres-strait-islander-peoples-and-communities\u003c/span\u003e\u003cspan address=\"https://www.nhmrc.gov.au/about-us/resources/ethical-conduct-research-aboriginal-and-torres-strait-islander-peoples-and-communities\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 16 July 2025.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-pregnancy-and-childbirth","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"prch","sideBox":"Learn more about [BMC Pregnancy and Childbirth](http://bmcpregnancychildbirth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/prch/default.aspx","title":"BMC Pregnancy and Childbirth","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Aboriginal health, Gestational Diabetes Mellitus (GDM), Implementation, diabetes in pregnancy, diagnosis, glucose preanalytics, OGTT, fluoride-citrate tube","lastPublishedDoi":"10.21203/rs.3.rs-7316550/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7316550/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground\u003c/b\u003e\u003c/p\u003e\u003cp\u003eAn estimated 62% of gestational diabetes mellitus (GDM) in rural and remote Australia are missed due to preanalytical error in measuring glucose for the oral glucose tolerance test (OGTT). To address diagnostic inequity, Kimberley Aboriginal Community Control Health Organisations (ACCHOs) replaced fluoride-oxalate (FLOX) tubes with fluoride-citrate (FC) tubes that better preserve glucose in all pregnancy OGTTs in 2019. This study describes FC tube implementation and impact on GDM detection and management.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e\u003cp\u003eA mixed methods approach was used. Acceptability, barriers, enablers and resources required to support implementation were assessed using qualitative descriptive approaches. These were mapped to the Dynamic Sustainability Framework domains of practice settings and ecological systems. A retrospective audit of antenatal records for women attending a Kimberley ACCHO (2018\u0026ndash;2021) described maternal characteristics, OGTT (\u0026ge;\u0026thinsp;24-weeks\u0026rsquo; gestation), GDM management, and birth outcomes over 24-months pre- (T1) and post- (T2) FC tube implementation. Outcomes using new Australian 2025 diagnostic criteria were compared to 2014 criteria (T2 only).\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e\u003cp\u003eClinicians\u0026rsquo; initial concerns (increased GDM diagnosis, interventions at birth, low resources) were resolved when they became more confident in FC glucose measurements. The main barriers to implementation were staff turnover, pathology testing systems and supply chain issues. Of 830 eligible women, 378 (45.5%) completed an OGTT within the audit periods: 196 T1 (FLOX); 182 T2 (FC). Glucose at all OGTT time-points was 0.7 to 0.8 mmol/L higher in T2 (v T1). The 2.8-fold increase in GDM with FC tubes was largely due to increased diagnoses at the fasting sample (39.3% v 78.1% of GDM cases, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.001). Seven-fold more women were recommended for pharmaceutical management of hyperglycaemia (2.6% T1 v 17.6% T2, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Neonatal growth-for-gestational-age and induction of labour was similar between T1 and T2. Using new higher OGTT cut-points would reduce GDM diagnoses (27.5% v 40.1%, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001), while identifying 84.4% of women requiring pharmaceutical management.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusions\u003c/b\u003e\u003c/p\u003e\u003cp\u003eCollection of blood into FC tubes improved identification of women requiring pharmaceutical intervention for GDM. There was no adverse impact on birth interventions. A collective approach involving healthcare practices and pathology providers to implement diagnostic strategies that improve OGTT accuracy is urgently required.\u003c/p\u003e","manuscriptTitle":"A mixed methods assessment of implementation of fluoride-citrate tubes for pregnancy oral glucose tolerance tests: glucose stabilisation improves identification of Aboriginal women requiring pharmaceutical intervention for gestational diabetes","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-18 09:19:29","doi":"10.21203/rs.3.rs-7316550/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2025-09-21T06:59:38+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"64144996864588644558433829579078960660","date":"2025-09-18T08:26:30+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-09-11T04:38:01+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-09-09T15:49:26+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-08-22T07:07:07+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-08-21T05:07:34+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Pregnancy and Childbirth","date":"2025-08-21T05:04:02+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-pregnancy-and-childbirth","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"prch","sideBox":"Learn more about [BMC Pregnancy and Childbirth](http://bmcpregnancychildbirth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/prch/default.aspx","title":"BMC Pregnancy and Childbirth","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3e8258ac-502c-438c-bf65-48d6be8ed60f","owner":[],"postedDate":"September 18th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-09-18T09:19:29+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-18 09:19:29","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7316550","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7316550","identity":"rs-7316550","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}