Early Implementation Insights from a Community-Integrated Care Model to Strengthen Type 1 Diabetes Management in Rural Gujarat | 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 Early Implementation Insights from a Community-Integrated Care Model to Strengthen Type 1 Diabetes Management in Rural Gujarat Chandni Parmar, Raj Sutariya, Farjana Memon, Komal Shah, Nita More, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8484082/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Background Type 1 diabetes (T1D) affects over 280,000 children in India, with their average life expectancy being only 29 years compared to 65 years in high-income countries. This is due to gaps in insulin availability, structured education, and systematic follow-up in the national public health system. Though there is an existing NPCDCS for diabetes control, its reach is exclusively for adults. In response, a comprehensive, integrated model for community-based T1D care was developed and piloted within the existing primary health care system in the Sabarkantha district, Gujarat. Objective This model initiative aims to strengthen the management of children/adolescents aged 0–19 years living with T1D. Methods The proposed model was developed & piloted in Sabarkantha district, from January 2024 onwards, leveraging existing primary healthcare infrastructure. It consists of various components, including capacity building of healthcare providers & community, food diary-based dietary monitoring, multi-tiered documentation, role clarification across healthcare cadres, financial support mechanisms, and quarterly specialist consultations. Results Within eight months, the initiative showed measurable improvements. 54% of the participants showed improvement in glycaemic control, 26.6% reduced insulin requirements, and 35% gained weight among those classified as underweight. Additionally, diabetic ketoacidosis-related hospitalisations were reduced by 66%. In terms of healthcare utilization, 48% shifted toward public facilities. Health system indicators documented establishment of a comprehensive district registry with 124 children/adolescents with T1D, standardization of care protocols, enhanced healthcare provider competency in pediatric insulin management, and improved family self-care practices. Financial support mechanisms provided expert consultations, & 44% of beneficiaries managed their insulin from various available funds. Conclusion This proposed Model demonstrates that comprehensive pediatric T1D care is achievable within resource- constrained settings through strategic optimisation of existing resources integration & offers a replicable blueprint for managing T1D conditions in rural and tribal settings. Type 1 diabetes Community-integrated care Implementation research Health system strengthening Gujarat Figures Figure 1 Figure 2 Figure 3 INTRODUCTION T1D is a chronic autoimmune condition characterized by absolute insulin deficiency due to pancreatic beta-cell destruction, requiring lifelong insulin therapy for survival [1]. Worldwide, it is estimated to affect 1.48 million children and adolescents aged 0 to 19 years, while more recently, as of 2024, it was estimated to be 1.8 million living with T1D before reaching 20 years of age [2, 3]. It is pertinent to note & in fact, it is disturbing as India has the world’s heaviest burden of T1D. It has been observed that it hosts the most children living with T1D, currently estimated to be 280,000, roughly 1 in 2,000 Indian children, and cases are rising at an alarming rate of 6.7% annually [2, 4]. Unfortunately, the average life expectancy for a person diagnosed with T1D in India is only 29 years, which highly contrasts with high-income countries, where the remaining life expectancy for a 10-year-old diagnosed with T1D is approximately 65 years. This 36-year mortality gap reflects a large disparity in access to quality diabetes care, insulin availability, and comprehensive management support [2]. Given that T1D cannot be prevented or cured, comprehensive lifelong management strategies are critical for survival and quality of life [3]. Optimal T1D management is complex and multifaceted, requiring multiple daily basal-bolus insulin injections, regular monitoring of blood glucose, dietary regulation, physical activity, psychosocial support, screening for potential complications, and structured patient education [5, 6]. Empirical evidence showed that patient education regarding self-care forms the backbone of diabetes management. However, many children and adolescents living with T1D in India face premature deaths due to a lack of structured, comprehensive, and timely care. [6, 7]. The NPCDCS was launched by the Government of India in 2010 under the National Health Mission to address the rising burden of non-communicable diseases, contributing approximately 60% of all deaths in the country [8]. It is operating through a tiered healthcare delivery system with NCD cells and clinics at national, state, and district levels, to provide services for early diagnosis, treatment, and follow-up of common NCDs, along with provision for free diagnostic and drug services [9]. However, the NPCDCS framework remains predominantly adult-centric with limited specific provisions for T1D management in children and adolescents [10], critical gaps remain across multiple healthcare delivery levels, including a lack of free supply of insulin, syringes, glucose measuring devices and test strips, a lack of structured diabetes education and counselling, inadequately trained healthcare providers (HCPs), and critical deficiencies in screening coverage and technical proficiency among healthcare workers [10, 11]. Beyond insulin availability, T1D management requires comprehensive management, which is largely lacking in existing public health infrastructure [6, 10]. Despite such high priorities, India, like many other low- and middle-income countries, does not have any structured, dedicated national programme for the management of Type 1 diabetes. While some state-level innovations have been documented [10, 12] They remain isolated initiatives rather than a systematic national policy. There is a dire need for a Comprehensive care model for T1D that is implementable within existing health systems and is scalable, replicable, cost-effective and socially viable. Sabarkantha district in Gujarat, particularly its tribal-dominated areas, also reported challenges in these domains. During routine health screening under Mamta Day, in the respective government initiative in maternal and child health, an 11-year-old child undergoing insulin therapy but without regular blood sugar monitoring or dietary advice was found. Apart from that, the absence of a proper registry or recording system and a lack of any systematic follow-up mechanism highlight critical gaps in the management of diabetes care and catalyse the development of a structured initiative program. This context-specific initiative model is primarily thought to be built utilizing existing health system resources, including Community Health Officers, RBSK medical officers, and primary health centers to deliver comprehensive diabetes care without establishing parallel vertical programs. By integrating T1D care within the existing primary healthcare infrastructure and documenting this approach, the initiative generates critical evidence for replicable, scalable solutions that can bridge the gap between policy intent and ground-level implementation, ultimately enhancing comprehensive T1D care across India's diverse geographical, socioeconomic, and cultural landscape. Aim To strengthen Type 1 diabetes care and management among children and adolescents aged 0–19 years with Type 1 diabetes by developing and implementing a comprehensive, community-integrated care model within the existing primary healthcare system in Sabarkantha district, Gujarat. Objectives To systematically identify, map, and register all children and adolescents aged 0–19 years living with T1D in Sabarkantha district, and establish a structured follow-up mechanism within the existing primary healthcare system. To strengthen the capacity of healthcare providers (PHC MO, RBSK team, CHOs) in delivering high-quality, evidence-based T1D care and management through structured training and support. To enhance self-care management capabilities among children and adolescents living with T1D and their caregivers through structured diabetes education, counselling and technical skill training (insulin, glucose monitoring devices, test strips, and dietary guidance). To improve treatment adherence and health outcomes through need-based financial support for economically disadvantaged children and adolescents with Type 1 Diabetes. To document the implementation process, identification strategies, challenges, and outcomes to generate evidence for replicable, scalable T1D care models within India's primary healthcare infrastructure. METHODOLOGY Study Design and Approach This study adopted an implementation research design to develop, pilot, and document a community-integrated T1D initiative model in the Sabarkantha district, Gujarat. Additionally, it focused on implementing the management of T1D within the healthcare system in a manner that does not require establishing a parallel program. Study Setting The initiative model was implemented in Sabarkantha district, Gujarat, with particular focus on tribal-dominated sub-districts, including Khedbrahma, Poshina, and Vijaynagar. Study Duration The initiative model was initiated in early 2024 and is currently ongoing, including all activities, needs assessment, stakeholder engagement and systematic implementation. Study Population and Sampling Children/adolescents aged 0–19 years living with T1D in Sabarkantha district were enrolled. During the initial phase (March-April 2024), 124 children/adolescents were enrolled living with T1D using systematic screening. Sampling Method: Systematic identification strategies were adopted to identify and enroll all eligible participants. This includes multiple complementary approaches such as screening during Mamta Day activities, RBSK school health screening programs, medical record review at healthcare facilities and engagement with private practitioners and CHO home visits. This rigorous, multi-pronged approach ensured that children from remote villages and marginalised communities were not missed. This served as the foundation for a comprehensive registry documenting demographics, clinical information (diagnosis date, insulin regimen, complications), socioeconomic status, financial support eligibility, and applicable PHC/subcentre/healthcare providers. Data Collection and Analysis Data were collected and analyzed across two key components Health outcomes of all initially enrolled children/adolescents – Four indicators were systematically recorded in the district T1D registry: glycemic control, hospitalization due to DKA, nutritional status, insulin dose requirements, type of health care facility utilization & received donor support Implementation processes – Barriers and facilitators were identified through triangulated data sources, including stakeholder observations and feedback mechanisms. Initiative Model Components Various synergistic key components were designed after reviewing the NPCDCS framework, field observations, and family consultations. The detailed conceptual framework of the community-integrated T1D care model is shown in Fig. 1 . 1. Capacity Building of Healthcare Providers (HCPs) : To strengthen the technical skills of HCPs, multi-level training workshops were conducted: District-Level Training : A comprehensive district-level workshop for all medical officers was conducted in March 2024. It covered T1D pathophysiology, insulin types/storage/administration, glucose monitoring and interpretation, hypoglycemia and hyperglycemia management, dietary principles with carbohydrate counting, psychosocial support, and documentation procedures. Training methodology included lectures, case discussions, and practical demonstrations. Field-Level Training : RBSK teams and CHOs received hands-on training by experts online monthly session in insulin injection techniques (dose preparation, site selection and rotation, safe disposal), dietary counselling using locally available foods, carbohydrate counting with household measures, food diary monitoring, warning sign recognition and referral protocols, family counselling and behaviour change communication, standardized home visit protocols, and register maintenance. Ongoing Capacity Building : Continuous support mechanisms included monthly district review meetings for case discussions and feedback, quarterly refresher sessions reinforcing concepts and addressing identified gaps, and a WhatsApp group enabling real-time case discussions, sharing of educational materials, and telemedicine consultations with diabetologists. 2. Capacity Building of Children/Adolescents Living with T1D and Their Caregiver : Structured workshops were organized to enhance self-care and self-management practices among children and adolescents living with T1D and their caregivers: Training on T1D Awareness and Education : Awareness sessions for 124 initial participants by a diabetologist were conducted. It covered T1D fundamentals, the difference between Type 1 & 2 diabetes, lifelong insulin importance, glucose monitoring and interpretation, dietary considerations, hypoglycemia recognition and management, self-care practices (hygiene, foot care, sick day management), psychosocial aspects, and peer support. A participatory approach with experience sharing and Gujarati-language materials facilitated a clearer understanding. Training on Technical Skills : RBSK medical officers conducted weekly visits (Saturdays and outreach days), providing hands-on training in handwashing and site preparation, proper insulin drawing with accurate dosing, site selection with rotation using body diagrams, correct injection angle and speed, post-injection care and disposal, insulin storage, and troubleshooting common problems. Multiple family members received training through demonstration, return demonstration, and corrective feedback until competency was achieved. Ongoing Education : Twice-weekly CHO visits linking dietary advice to glucose readings, facility follow-up visits, quarterly peer support meetings, and simplified information, education, and communication (IEC) materials on festival management and travel supported continuous learning. 3. Dietary Monitoring and Glycemic Control Food Diary Development and Distribution : Structured food diaries were developed in consultation with experts to improve adherence, enhance dietary understanding, enable early detection of glycemic fluctuations, and support better management through regular monitoring and family engagement. Food diaries included sections for daily meal-wise food intake with timing, approximate carbohydrate consumption, insulin doses (type, units, timing), glucose levels (fasting, pre-meal, post-meal), complications (hypoglycemia, illness, physical activity), and remarks for challenges or questions. Families were oriented on the diary's purpose as an empowerment tool, received hypoglycemia IEC materials, trained on accurate completion, taught basic pattern interpretation, and counselled on how documentation supports insulin and meal adjustments. Home-Based Follow-Up : CHOs conducted twice-weekly home visits (Tuesdays and Fridays) reviewing diary entries, providing individualized dietary counselling based on identified trends, assessing adherence and barriers, encouraging continued adherence, and flagging concerns for medical officers. 4. Documentation and Monitoring Systems : Multi-tiered documentation systems were established to ensure comprehensive tracking: Patient Level : Food diaries with daily data and individual health cards documenting clinical parameters, treatment regimen, complications, immunizations, and specialist reports. Sub-Centre Level : CHOs maintained NCD registers with dedicated pediatric T1D sections recording baseline information, home visit findings (post-prandial 2-hour blood sugar levels, counselling provided, issues identified, referrals made, follow-up plans, and visit logs documenting all interactions and advice provided. RBSK Level : Documentation of insulin training and competency assessment, weekly visit progress notes, growth parameters, referrals for complications, and training reinforcement activities. District Level : A centralized, comprehensive registry was proposed with updated monthly captured clinical data, coverage metrics, resource utilization, training participation data, and implementation challenges using a simple Google spreadsheet. Monthly data validation meetings for documentation review and error correction with all stakeholders, and WhatsApp-based real-time reporting for critical issues ensured data quality and program responsiveness. 5. Role Clarification Across Healthcare Cadres : Clear role & responsibility across all levels have been delineated, which reduced duplication and ensured accountability: Families and Caregivers : Responsible for accurate food diary maintenance, insulin schedule adherence, daily glucose monitoring and recording, dietary recommendation compliance, training and follow-up attendance, adverse event reporting, safe insulin storage, safe sharps disposal, and peer support meeting participation. Community Health Officers : Provided dietary support through twice-weekly visits (Tuesdays and Fridays), reviewed food diaries, monitored post-prandial 2-hour blood sugar levels, delivered tailored dietary counseling, assessed adherence and identified barriers, maintained NCD registers, ensured timely follow-up with outreach for missed appointments, and participated in review meetings and refresher training. RBSK Medical Officers : Served as primary insulin training providers, conducted initial hands-on family training, weekly home visits for practice observation and feedback, ensured safe dosing and site rotation, documented training completion and competency achievement, identified and referred complications, and participated in coordination meetings. PHC and CHC Medical Officers : Provided overall clinical oversight, reviewed progress during monthly meetings, adjusted insulin dose as needed, managed acute complications, mobilized resources through NPCDCS, Pradhan Mantri Jan Arogya Yojana (PMJAY), Rogi Kalyan Samiti (RKS), and available donor funds, facilitated specialist referrals and organized quarterly specialist camps, coordinated district-level activities, mentored field staff monthly, maintained the district registry, and generated monthly reports. District Health Authorities : Provided policy support and administrative approvals, coordinated inter-departmental activities, ensured timely budget allocation, monitored program indicators, addressed systemic bottlenecks (staff vacancies, supply gaps), provided feedback and recognition to staff, and documented learning for dissemination and scale-up. 6. Financial Support Mechanisms : PHC and CHC medical officers coordinated access to glucometers and insulin through multiple funding streams, mainly from available government funds. PMJAY provided coverage for eligible families, NPCDCS drug budgets supplied essential medications, and RKS funds supported consumables. Eligibility prioritized below-poverty-line families, families in remote tribal areas, newly diagnosed children, and temporary supply gaps. 7. Specialist Consultation and Peer Support : Quarterly endocrinology consultations were organized at the district hospital with transportation support for families from remote areas. Telemedicine consultations were arranged for routine follow-up, avoiding unnecessary travel while ensuring expert guidance. Peer support meetings facilitated experience sharing and mutual encouragement among families. Ethics approval: This initiative was part of a district health department-led public health program on Type 1 Diabetes care, with administrative approval from the Chief District Health Officer. It involved routine program monitoring and evaluation, using only aggregated, de-identified data without any experimental interventions. The activity posed minimal risk and, in line with national guidelines. Thus, neither Clinical trial registration nor individual consent was required. Key observations/Key findings As the initiative is ongoing, observations/findings are presented as mid-line results in % calculated out of 124 enrolled children/adolescents over eight months of implementation (March-November 2024). The key findings of the initiative model pilot phase are described in Fig. 2 A comprehensive district-wide Type 1 diabetes registry was established in Sabarkantha , enrolling 124 children/adolescents and enabling systematic documentation of clinical and care-related parameters. The registry expanded progressively from an initial cohort of 46 children identified in March–April 2024. Access to essential diabetes care resources improved through coordinated mobilization of multiple funding mechanisms, resulting in enhanced availability of insulin and glucometers. Among enrolled children, 44% received donor-supported insulin & consultation check-up Healthcare utilization shifted toward public facilities, with 48% transitioning to government health services for Type 1 diabetes management. Health system perspective : Targeted capacity-building strengthened healthcare provider’s competency in paediatric T1D management, contributing to a 66% reduction in DKA-related hospitalizations. Patient and caregiver perspective : 26.6% of children achieved reduced daily insulin doses, alongside improved peer support and emotional coping, which shows structured education improved self-care practices and disease understanding Glycaemic Control : 54% showed improvement in their HbA1C in the last 8 months, Nutritional Status : Among children classified as underweight at baseline, 35% children gained sufficient weight to improve their nutritional status category Implementation Challenges Community-integrated T1D care model rollout was successful, though several implementation challenges were faced and required adaptive strategies: Financial Sustainability Concerns To identify & sustain the multiple funding streams to facilitate continuity of care and regular quarterly specialist visits proved challenging. Disruption in the flow of funds influenced the process of disbursement and procurement, sometimes disrupting continuity in the provision of items/medicines. Along with that, maintaining various funding streams increased administrative burdens as it required a volume of documentation associated with those funds. Awareness and Education Barriers Early implementation phase reported resistance from families due to deep-rooted misconceptions about the disease and its treatment. Lack of capacity in the health infrastructure and integration of different stakeholders at different levels in the districts created logistical problems in promoting uniform education for newly enrolled children. Technology and Infrastructure Constraints Implementing telemedicine in tribal areas remained challenging due to poor connectivity. Also, establishing a WhatsApp-based communication network required digital literacy support for some stakeholders. Follow-Up and Reporting Mechanism issues Initially, it was difficult to maintain structured follow-up visits due to the multiple duties of all levels of cadre, as they were dealing with various activities and programs at the same time. Also, home-based care depended on continued motivation and availability of CHO and RBSK teams across geographically dispersed locations. Concurrently ensuring data quality across paper-based food diaries, facility registers, and the electronic district registry required continuous supervision and validation. Gaps in Psychosocial Support : In addressing deeply rooted psychosocial concerns required to build trust with families, there may be a hesitation to share emotional struggles during initial interactions. Organized peer support group meetings proved to be a logistical burden, considering the geographical dispersal of families within the district. Inclusion of psychosocial support within clinical contacts took additional time considering heavy loads of health care providers. These issues were not completely addressed but were instead dealt with through adaptive approaches such as creating buffer stocks to fill gaps, making schedules for rotating visits to cover as many as possible with the same personnel, focusing on priority cases when conditions were limited, and finding acceptable solutions and constantly improving on these practices. The brief Implementation challenges, adopted strategies to overcome the challenges and evidence-based recommendations are illustrated in Fig. 3 . Discussion & Recommendations The Sabarkantha Model proves that a comprehensive and effective pediatric program for T1D can be successfully achieved within existing resources by integrating them into the primary care structure. Emphasis in the Sabarkantha Model has been on multi-level capacity building, financial support mechanisms, and the participatory approach of all stakeholders, including the affected children as well as their caregivers. participation of children and adolescents as equal partners. After just eight months of the implementation of the initiative, results were conclusive and included improved control of diabetes in 54% of children enrolled, a decrease in the rate of admissions due to diabetic ketoacidosis by 66%, and the use of public health care services rising to 48%. In contrast to other models in developed nations relying heavily on expert human resources, advanced technology, and high costs, the Sabarkantha Model demonstrates feasibility and impact through decentralized care, primary health platforms, and community health worker networks operating under constrained resources. The model leverages other innovations from states such as West Bengal and Karnataka, with additional components including structured insulin skills training by RBSK medical officers, regular food diary maintenance, CHO home visits, and multi-source public funding approaches. Unlike programs run or initiated by NGOs and donor agencies, there appears to be a certain viability to implementing these programs within a governmental framework. However, certain limitations are worth consideration. The follow-up duration is only eight months, and thus, it is not possible to state the sustainability and outcomes on a long-term scale. There is no comparison or control district, which is an issue from the perspective of establishing the effectiveness of initiatives, because it is impossible to determine causal relations solely based on this initiative. Furthermore, despite careful enrollment techniques, selection bias may remain, especially when considering children from far-off tribal areas or those from private healthcare facilities only. To make this a successful, self-sustaining program and to implement it on a larger scale, there are some recommendations based on evidence. Firstly, upgradation of service delivery is important. Involves the upgradation of pediatric endocrinology or training existing HCPs at various levels by means of training programs. Upgradation of telemedicine infrastructure, periodic expert consultations into systems, is a very important enabler of accessibility to specialists in geographically remote locations. consultation, telemedicine, and preparation of hub and spoke models of tertiary and district hospitals. Regarding policy considerations, there is a need to formally incorporate OPD and IPD care packages of T1D within PMJAY to provide financial protection. The inclusion of T1D within the larger framework of NPCDCS and the formulation of national guidelines regarding screening, diagnosis, management, and follow-up of T1D would help to formally include T1D indicators in national information systems at a monitoring and accountability level. The priority areas in the development of programs are preparing transitional protocols for adolescents as they shift services into adult care systems and incorporating psychosocial services through screening and counselling. These are fundamental in dealing with psychosocial risks. It is recommended that the research agenda include evaluation studies, cost-effectiveness studies, qualitative work related to families and caregivers, as well as studies related to implementing it in other regions, which would help in evaluating how well it adapts in different geographic regions. Conclusion The Sabarkantha model proves that the art of comprehensive management of T1D can be achieved within the existing framework of public health care systems available in low-resource and tribal areas through strategic optimisation of resources. Capacity building, financial protection, and involvement of the concerned community members will contribute as key observations at the clinical level as well as at the system level, thus providing disciplinary success to the concerned model of care. It offers a replicable blueprint for managing T1D conditions in rural and tribal settings. Declarations Ethical approval This manuscript reports findings from a pilot implementation of initiatives conducted under a routine public health programme and initiated by the District Health Authorities of Sabarkantha, Gujarat. The analysis used de-identified programme data collected during standard care. No additional interventions were performed for research purposes. Thus, formal ethics committee approval was not applicable. The initiative followed the ethical principles of the Declaration of Helsinki and relevant national public health guidelines. Consent to participate Participants were enrolled as part of routine care under the National Programme for Prevention and Control of Non-Communicable Diseases (NPCDCS), and no additional procedures were performed for research purposes. The analysis used de-identified programme data only. In line with the Declaration of Helsinki (2013) and ICMR National Ethical Guidelines (2017), separate informed consent for research participation was not required. Consent to publish No individual-level identifiable data are presented in this manuscript. All data were analysed and reported in an aggregated and anonymised manner; therefore, consent for publication of individual participant data was not applicable. CONFLICTS OF INTEREST: The authors declare no conflicts of interest related to this work. FUNDING STATEMENT: No financial support Author Contribution CP and RS Conceptualise the proposed Model. NM assisted in the monitoring & evaluation of this model in the field. FM have drafted the first draft of the manuscript; KS & TP reviewed & edited the manuscript. All authors have read & approved the final draft of the manuscript. Acknowledgement The authors acknowledge the PHC MO, RBSK team, and CHOs for their dedication to implementing this model. We thank the District Health Administration for administrative help in this process. The authors are grateful to the diabetologists/pediatric endocrinologists who provided consultation/training inputs in this process. The authors thank all those who helped in this process financially by providing insulin/monitoring materials in this effort. And last but not least, we thank all children/adolescents & their caregivers who participated in this intervention model, cooperated in all process and shared their experiences to improve care for others. Data Availability The dataset used for this analysis is the property of the district health authority and was accessed with administrative approval from the District Health Officers. The data were provided in aggregated and de-identified form as part of routine public health program monitoring. References Type 1 Diabetes | International Diabetes Federation. https://idf.org/about-diabetes/types-of-diabetes/type-1-diabetes/. Accessed 28 Dec 2025 Gregory GA, Robinson TIG, Linklater SE, et al (2022) Global incidence, prevalence, and mortality of type 1 diabetes in 2021 with projection to 2040: a modelling study. Lancet Diabetes Endocrinol 10:741–760. https://doi.org/10.1016/S2213-8587(22)00218-2 Home | International Diabetes Federation. https://idf.org/. Accessed 28 Dec 2025 Madhu S V., Shukla P, Kaur T, Dhaliwal RS (2024) Mortality in type 1 diabetes mellitus: A single centre experience from the ICMR – Youth onset diabetes registry in India. Diabetes Res Clin Pract 217:. https://doi.org/10.1016/j.diabres.2024.111868 Ghosh S, Yasmin M, Sen K, et al (2023) Integrated Care for Type 1 Diabetes: The West Bengal Model. Indian J Endocrinol Metab 27:398–403. https://doi.org/10.4103/IJEM.IJEM_124_23 Pihoker C, Forsander G, Fantahun B, et al (2018) ISPAD Clinical Practice Consensus Guidelines 2018: The delivery of ambulatory diabetes care to children and adolescents with diabetes. Pediatr Diabetes 19 Suppl 27:84–104. https://doi.org/10.1111/PEDI.12757 Long-Term Effect of Diabetes and Its Treatment on Cognitive Function. New England Journal of Medicine 356:1842–1852. https://doi.org/10.1056/NEJMOA066397 National Programme for prevention & Control of Cancer, Diabetes, Cardiovascular Diseases & stroke (NPCDCS) :: National Health Mission. https://nhm.gov.in/index1.php?lang=1&level=2&sublinkid=1048&lid=604. Accessed 28 Dec 2025 admin Operational Guidelines for Implementation of National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) for year 2013-17 Operational Guidelines for Implementation of NPCDCS for year 2013-17 Yasmin M, Mukhopadhyay P, Ghosh S (2022) Model of care for Type 1 diabetes in India: Integrated approach for its incorporation in future national health care policy. The Lancet Regional Health - Southeast Asia 3:. https://doi.org/10.1016/j.lansea.2022.05.003 (PDF) Evaluation of National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular disease and Stroke (NPCDCS) in Gandhinagar district, Gujarat 1 2 3. https://www.researchgate.net/publication/337705578_Evaluation_of_National_Programme_for_Prevention_and_Control_of_Cancer_Diabetes_Cardiovascular_disease_and_Stroke_NPCDCS_in_Gandhinagar_district_Gujarat_1_2_3. Accessed 28 Dec 2025 Ghosh S, Yasmin M, Sen K, et al (2023) Integrated Care for Type 1 Diabetes: The West Bengal Model. Indian J Endocrinol Metab 27:398–403. https://doi.org/10.4103/IJEM.IJEM_124_23 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 09 Apr, 2026 Reviews received at journal 08 Apr, 2026 Reviews received at journal 15 Mar, 2026 Reviewers agreed at journal 13 Mar, 2026 Reviewers agreed at journal 05 Mar, 2026 Reviewers invited by journal 03 Mar, 2026 Editor assigned by journal 21 Jan, 2026 Submission checks completed at journal 20 Jan, 2026 First submitted to journal 20 Jan, 2026 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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20:23:05","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8484082/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8484082/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":104207196,"identity":"d99d4227-4552-4f63-a1a1-e1a4724d83f9","added_by":"auto","created_at":"2026-03-09 07:08:04","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":228013,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eConceptual Framework of Community-Integrated T1D Care Model\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8484082/v1/df493679b241a85a11bf5621.jpg"},{"id":104207198,"identity":"02ccc5f3-8cda-4b70-b446-4b144a5b5058","added_by":"auto","created_at":"2026-03-09 07:08:04","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":290171,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eKey Findings of the initiative model pilot phase\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8484082/v1/c8d510d19426f0d445a2c420.jpg"},{"id":104404067,"identity":"e5fe1542-95bf-4e28-a357-a7c86ae568e8","added_by":"auto","created_at":"2026-03-11 12:19:41","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":194999,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eImplementation challenges and evidence-based recommendations\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8484082/v1/3041ab89e3659d875a8e4ea5.jpg"},{"id":104808413,"identity":"320585bb-1908-42ab-8274-e9203eb1fbdc","added_by":"auto","created_at":"2026-03-17 12:37:17","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1831816,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8484082/v1/5b885552-d2ad-446b-bdcb-cbe9f78a0fbd.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Early Implementation Insights from a Community-Integrated Care Model to Strengthen Type 1 Diabetes Management in Rural Gujarat","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eT1D is a chronic autoimmune condition characterized by absolute insulin deficiency due to pancreatic beta-cell destruction, requiring lifelong insulin therapy for survival [1]. Worldwide, it is estimated to affect 1.48\u0026nbsp;million children and adolescents aged 0 to 19 years, while more recently, as of 2024, it was estimated to be 1.8\u0026nbsp;million living with T1D before reaching 20 years of age [2, 3]. It is pertinent to note \u0026amp; in fact, it is disturbing as India has the world’s heaviest burden of T1D. It has been observed that it hosts the most children living with T1D, currently estimated to be 280,000, roughly 1 in 2,000 Indian children, and cases are rising at an alarming rate of 6.7% annually [2, 4]. Unfortunately, the average life expectancy for a person diagnosed with T1D in India is only 29 years, which highly contrasts with high-income countries, where the remaining life expectancy for a 10-year-old diagnosed with T1D is approximately 65 years. This 36-year mortality gap reflects a large disparity in access to quality diabetes care, insulin availability, and comprehensive management support [2]. Given that T1D cannot be prevented or cured, comprehensive lifelong management strategies are critical for survival and quality of life [3]. Optimal T1D management is complex and multifaceted, requiring multiple daily basal-bolus insulin injections, regular monitoring of blood glucose, dietary regulation, physical activity, psychosocial support, screening for potential complications, and structured patient education [5, 6]. Empirical evidence showed that patient education regarding self-care forms the backbone of diabetes management. However, many children and adolescents living with T1D in India face premature deaths due to a lack of structured, comprehensive, and timely care. [6, 7].\u003c/p\u003e \u003cp\u003eThe NPCDCS was launched by the Government of India in 2010 under the National Health Mission to address the rising burden of non-communicable diseases, contributing approximately 60% of all deaths in the country [8]. It is operating through a tiered healthcare delivery system with NCD cells and clinics at national, state, and district levels, to provide services for early diagnosis, treatment, and follow-up of common NCDs, along with provision for free diagnostic and drug services [9]. However, the NPCDCS framework remains predominantly adult-centric with limited specific provisions for T1D management in children and adolescents [10], critical gaps remain across multiple healthcare delivery levels, including a lack of free supply of insulin, syringes, glucose measuring devices and test strips, a lack of structured diabetes education and counselling, inadequately trained healthcare providers (HCPs), and critical deficiencies in screening coverage and technical proficiency among healthcare workers [10, 11]. Beyond insulin availability, T1D management requires comprehensive management, which is largely lacking in existing public health infrastructure [6, 10].\u003c/p\u003e \u003cp\u003eDespite such high priorities, India, like many other low- and middle-income countries, does not have any structured, dedicated national programme for the management of Type 1 diabetes. While some state-level innovations have been documented [10, 12] They remain isolated initiatives rather than a systematic national policy. There is a dire need for a Comprehensive care model for T1D that is implementable within existing health systems and is scalable, replicable, cost-effective and socially viable. Sabarkantha district in Gujarat, particularly its tribal-dominated areas, also reported challenges in these domains. During routine health screening under Mamta Day, in the respective government initiative in maternal and child health, an 11-year-old child undergoing insulin therapy but without regular blood sugar monitoring or dietary advice was found. Apart from that, the absence of a proper registry or recording system and a lack of any systematic follow-up mechanism highlight critical gaps in the management of diabetes care and catalyse the development of a structured initiative program. This context-specific initiative model is primarily thought to be built utilizing existing health system resources, including Community Health Officers, RBSK medical officers, and primary health centers to deliver comprehensive diabetes care without establishing parallel vertical programs. By integrating T1D care within the existing primary healthcare infrastructure and documenting this approach, the initiative generates critical evidence for replicable, scalable solutions that can bridge the gap between policy intent and ground-level implementation, ultimately enhancing comprehensive T1D care across India's diverse geographical, socioeconomic, and cultural landscape.\u003c/p\u003e\n\u003ch3\u003eAim\u003c/h3\u003e\n\u003cp\u003eTo strengthen Type 1 diabetes care and management among children and adolescents aged 0–19 years with Type 1 diabetes by developing and implementing a comprehensive, community-integrated care model within the existing primary healthcare system in Sabarkantha district, Gujarat.\u003c/p\u003e \u003cp\u003e \u003cb\u003eObjectives\u003c/b\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e\u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo systematically identify, map, and register all children and adolescents aged 0–19 years living with T1D in Sabarkantha district, and establish a structured follow-up mechanism within the existing primary healthcare system.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo strengthen the capacity of healthcare providers (PHC MO, RBSK team, CHOs) in delivering high-quality, evidence-based T1D care and management through structured training and support.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo enhance self-care management capabilities among children and adolescents living with T1D and their caregivers through structured diabetes education, counselling and technical skill training (insulin, glucose monitoring devices, test strips, and dietary guidance).\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo improve treatment adherence and health outcomes through need-based financial support for economically disadvantaged children and adolescents with Type 1 Diabetes.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo document the implementation process, identification strategies, challenges, and outcomes to generate evidence for replicable, scalable T1D care models within India's primary healthcare infrastructure.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e"},{"header":"METHODOLOGY","content":"\u003ch2\u003eStudy Design and Approach\u003c/h2\u003e\u003cp\u003eThis study adopted an implementation research design to develop, pilot, and document a community-integrated T1D initiative model in the Sabarkantha district, Gujarat. Additionally, it focused on implementing the management of T1D within the healthcare system in a manner that does not require establishing a parallel program.\u003c/p\u003e\u003ch3\u003eStudy Setting\u003c/h3\u003e\u003cp\u003eThe initiative model was implemented in Sabarkantha district, Gujarat, with particular focus on tribal-dominated sub-districts, including Khedbrahma, Poshina, and Vijaynagar.\u003c/p\u003e\u003ch3\u003eStudy Duration\u003c/h3\u003e\u003cp\u003eThe initiative model was initiated in early 2024 and is currently ongoing, including all activities, needs assessment, stakeholder engagement and systematic implementation.\u003c/p\u003e\u003ch3\u003eStudy Population and Sampling\u003c/h3\u003e\u003cp\u003eChildren/adolescents aged 0–19 years living with T1D in Sabarkantha district were enrolled. During the initial phase (March-April 2024), 124 children/adolescents were enrolled living with T1D using systematic screening.\u003c/p\u003e\u003ch2\u003eSampling Method:\u003c/h2\u003e\u003cp\u003eSystematic identification strategies were adopted to identify and enroll all eligible participants. This includes multiple complementary approaches such as screening during Mamta Day activities, RBSK school health screening programs, medical record review at healthcare facilities and engagement with private practitioners and CHO home visits. This rigorous, multi-pronged approach ensured that children from remote villages and marginalised communities were not missed. This served as the foundation for a comprehensive registry documenting demographics, clinical information (diagnosis date, insulin regimen, complications), socioeconomic status, financial support eligibility, and applicable PHC/subcentre/healthcare providers.\u003c/p\u003e\u003cp\u003e \u003cstrong\u003eData Collection and Analysis\u003c/strong\u003e \u003c/p\u003e\u003cp\u003eData were collected and analyzed across two key components\u003c/p\u003e\u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eHealth outcomes of all initially enrolled children/adolescents\u003c/b\u003e – Four indicators were systematically recorded in the district T1D registry: glycemic control, hospitalization due to DKA, nutritional status, insulin dose requirements, type of health care facility utilization \u0026amp; received donor support\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eImplementation processes\u003c/b\u003e – Barriers and facilitators were identified through triangulated data sources, including stakeholder observations and feedback mechanisms.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e\u003ch3\u003eInitiative Model Components\u003c/h3\u003e\u003cp\u003eVarious synergistic key components were designed after reviewing the NPCDCS framework, field observations, and family consultations. The detailed conceptual framework of the community-integrated T1D care model is shown in Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e \u003cb\u003e1. Capacity Building of Healthcare Providers (HCPs)\u003c/b\u003e: To strengthen the technical skills of HCPs, multi-level training workshops were conducted:\u003c/p\u003e\u003cp\u003e \u003c/p\u003e\u003col style=\"list-style-type:lower-roman;\"\u003e\u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eDistrict-Level Training\u003c/b\u003e: A comprehensive district-level workshop for all medical officers was conducted in March 2024. It covered T1D pathophysiology, insulin types/storage/administration, glucose monitoring and interpretation, hypoglycemia and hyperglycemia management, dietary principles with carbohydrate counting, psychosocial support, and documentation procedures. Training methodology included lectures, case discussions, and practical demonstrations.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eField-Level Training\u003c/b\u003e: RBSK teams and CHOs received hands-on training by experts online monthly session in insulin injection techniques (dose preparation, site selection and rotation, safe disposal), dietary counselling using locally available foods, carbohydrate counting with household measures, food diary monitoring, warning sign recognition and referral protocols, family counselling and behaviour change communication, standardized home visit protocols, and register maintenance.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eOngoing Capacity Building\u003c/b\u003e: Continuous support mechanisms included monthly district review meetings for case discussions and feedback, quarterly refresher sessions reinforcing concepts and addressing identified gaps, and a WhatsApp group enabling real-time case discussions, sharing of educational materials, and telemedicine consultations with diabetologists.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e\u003cp\u003e \u003cb\u003e2. Capacity Building of Children/Adolescents Living with T1D and Their Caregiver\u003c/b\u003e: Structured workshops were organized to enhance self-care and self-management practices among children and adolescents living with T1D and their caregivers:\u003c/p\u003e\u003col style=\"list-style-type:lower-roman;\"\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eTraining on T1D Awareness and Education\u003c/b\u003e: Awareness sessions for 124 initial participants by a diabetologist were conducted. It covered T1D fundamentals, the difference between Type 1 \u0026amp; 2 diabetes, lifelong insulin importance, glucose monitoring and interpretation, dietary considerations, hypoglycemia recognition and management, self-care practices (hygiene, foot care, sick day management), psychosocial aspects, and peer support. A participatory approach with experience sharing and Gujarati-language materials facilitated a clearer understanding.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eTraining on Technical Skills\u003c/b\u003e: RBSK medical officers conducted weekly visits (Saturdays and outreach days), providing hands-on training in handwashing and site preparation, proper insulin drawing with accurate dosing, site selection with rotation using body diagrams, correct injection angle and speed, post-injection care and disposal, insulin storage, and troubleshooting common problems. Multiple family members received training through demonstration, return demonstration, and corrective feedback until competency was achieved.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eOngoing Education\u003c/b\u003e: Twice-weekly CHO visits linking dietary advice to glucose readings, facility follow-up visits, quarterly peer support meetings, and simplified information, education, and communication (IEC) materials on festival management and travel supported continuous learning.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e\u003cp\u003e \u003cb\u003e3. Dietary Monitoring and Glycemic Control\u003c/b\u003e \u003c/p\u003e\u003col style=\"list-style-type:lower-roman;\"\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eFood Diary Development and Distribution\u003c/b\u003e: Structured food diaries were developed in consultation with experts to improve adherence, enhance dietary understanding, enable early detection of glycemic fluctuations, and support better management through regular monitoring and family engagement. Food diaries included sections for daily meal-wise food intake with timing, approximate carbohydrate consumption, insulin doses (type, units, timing), glucose levels (fasting, pre-meal, post-meal), complications (hypoglycemia, illness, physical activity), and remarks for challenges or questions.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eFamilies were oriented on the diary's purpose as an empowerment tool, received hypoglycemia IEC materials, trained on accurate completion, taught basic pattern interpretation, and counselled on how documentation supports insulin and meal adjustments.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eHome-Based Follow-Up\u003c/b\u003e: CHOs conducted twice-weekly home visits (Tuesdays and Fridays) reviewing diary entries, providing individualized dietary counselling based on identified trends, assessing adherence and barriers, encouraging continued adherence, and flagging concerns for medical officers.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e\u003cp\u003e \u003cb\u003e4. Documentation and Monitoring Systems\u003c/b\u003e: Multi-tiered documentation systems were established to ensure comprehensive tracking:\u003c/p\u003e\u003col style=\"list-style-type:lower-roman;\"\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003ePatient Level\u003c/b\u003e: Food diaries with daily data and individual health cards documenting clinical parameters, treatment regimen, complications, immunizations, and specialist reports.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eSub-Centre Level\u003c/b\u003e: CHOs maintained NCD registers with dedicated pediatric T1D sections recording baseline information, home visit findings (post-prandial 2-hour blood sugar levels, counselling provided, issues identified, referrals made, follow-up plans, and visit logs documenting all interactions and advice provided.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eRBSK Level\u003c/b\u003e: Documentation of insulin training and competency assessment, weekly visit progress notes, growth parameters, referrals for complications, and training reinforcement activities.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eDistrict Level\u003c/b\u003e: A centralized, comprehensive registry was proposed with updated monthly captured clinical data, coverage metrics, resource utilization, training participation data, and implementation challenges using a simple Google spreadsheet. Monthly data validation meetings for documentation review and error correction with all stakeholders, and WhatsApp-based real-time reporting for critical issues ensured data quality and program responsiveness.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e\u003cp\u003e \u003cb\u003e5. Role Clarification Across Healthcare Cadres\u003c/b\u003e: Clear role \u0026amp; responsibility across all levels have been delineated, which reduced duplication and ensured accountability:\u003c/p\u003e\u003col style=\"list-style-type:lower-roman;\"\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eFamilies and Caregivers\u003c/b\u003e: Responsible for accurate food diary maintenance, insulin schedule adherence, daily glucose monitoring and recording, dietary recommendation compliance, training and follow-up attendance, adverse event reporting, safe insulin storage, safe sharps disposal, and peer support meeting participation.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eCommunity Health Officers\u003c/b\u003e: Provided dietary support through twice-weekly visits (Tuesdays and Fridays), reviewed food diaries, monitored post-prandial 2-hour blood sugar levels, delivered tailored dietary counseling, assessed adherence and identified barriers, maintained NCD registers, ensured timely follow-up with outreach for missed appointments, and participated in review meetings and refresher training.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eRBSK Medical Officers\u003c/b\u003e: Served as primary insulin training providers, conducted initial hands-on family training, weekly home visits for practice observation and feedback, ensured safe dosing and site rotation, documented training completion and competency achievement, identified and referred complications, and participated in coordination meetings.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003ePHC and CHC Medical Officers\u003c/b\u003e: Provided overall clinical oversight, reviewed progress during monthly meetings, adjusted insulin dose as needed, managed acute complications, mobilized resources through NPCDCS, Pradhan Mantri Jan Arogya Yojana (PMJAY), Rogi Kalyan Samiti (RKS), and available donor funds, facilitated specialist referrals and organized quarterly specialist camps, coordinated district-level activities, mentored field staff monthly, maintained the district registry, and generated monthly reports.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eDistrict Health Authorities\u003c/b\u003e: Provided policy support and administrative approvals, coordinated inter-departmental activities, ensured timely budget allocation, monitored program indicators, addressed systemic bottlenecks (staff vacancies, supply gaps), provided feedback and recognition to staff, and documented learning for dissemination and scale-up.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003cp\u003e \u003cb\u003e6. Financial Support Mechanisms\u003c/b\u003e: PHC and CHC medical officers coordinated access to glucometers and insulin through multiple funding streams, mainly from available government funds. PMJAY provided coverage for eligible families, NPCDCS drug budgets supplied essential medications, and RKS funds supported consumables. Eligibility prioritized below-poverty-line families, families in remote tribal areas, newly diagnosed children, and temporary supply gaps.\u003c/p\u003e\u003cp\u003e \u003cb\u003e7. Specialist Consultation and Peer Support\u003c/b\u003e: Quarterly endocrinology consultations were organized at the district hospital with transportation support for families from remote areas. Telemedicine consultations were arranged for routine follow-up, avoiding unnecessary travel while ensuring expert guidance. Peer support meetings facilitated experience sharing and mutual encouragement among families.\u003c/p\u003e\u003cp\u003e \u003cstrong\u003eEthics approval:\u003c/strong\u003e \u003c/p\u003e\u003cp\u003eThis initiative was part of a district health department-led public health program on Type 1 Diabetes care, with administrative approval from the Chief District Health Officer. It involved routine program monitoring and evaluation, using only aggregated, de-identified data without any experimental interventions. The activity posed minimal risk and, in line with national guidelines. Thus, neither Clinical trial registration nor individual consent was required.\u003c/p\u003e\n\u003ch3\u003eKey observations/Key findings\u003c/h3\u003e\n\u003cp\u003eAs the initiative is ongoing, observations/findings are presented as mid-line results in % calculated out of 124 enrolled children/adolescents over eight months of implementation (March-November 2024). The key findings of the initiative model pilot phase are described in Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e\u003c/p\u003e\u003col\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eA comprehensive district-wide Type 1 diabetes registry was established in Sabarkantha\u003c/b\u003e, enrolling 124 children/adolescents and enabling systematic documentation of clinical and care-related parameters. The registry expanded progressively from an initial cohort of 46 children identified in March–April 2024.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eAccess to essential diabetes care resources improved\u003c/b\u003e through coordinated mobilization of multiple funding mechanisms, resulting in enhanced availability of insulin and glucometers. Among enrolled children, 44% received donor-supported insulin \u0026amp; consultation check-up\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eHealthcare utilization shifted toward public facilities, with 48%\u003c/b\u003e transitioning to government health services for Type 1 diabetes management.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eHealth system perspective\u003c/b\u003e: Targeted capacity-building strengthened healthcare provider’s competency in paediatric T1D management, contributing to a 66% reduction in DKA-related hospitalizations.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003ePatient and caregiver perspective\u003c/b\u003e: 26.6% of children achieved reduced daily insulin doses, alongside improved peer support and emotional coping, which shows structured education improved self-care practices and disease understanding\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eGlycaemic Control\u003c/b\u003e: 54% showed improvement in their HbA1C in the last 8 months,\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eNutritional Status\u003c/b\u003e: Among children classified as underweight at baseline, 35% children gained sufficient weight to improve their nutritional status category\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003ch2\u003eImplementation Challenges\u003c/h2\u003e\u003cp\u003eCommunity-integrated T1D care model rollout was successful, though several implementation challenges were faced and required adaptive strategies:\u003c/p\u003e\u003cp\u003e \u003cstrong\u003eFinancial Sustainability Concerns\u003c/strong\u003e \u003c/p\u003e\u003cp\u003eTo identify \u0026amp; sustain the multiple funding streams to facilitate continuity of care and regular quarterly specialist visits proved challenging. Disruption in the flow of funds influenced the process of disbursement and procurement, sometimes disrupting continuity in the provision of items/medicines. Along with that, maintaining various funding streams increased administrative burdens as it required a volume of documentation associated with those funds.\u003c/p\u003e\u003cp\u003e \u003cstrong\u003eAwareness and Education Barriers\u003c/strong\u003e \u003c/p\u003e\u003cp\u003eEarly implementation phase reported resistance from families due to deep-rooted misconceptions about the disease and its treatment. Lack of capacity in the health infrastructure and integration of different stakeholders at different levels in the districts created logistical problems in promoting uniform education for newly enrolled children.\u003c/p\u003e\u003cp\u003e \u003cstrong\u003eTechnology and Infrastructure Constraints\u003c/strong\u003e \u003c/p\u003e\u003cp\u003eImplementing telemedicine in tribal areas remained challenging due to poor connectivity. Also, establishing a WhatsApp-based communication network required digital literacy support for some stakeholders.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e \u003cstrong\u003eFollow-Up and Reporting Mechanism issues\u003c/strong\u003e \u003c/p\u003e\u003cp\u003eInitially, it was difficult to maintain structured follow-up visits due to the multiple duties of all levels of cadre, as they were dealing with various activities and programs at the same time. Also, home-based care depended on continued motivation and availability of CHO and RBSK teams across geographically dispersed locations. Concurrently ensuring data quality across paper-based food diaries, facility registers, and the electronic district registry required continuous supervision and validation.\u003c/p\u003e\u003cp\u003e \u003cb\u003eGaps in Psychosocial Support\u003c/b\u003e: In addressing deeply rooted psychosocial concerns required to build trust with families, there may be a hesitation to share emotional struggles during initial interactions. Organized peer support group meetings proved to be a logistical burden, considering the geographical dispersal of families within the district. Inclusion of psychosocial support within clinical contacts took additional time considering heavy loads of health care providers.\u003c/p\u003e\u003cp\u003eThese issues were not completely addressed but were instead dealt with through adaptive approaches such as creating buffer stocks to fill gaps, making schedules for rotating visits to cover as many as possible with the same personnel, focusing on priority cases when conditions were limited, and finding acceptable solutions and constantly improving on these practices. The brief Implementation challenges, adopted strategies to overcome the challenges and evidence-based recommendations are illustrated in Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e"},{"header":"Discussion \u0026 Recommendations","content":"\u003cp\u003eThe Sabarkantha Model proves that a comprehensive and effective pediatric program for T1D can be successfully achieved within existing resources by integrating them into the primary care structure. Emphasis in the Sabarkantha Model has been on multi-level capacity building, financial support mechanisms, and the participatory approach of all stakeholders, including the affected children as well as their caregivers. participation of children and adolescents as equal partners. After just eight months of the implementation of the initiative, results were conclusive and included improved control of diabetes in 54% of children enrolled, a decrease in the rate of admissions due to diabetic ketoacidosis by 66%, and the use of public health care services rising to 48%.\u003c/p\u003e\u003cp\u003eIn contrast to other models in developed nations relying heavily on expert human resources, advanced technology, and high costs, the Sabarkantha Model demonstrates feasibility and impact through decentralized care, primary health platforms, and community health worker networks operating under constrained resources. The model leverages other innovations from states such as West Bengal and Karnataka, with additional components including structured insulin skills training by RBSK medical officers, regular food diary maintenance, CHO home visits, and multi-source public funding approaches. Unlike programs run or initiated by NGOs and donor agencies, there appears to be a certain viability to implementing these programs within a governmental framework.\u003c/p\u003e\u003cp\u003eHowever, certain limitations are worth consideration. The follow-up duration is only eight months, and thus, it is not possible to state the sustainability and outcomes on a long-term scale. There is no comparison or control district, which is an issue from the perspective of establishing the effectiveness of initiatives, because it is impossible to determine causal relations solely based on this initiative. Furthermore, despite careful enrollment techniques, selection bias may remain, especially when considering children from far-off tribal areas or those from private healthcare facilities only.\u003c/p\u003e\u003cp\u003eTo make this a successful, self-sustaining program and to implement it on a larger scale, there are some recommendations based on evidence.\u003c/p\u003e\u003cp\u003eFirstly, upgradation of service delivery is important. Involves the upgradation of pediatric endocrinology or training existing HCPs at various levels by means of training programs. Upgradation of telemedicine infrastructure, periodic expert consultations into systems, is a very important enabler of accessibility to specialists in geographically remote locations. consultation, telemedicine, and preparation of hub and spoke models of tertiary and district hospitals.\u003c/p\u003e\u003cp\u003eRegarding policy considerations, there is a need to formally incorporate OPD and IPD care packages of T1D within PMJAY to provide financial protection. The inclusion of T1D within the larger framework of NPCDCS and the formulation of national guidelines regarding screening, diagnosis, management, and follow-up of T1D would help to formally include T1D indicators in national information systems at a monitoring and accountability level.\u003c/p\u003e\u003cp\u003eThe priority areas in the development of programs are preparing transitional protocols for adolescents as they shift services into adult care systems and incorporating psychosocial services through screening and counselling. These are fundamental in dealing with psychosocial risks.\u003c/p\u003e\u003cp\u003e It is recommended that the research agenda include evaluation studies, cost-effectiveness studies, qualitative work related to families and caregivers, as well as studies related to implementing it in other regions, which would help in evaluating how well it adapts in different geographic regions.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe Sabarkantha model proves that the art of comprehensive management of T1D can be achieved within the existing framework of public health care systems available in low-resource and tribal areas through strategic optimisation of resources. Capacity building, financial protection, and involvement of the concerned community members will contribute as key observations at the clinical level as well as at the system level, thus providing disciplinary success to the concerned model of care. It offers a replicable blueprint for managing T1D conditions in rural and tribal settings.\u003c/p\u003e"},{"header":"Declarations","content":" \u003cp\u003e \u003cstrong\u003eEthical approval\u003c/strong\u003e \u003cp\u003eThis manuscript reports findings from a pilot implementation of initiatives conducted under a routine public health programme and initiated by the District Health Authorities of Sabarkantha, Gujarat. The analysis used de-identified programme data collected during standard care. No additional interventions were performed for research purposes. Thus, formal ethics committee approval was not applicable. The initiative followed the ethical principles of the Declaration of Helsinki and relevant national public health guidelines.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eConsent to participate\u003c/strong\u003e \u003cp\u003eParticipants were enrolled as part of routine care under the National Programme for Prevention and Control of Non-Communicable Diseases (NPCDCS), and no additional procedures were performed for research purposes. The analysis used de-identified programme data only. In line with the Declaration of Helsinki (2013) and ICMR National Ethical Guidelines (2017), separate informed consent for research participation was not required.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eConsent to publish\u003c/strong\u003e \u003cp\u003eNo individual-level identifiable data are presented in this manuscript. All data were analysed and reported in an aggregated and anonymised manner; therefore, consent for publication of individual participant data was not applicable.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eCONFLICTS OF INTEREST:\u003c/strong\u003e \u003cp\u003eThe authors declare no conflicts of interest related to this work.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFUNDING STATEMENT:\u003c/h2\u003e \u003cp\u003eNo financial support\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eCP and RS Conceptualise the proposed Model. NM assisted in the monitoring \u0026amp; evaluation of this model in the field. FM have drafted the first draft of the manuscript; KS \u0026amp; TP reviewed \u0026amp; edited the manuscript. All authors have read \u0026amp; approved the final draft of the manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eThe authors acknowledge the PHC MO, RBSK team, and CHOs for their dedication to implementing this model. We thank the District Health Administration for administrative help in this process. The authors are grateful to the diabetologists/pediatric endocrinologists who provided consultation/training inputs in this process. The authors thank all those who helped in this process financially by providing insulin/monitoring materials in this effort. And last but not least, we thank all children/adolescents \u0026amp; their caregivers who participated in this intervention model, cooperated in all process and shared their experiences to improve care for others.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe dataset used for this analysis is the property of the district health authority and was accessed with administrative approval from the District Health Officers. The data were provided in aggregated and de-identified form as part of routine public health program monitoring.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eType 1 Diabetes | International Diabetes Federation. https://idf.org/about-diabetes/types-of-diabetes/type-1-diabetes/. Accessed 28 Dec 2025\u003c/li\u003e\n\u003cli\u003eGregory GA, Robinson TIG, Linklater SE, et al (2022) Global incidence, prevalence, and mortality of type 1 diabetes in 2021 with projection to 2040: a modelling study. Lancet Diabetes Endocrinol 10:741\u0026ndash;760. https://doi.org/10.1016/S2213-8587(22)00218-2\u003c/li\u003e\n\u003cli\u003eHome | International Diabetes Federation. https://idf.org/. Accessed 28 Dec 2025\u003c/li\u003e\n\u003cli\u003eMadhu S V., Shukla P, Kaur T, Dhaliwal RS (2024) Mortality in type 1 diabetes mellitus: A single centre experience from the ICMR \u0026ndash; Youth onset diabetes registry in India. Diabetes Res Clin Pract 217:. https://doi.org/10.1016/j.diabres.2024.111868\u003c/li\u003e\n\u003cli\u003eGhosh S, Yasmin M, Sen K, et al (2023) Integrated Care for Type 1 Diabetes: The West Bengal Model. Indian J Endocrinol Metab 27:398\u0026ndash;403. https://doi.org/10.4103/IJEM.IJEM_124_23\u003c/li\u003e\n\u003cli\u003ePihoker C, Forsander G, Fantahun B, et al (2018) ISPAD Clinical Practice Consensus Guidelines 2018: The delivery of ambulatory diabetes care to children and adolescents with diabetes. Pediatr Diabetes 19 Suppl 27:84\u0026ndash;104. https://doi.org/10.1111/PEDI.12757\u003c/li\u003e\n\u003cli\u003eLong-Term Effect of Diabetes and Its Treatment on Cognitive Function. New England Journal of Medicine 356:1842\u0026ndash;1852. https://doi.org/10.1056/NEJMOA066397\u003c/li\u003e\n\u003cli\u003eNational Programme for prevention \u0026amp; Control of Cancer, Diabetes, Cardiovascular Diseases \u0026amp; stroke (NPCDCS) :: National Health Mission. https://nhm.gov.in/index1.php?lang=1\u0026amp;level=2\u0026amp;sublinkid=1048\u0026amp;lid=604. Accessed 28 Dec 2025\u003c/li\u003e\n\u003cli\u003eadmin Operational Guidelines for Implementation of National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) for year 2013-17 Operational Guidelines for Implementation of NPCDCS for year 2013-17\u003c/li\u003e\n\u003cli\u003eYasmin M, Mukhopadhyay P, Ghosh S (2022) Model of care for Type 1 diabetes in India: Integrated approach for its incorporation in future national health care policy. The Lancet Regional Health - Southeast Asia 3:. https://doi.org/10.1016/j.lansea.2022.05.003\u003c/li\u003e\n\u003cli\u003e(PDF) Evaluation of National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular disease and Stroke (NPCDCS) in Gandhinagar district, Gujarat 1 2 3. https://www.researchgate.net/publication/337705578_Evaluation_of_National_Programme_for_Prevention_and_Control_of_Cancer_Diabetes_Cardiovascular_disease_and_Stroke_NPCDCS_in_Gandhinagar_district_Gujarat_1_2_3. Accessed 28 Dec 2025\u003c/li\u003e\n\u003cli\u003eGhosh S, Yasmin M, Sen K, et al (2023) Integrated Care for Type 1 Diabetes: The West Bengal Model. Indian J Endocrinol Metab 27:398\u0026ndash;403. https://doi.org/10.4103/IJEM.IJEM_124_23\u003c/li\u003e\n\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":"discover-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [Discover Public Health](https://link.springer.com/journal/12982)","snPcode":"12982","submissionUrl":"https://submission.springernature.com/new-submission/12982/3","title":"Discover Public Health","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Discover Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Type 1 diabetes, Community-integrated care, Implementation research, Health system strengthening, Gujarat","lastPublishedDoi":"10.21203/rs.3.rs-8484082/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8484082/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eType 1 diabetes (T1D) affects over 280,000 children in India, with their average life expectancy being only 29 years compared to 65 years in high-income countries. This is due to gaps in insulin availability, structured education, and systematic follow-up in the national public health system. Though there is an existing NPCDCS for diabetes control, its reach is exclusively for adults. In response, a comprehensive, integrated model for community-based T1D care was developed and piloted within the existing primary health care system in the Sabarkantha district, Gujarat.\u003c/p\u003e\u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eThis model initiative aims to strengthen the management of children/adolescents aged 0\u0026ndash;19 years living with T1D.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThe proposed model was developed \u0026amp; piloted in Sabarkantha district, from January 2024 onwards, leveraging existing primary healthcare infrastructure. It consists of various components, including capacity building of healthcare providers \u0026amp; community, food diary-based dietary monitoring, multi-tiered documentation, role clarification across healthcare cadres, financial support mechanisms, and quarterly specialist consultations.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eWithin eight months, the initiative showed measurable improvements. 54% of the participants showed improvement in glycaemic control, 26.6% reduced insulin requirements, and 35% gained weight among those classified as underweight. Additionally, diabetic ketoacidosis-related hospitalisations were reduced by 66%. In terms of healthcare utilization, 48% shifted toward public facilities. Health system indicators documented establishment of a comprehensive district registry with 124 children/adolescents with T1D, standardization of care protocols, enhanced healthcare provider competency in pediatric insulin management, and improved family self-care practices. Financial support mechanisms provided expert consultations, \u0026amp; 44% of beneficiaries managed their insulin from various available funds.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThis proposed Model demonstrates that comprehensive pediatric T1D care is achievable within resource- constrained settings through strategic optimisation of existing resources integration \u0026amp; offers a replicable blueprint for managing T1D conditions in rural and tribal settings.\u003c/p\u003e","manuscriptTitle":"Early Implementation Insights from a Community-Integrated Care Model to Strengthen Type 1 Diabetes Management in Rural Gujarat","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-03-09 07:07:59","doi":"10.21203/rs.3.rs-8484082/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-04-09T10:23:49+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-04-08T04:46:05+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-03-15T23:02:29+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"152330305671395721312035042479171446887","date":"2026-03-13T16:14:16+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"254538582639298379608863846536068945663","date":"2026-03-05T15:49:37+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-03-03T15:40:02+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-01-21T07:02:10+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-01-20T11:31:11+00:00","index":"","fulltext":""},{"type":"submitted","content":"Discover Public Health","date":"2026-01-20T11:21:02+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
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