Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin‐treated type 1 and type 2 diabetes: the global HAT study
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AIMS: To determine the global extent of hypoglycaemia experienced by patients with diabetes using insulin, as there is a lack of data on the prevalence of hypoglycaemia in developed and developing countries. METHODS: This non-interventional, multicentre, 6-month retrospective and 4-week prospective study using self-assessment questionnaire and patient diaries included 27 585 patients, aged ≥18 years, with type 1 diabetes (T1D; n = 8022) or type 2 diabetes (T2D; n = 19 563) treated with insulin for >12 months, at 2004 sites in 24 countries worldwide. The primary endpoint was the proportion of patients experiencing at least one hypoglycaemic event during the observational period. RESULTS: During the prospective period, 83.0% of patients with T1D and 46.5% of patients with T2D reported hypoglycaemia. Rates of any, nocturnal and severe hypoglycaemia were 73.3 [95% confidence interval (CI) 72.6-74.0], 11.3 (95% CI 11.0-11.6) and 4.9 (95% CI 4.7-5.1) events/patient-year for T1D and 19.3 (95% CI 19.1-19.6), 3.7 (95% CI 3.6-3.8) and 2.5 events/patient-year (95% CI 2.4-2.5) for T2D, respectively. The highest rates of any hypoglycaemia were observed in Latin America for T1D and Russia for T2D. Glycated haemoglobin level was not a significant predictor of hypoglycaemia. CONCLUSIONS: We report hypoglycaemia rates in a global population, including those in countries without previous data. Overall hypoglycaemia rates were high, with large variations between geographical regions. Further investigation into these differences may help to optimize therapy and reduce the risk of hypoglycaemia.
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Occurrences of severe hypoglycemia and DKA (9.0 and 0.6 events per 100 person-years, respectively, in the safety cohort) observed during the study period are in line with other literature with estimates ranging from 7 to 130 and 4 to 8 events per 100 person-years, respectively, in insulin-requiring diabetes populations using MDI therapy.
“Occurrences of severe hypoglycemia and DKA (9.0 and 0.6 events per 100 person-years, respectively, in the safety cohort) observed during the study period are in line with other literature with estimates ranging from 7 to 130 and 4 to 8 events per 100 person-years, respectively, in insulin-requiring diabetes populations using MDI therapy (39-43).”
From Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis (2025) · cites this paper as [42]
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- Authors
- Khunti, K., Alsifri, S., Aronson, R., Cigrovski Berković, M., Enters‐Weijnen, C., Forsén, T., Galstyan, G., Geelhoed‐Duijvestijn, P., Goldfracht, M., Gydesen, H., Kapur, R., Lalic, N., Ludvik, B., Moberg, E., Pedersen‐Bjergaard, U., Ramachandran, A., & on behalf of the HAT Investigator Group
- Affiliations
- University of Leicester (GB)
- Armed Forces Hospital (SA)
- LMC Diabetes & Endocrinology (Canada) (CA)
- University Hospital ‘Sestre Milosrdnice’ Zagreb Croatia
- Julius Clinical/Julius Center UMC Utrecht Zeist the Netherlands
- University of Helsinki (FI)
- Endocrinology Research Center (RU)
- Medical Center Haaglanden The Hague the Netherlands
- Technion – Israel Institute of Technology (IL)
- Novo Nordisk (Denmark) (DK)
- University of Belgrade (RS)
- Krankenanstalt Rudolfstiftung der Stadt Wien (AT)
- Karolinska Institutet (SE)
- Nordsjællands Hospital (DK)
- India Diabetes Research Foundation (IN)
- Corresponding author
- Khunti, K.
- ORCID
- Venue
- Diabetes Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2016-06-20
- Volume
- 18
- Issue
- 9
- Pages
- 907-915
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- PMC
- PMC5031206
- OpenAlex
- W2388825372
- Cited by
- 276
- References
- 27
- Citations by year
- 2026: 22 · 2025: 21 · 2024: 32 · 2023: 23 · 2022: 25 · 2021: 26 · 2020: 30 · 2019: 28 · 2018: 42 · 2017: 23 · 2016: 3
- FWCI
- 32.17
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes Obesity and Metabolism (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, cc-by)
- Figshare (submittedVersion, cc-by)
- Työväentutkimus Vuosikirja (submittedVersion, other-oa)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by)
- Funders
- National Institute for Health Research
- Novo Nordisk
- Bristol-Myers Squibb
- AstraZeneca
- Sanofi
- Boehringer Ingelheim
- Medtronic
- Takeda Pharmaceuticals U.S.A.
- Medpace
- GlaxoSmithKline
- Pfizer
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- hypoglycemia, insulin-treated diabetes, type 1 diabetes, type 2 diabetes, nocturnal hypoglycemia, severe hypoglycemia, HbA1c
- MeSH terms
- Adult, Aged, Asia, Southeastern, Canada, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Europe, Europe, Eastern, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Latin America, Male, Middle Aged, Middle East, Prospective Studies, Surveys and Questionnaires, Retrospective Studies, Risk Factors, Russia, Severity of Illness Index, Prevalence
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