Fear of High Blood Sugar in Pregnancy Questionnaire: development of a person-reported outcome measure to assess fear of hyperglycaemia in pregnant women with type 1 diabetes

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Skip to main content Home About Submit ALERTS / RSS Search for this keyword Advanced Search Fear of High Blood Sugar in Pregnancy Questionnaire: development of a person-reported outcome measure to assess fear of hyperglycaemia in pregnant women with type 1 diabetes Jenny Gu , Amy Dunlop , Lois E Donovan , Kathleen H Chaput doi: https://doi.org/10.1101/2025.11.17.25340428 Jenny Gu 1 Department of Medicine, Cumming School of Medicine, University of Calgary , Calgary, Alberta, Canada , T2N 2T9 Find this author on Google Scholar Find this author on PubMed Search for this author on this site Amy Dunlop 1 Department of Medicine, Cumming School of Medicine, University of Calgary , Calgary, Alberta, Canada , T2N 2T9 Find this author on Google Scholar Find this author on PubMed Search for this author on this site Lois E Donovan 1 Department of Medicine, Cumming School of Medicine, University of Calgary , Calgary, Alberta, Canada , T2N 2T9 2 Department of Obstetrics and Gynaecology and Alberta Children’s Hospital Research Institute, University of Calgary , Calgary, Alberta, Canada , T2N 1N4 Find this author on Google Scholar Find this author on PubMed Search for this author on this site For correspondence: lois.donovan{at}ahs.ca Kathleen H Chaput 1 Department of Medicine, Cumming School of Medicine, University of Calgary , Calgary, Alberta, Canada , T2N 2T9 2 Department of Obstetrics and Gynaecology and Alberta Children’s Hospital Research Institute, University of Calgary , Calgary, Alberta, Canada , T2N 1N4 3 Department of Community Health Sciences, Cumming School of Medicine, University of Calgary , Calgary, Alberta, Canada , T2N 1N4 Find this author on Google Scholar Find this author on PubMed Search for this author on this site Abstract Full Text Info/History Metrics Data/Code Preview PDF Abstract Background Although newer diabetes technologies improve glycaemic outcomes in type 1 diabetes pregnancies, most studies have not demonstrated improvements in scores on person-reported outcome measures (PROMs). This is likely because commonly used PROMs do not effectively capture quality-of-life concerns of greatest importance to pregnant women with type 1 diabetes. Aims We aimed to develop a research questionnaire to evaluate fear of hyperglycaemia in type 1 diabetes pregnancies, which is an important person-reported outcome in this population. Methods The format of the questionnaire was modelled after that of the Hypoglycaemia Fear Survey-II. Items pertaining to fear of hyperglycaemia, specifically in pregnancy, were developed. The questionnaire was refined using cognitive interviewing among Canadian women with experience of type 1 diabetes in pregnancy. We recruited participants sequentially and modified our questionnaire iteratively based on participants’ feedback. Saturation was reached when no significant changes were made by three consecutive participants. Results The questionnaire was reviewed by nine participants with median type 1 diabetes duration of 22 years. The questionnaire asks about 16 behaviours to avoid hyperglycaemia in pregnancy and 12 worries related to hyperglycaemia in pregnancy. 5-point Likert scales are used to quantify frequency of behaviours and worries. Conclusions Type 1 diabetes management is challenging in pregnancy. One source of stress for women is the fear of hyperglycaemia and its effects on their unborn children. The Fear of High Blood Sugar in Pregnancy Questionnaire is a pregnancy-specific person-reported outcome measure which can begin to quantify the impact of diabetes management strategies on hyperglycaemia fear. Introduction During pregnancy, women with type 1 diabetes are advised to target blood glucose as close to the non-diabetes reference range as safely possible, in order to reduce the risk of maternal and neonatal complications. 1 , 2 Despite this, consistently achieving target glucose levels for women with type 1 diabetes in pregnancy is rarely attained and attempts to do so can pose tremendous stress and increase diabetes management burden. Currently available insulin delivery methods and durations of exogenous insulins still fall short of mimicking the function of a healthy pancreas. As a result, pregnant women with type 1 diabetes remain at risk of severe hypoglycaemia and struggle to keep up with the changes in insulin requirements throughout pregnancy that are needed to reduce hyperglycaemia. 3 Qualitative work by our group and others have highlighted the stress experienced by pregnant women with type 1 diabetes, related to fear of hyperglycaemia and possible consequences to their babies. 4 - 6 Studies of diabetes technologies have shown improved time in target glucose range and reduced time above target glucose range in pregnancy with the use of continuous glucose monitoring 2 and closed-loop insulin delivery. 7 , 8 Qualitative interviews of women with type 1 diabetes in pregnancy in the Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes (AiDAPT) study have highlighted that closed-loop insulin delivery can facilitate positive experiences of diabetes management in pregnancy. 5 However, the AiDAPT study failed to demonstrate improvements on standardised diabetes person-reported outcome measures (PROMs). 7 The CONCEPTT study similarly found that improved glycaemia with continuous glucose monitor use in pregnancy was accompanied by no improvements on standardised diabetes PROMs. 2 We have shown that a group of women with type 1 diabetes felt that existing standardised questionnaires do not adequately capture the quality-of-life outcomes that are of greatest importance during pregnancy, 4 which may explain the lack of observed benefits on PROMs and the discrepancy between the current qualitative and quantitative evidence surrounding type 1 diabetes in pregnancy. Given the lack of a standardised PROM to address the expressed concern of hyperglycaemia in pregnancy among women with type 1 diabetes, 4 we sought to develop a questionnaire to assess the fear of hyperglycaemia in pregnancy. Methods 1. Questionnaire development The proposed Fear of High Blood Sugar in Pregnancy Questionnaire was designed to be self-administered by women with type 1 diabetes at any one time, or at multiple times, during pregnancy, for research purposes. The first iteration of the questionnaire was developed by a member of the research team with lived experience of type 1 diabetes in pregnancy and was modelled after the Hypoglycaemia Fear Survey-II (HFS-II), which is a well-validated tool to assess fear of hypoglycaemia in type 1 diabetes. 9 , 10 The HFS-II asks about behaviours respondents engage in to avoid hypoglycaemia and worries related to lows. We developed a questionnaire with behaviour and worry subscales pertaining to hyperglycaemia and its consequences to both respondents and their babies. Item response options were 5-point Likert scales (“never”, “rarely”, “sometimes”, “often”, and “almost always”). To assess internal consistency of behaviour and worry subscales, we included questions about frequency of glucose monitoring, degree of hyperglycaemia-associated distress, and recent diabetic ketoacidosis. 2. Questionnaire revision through cognitive interviewing: study design We conducted cognitive interviews with women with lived experience of type 1 diabetes and pregnancy to ensure that our questionnaire captured the range of behaviours and worries that women have related to fear of hyperglycaemia in pregnancy. Structured one-on-one interviews were conducted with participants and our questionnaire was modified iteratively based on each participant’s feedback as they reviewed the questionnaire. The Conjoint Health Research Ethics Board at the University of Calgary approved this study (REB 21-0447). 3. Study participants We recruited Canadian participants through the University of Calgary’s Participate-in-Research website, and word-of-mouth messaging within the research team’s clinical networks. Individuals were eligible to participate in cognitive interviews if they were: 1) diagnosed with type 1 diabetes at least 12 months prior to a previous or current pregnancy; 2) able to speak and read English; 3) able to provide informed consent; and 4) able to meet with a member of the research team in person or had internet or phone access to meet virtually. 4. Study procedure Participants completed a questionnaire that collected demographic, diabetes history, and pregnancy history data. The first three digits of participants’ postal codes were collected to determine neighbourhood median income. 11 One-on-one interviews were conducted with each participant by one of two members of the research team. Participants were asked structured questions regarding each item in the behaviour and worry subscales of the questionnaire; specifically, whether each item was relevant, clear, focused, and non-judgmental. Participants were asked to propose alternative phrasings of items that were unsatisfactory, and to add new items that reflected experiences that were not already captured. The questionnaire was modified according to each participant’s responses, and the most updated version was used during each successive interview. If a participant proposed an edit that conflicted with that of a previous participant, both versions were presented to subsequent participants until a majority consensus was reached. We determined that saturation was reached when no significant changes were made to the questionnaire by three consecutive participants. Results 1. Participant characteristics Our study included nine participants who ranged in age from 29 to 39 years. Participants were primarily white (88.9%) and had neighbourhood median annual household incomes over $80,000 Canadian dollars (77.8%) ( Table 1 ). The median duration of diabetes was 22 years. Six out of nine participants were using an automated insulin delivery system at the time of study participation. Altogether the nine participants had experienced 25 pregnancies, three of which were ongoing at the time of study participation. Participants had children ranging in age from two months to 12 years. View this table: View inline View popup Download powerpoint Table 1: Participant characteristics. 2. Questionnaire Based on responses from the nine study participants, the proposed Fear of High Blood Sugar in Pregnancy Questionnaire was modified until the final version was developed ( Table 2 ). In the behaviour subscale, participants suggested items be rephrased in order to clearly distinguish between personal/recreational and work-related contexts, since they felt that their behaviours to manage hyperglycaemia were dependent on the setting. Multiple items were added to the worry subscale based on participant feedback, including worries about perceived judgment from health care providers, inadequate diabetes support from health care providers, and hyperglycaemia affecting labour and delivery plans. The item, “Because my blood sugar could go high, I worry about my baby’s health” was moved to the beginning of the worry subscale due to one participant’s feedback that her baby’s health was the most important concern during pregnancy, above any concerns to her own health. One participant felt that it was judgmental to ask if respondents gave more insulin than the pump-recommended bolus to avoid hyperglycaemia, however acknowledged that there was not another way to phrase the item. The remainder of the items in the questionnaire were perceived as non-judgmental. View this table: View inline View popup Table 2: Fear of High Blood Sugar in Pregnancy Questionnaire. Discussion Diabetes management during pregnancy is demanding. Given the substantial role that self-management plays in diabetes care, assessment of evolving diabetes management strategies should evaluate person-reported outcomes of concern to those living with diabetes and responsible for day-to-day management, in addition to glycaemic and other medical outcomes. Studies of automated insulin delivery in pregnancy have demonstrated benefits in terms of decreased worry about glucose control and decreased burden of diabetes management in qualitative interviews. 5 , 12 Qualitative interviewing, however, is costly, time-consuming, and can contribute to the burden of research participation during pregnancy, a period when diabetes management is already overwhelming. 13 , 14 In addition, qualitative studies do not allow for the generation of quantitative evidence and are challenging to standardise across research practice, which limit the comparability of findings across different studies. Person-reported outcome measures that are simple to administer and do not add substantially to the demands of research participation would be a preferred method of assessing the impact of evolving diabetes management strategies on quality-of-life outcomes. Most type 1 diabetes pregnancy trials to date have not shown benefits in the scores of commonly used PROMs, 2 , 7 , 12 , 15 , 16 likely because the PROMs used do not effectively capture the outcomes of greatest importance to pregnant women with type 1 diabetes. 4 Fear of hyperglycaemia is an important person-reported outcome among pregnant women with type 1 diabetes. 4 Our questionnaire, developed using input from women with experience of type 1 diabetes and pregnancy, systematically quantifies fear of hyperglycaemia in pregnancy. To our knowledge, this is the first questionnaire to evaluate fear of hyperglycaemia in pregnant women with type 1 diabetes. Polonsky et al. found that in a sample of adults with type 1 diabetes, asking three items related to hyperglycaemia aversiveness identified a subset of the sample with significantly greater time in range, lower glucose management indicator, and more severe hypoglycaemia. 17 The motivation of those with hyperglycaemia aversiveness was thought to be avoidance of long-term complications of diabetes. 17 Singh et al. developed the Hyperglycaemia Avoidance Scale, a 22-item questionnaire that quantifies preference for low blood glucose and worries and behaviours related to hyperglycaemia. 18 These previous works are not specific to pregnancy, a time during which women with type 1 diabetes have increased fear of high blood sugar due to its potential consequences to their babies, rather than to themselves. 5 , 6 , 13 A recent consensus statement emphasized the need to assess PROMs both in research and in clinical practice, since psychosocial functioning and mental health status profoundly influence self-management behaviours and overall health outcomes in diabetes. 19 Listening to the perspectives of people with diabetes is important in determining which person-reported outcomes to assess, since their concerns and priorities may differ from the traditional clinical and research outcomes of glycaemic and medical complications. The Fear of High Blood Sugar in Pregnancy Questionnaire was created in response to our previous qualitative work, where we found that fear of hyperglycaemia is a prevalent concern amongst women with type 1 diabetes in pregnancy, and there is need for a PROM that evaluates this. 4 A strength of our questionnaire is that it was developed by a member of the research team with lived experience of type 1 diabetes in pregnancy, and further revisions were made in collaboration with women with type 1 diabetes and pregnancy experience. Study participants had experience with various methods of insulin delivery during pregnancy; some had experienced multiple methods of insulin delivery across different pregnancies, including automated insulin delivery. A limitation of our questionnaire is the lack of available data to assess its internal consistency, external consistency, reliability, and validity. We did not have access to participants’ clinical data to determine if scores on our questionnaire correlated to measures such as time in range, time below range, or incidence of severe hypoglycaemia. However, the person-oriented methods used in developing our questionnaire ensure that it has strong face and content validity as a PROM. Given the need for such a questionnaire in current diabetes in pregnancy research, we hope that this questionnaire will prove useful to researchers and that its broadened use will allow for future work to determine reliability and validity. Another limitation was that our study participants were of high socioeconomic status and the majority were white or Caucasian, which does not reflect the diversity of women with type 1 diabetes. Future work with this tool in a more diverse group of women with type 1 diabetes is needed. Future studies should confirm the validity and reliability of this questionnaire in both research and clinical settings. Conclusions Type 1 diabetes management is particularly challenging in pregnancy, and one source of stress for pregnant women is the fear of hyperglycaemia and its effects on their unborn children. This project created the Fear of High Blood Sugar in Pregnancy Questionnaire, which is the first step in the development of a pregnancy-specific PROM to be used to assess the quality-of-life impact of evolving diabetes management strategies for pregnancy. Data Availability All data produced in the present work are contained in the manuscript Author Contributions AD developed the first draft of the person-reported outcome measure. JG and AD interviewed participants. AD, KHC, and LED designed the study, and reviewed, edited, and approved the manuscript. Acknowledgements The authors thank the participants of this study for sharing their experiences of type 1 diabetes in pregnancy. The authors thank L Gonder-Frederick and D Cox, creators of the Hypoglycaemia Fear Survey-II, whose work is the foundation for the questionnaire presented here. We thank J Booth for assistance with manuscript preparation. Footnotes Donovan and Chaput should be considered joint senior author. Funding: None Conflicts of Interest: LED reports in-kind donations and reduced cost for study supplies for investigator-initiated trials from Medtronic, Dexcom, Tandem Diabetes Care, and Inter-analytics. Bulleted Novelty Statement: -Diabetes management strategies that address medical and psychological concerns of those with type 1 diabetes during pregnancy are needed. -Qualitative work has shown that technology improves diabetes management experiences in pregnancy. However, most studies show no quantitative benefits on person-reported outcome measures, likely because existing measures do not capture outcomes of importance to these individuals. -We present a questionnaire to assess hyperglycaemia fear in pregnancy, an outcome that those living with type 1 diabetes have identified as important. -Future research can begin to quantify the impact of new diabetes management strategies on hyperglycaemia fear in pregnancy. References 1. ↵ Battelino T , Danne T , Bergenstal RM , Amiel SA , Beck R , Biester T , Bosi E , Buckingham BA , Cefalu WT , Close KL , Cobelli C , Dassau E , DeVries JH , Donaghue KC , Dovc K , Doyle FJ , Garg S , Grunberger G , Heller S , Heinemann L , Hirsch IB , Hovorka R , Jia W , Kordonouri O , Kovatchev B , Kowalski A , Laffel L , Levine B , Mayorov A , Mathieu C , Murphy HR , Nimri R , Nørgaard K , Parkin CG , Renard E , Rodbard D , Saboo B , Schatz D , Stoner K , Urakami T , Weinzimer SA , Phillip M. 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OpenUrl 19. ↵ Barnard-Kelly K , Marrero D , de Wit M , Pouwer F , Khunti K , Hermans N , Pierce JS , Laffel L , Holt RIG , Battelino T , Naranjo D , Fosbury J , Fisher L , Polonsky W , Weissberg-Benchell J , Hood KK , Schnell O , Messer LH , Danne T , Nimri R , Skovlund SE , Mader JK , Sherr JL , Schatz D , O’Neill S , Doble E , Town M , Lange K , de Beaufort C , Gonder-Frederick L , Jaser SS , Liberman A , Klonoff D , ElSayed NA , Bannuru RR , Parkin CG , Snoek F. Towards the standardisation of adult person-reported outcome domains in diabetes research: a Consensus Statement development panel . Diabet Med . 2024 : e15332 . View the discussion thread. Back to top Previous Next Posted November 19, 2025. Download PDF Data/Code Email Thank you for your interest in spreading the word about medRxiv. NOTE: Your email address is requested solely to identify you as the sender of this article. 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Share Fear of High Blood Sugar in Pregnancy Questionnaire: development of a person-reported outcome measure to assess fear of hyperglycaemia in pregnant women with type 1 diabetes Jenny Gu , Amy Dunlop , Lois E Donovan , Kathleen H Chaput medRxiv 2025.11.17.25340428; doi: https://doi.org/10.1101/2025.11.17.25340428 Share This Article: Copy Citation Tools Fear of High Blood Sugar in Pregnancy Questionnaire: development of a person-reported outcome measure to assess fear of hyperglycaemia in pregnant women with type 1 diabetes Jenny Gu , Amy Dunlop , Lois E Donovan , Kathleen H Chaput medRxiv 2025.11.17.25340428; doi: https://doi.org/10.1101/2025.11.17.25340428 Citation Manager Formats BibTeX Bookends EasyBib EndNote (tagged) EndNote 8 (xml) Medlars Mendeley Papers RefWorks Tagged Ref Manager RIS Zotero Tweet Widget Facebook Like Google Plus One Subject Area Endocrinology (including Diabetes Mellitus and Metabolic Disease) Subject Areas All Articles Addiction Medicine (568) Allergy and Immunology (863) Anesthesia (300) Cardiovascular Medicine (4435) Dentistry and Oral Medicine (444) Dermatology (382) Emergency Medicine (608) Endocrinology (including Diabetes Mellitus and Metabolic Disease) (1509) Epidemiology (15229) Forensic Medicine (30) Gastroenterology (1124) Genetic and Genomic Medicine (6600) Geriatric Medicine (668) Health Economics (997) Health Informatics (4536) Health Policy (1368) Health Systems and Quality Improvement (1613) Hematology (541) HIV/AIDS (1264) Infectious Diseases (except HIV/AIDS) (15916) Intensive Care and Critical Care Medicine (1103) Medical Education (623) Medical Ethics (146) Nephrology (667) Neurology (6599) Nursing (346) Nutrition (998) Obstetrics and Gynecology (1144) Occupational and Environmental Health (957) Oncology (3332) Ophthalmology (974) Orthopedics (369) Otolaryngology (420) Pain Medicine (436) Palliative Medicine (130) Pathology (663) Pediatrics (1693) Pharmacology and Therapeutics (691) Primary Care Research (711) Psychiatry and Clinical Psychology (5447) Public and Global Health (9232) Radiology and Imaging (2198) Rehabilitation Medicine and Physical Therapy (1370) Respiratory Medicine (1196) Rheumatology (593) Sexual and Reproductive Health (712) Sports Medicine (530) Surgery (712) Toxicology (99) Transplantation (289) Urology (265) (function(){function c(){var b=a.contentDocument||a.contentWindow.document;if(b){var d=b.createElement('script');d.innerHTML="window.__CF$cv$params={r:'a00b37155a6e9c08',t:'MTc3OTYxNDMyOQ=='};var a=document.createElement('script');a.src='/cdn-cgi/challenge-platform/scripts/jsd/main.js';document.getElementsByTagName('head')[0].appendChild(a);";b.getElementsByTagName('head')[0].appendChild(d)}}if(document.body){var a=document.createElement('iframe');a.height=1;a.width=1;a.style.position='absolute';a.style.top=0;a.style.left=0;a.style.border='none';a.style.visibility='hidden';document.body.appendChild(a);if('loading'!==document.readyState)c();else if(window.addEventListener)document.addEventListener('DOMContentLoaded',c);else{var e=document.onreadystatechange||function(){};document.onreadystatechange=function(b){e(b);'loading'!==document.readyState&&(document.onreadystatechange=e,c())}}}})();