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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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posted on 2016-11-16, 10:15 authored by K. Khunti, S. Alsifri, R. Aronson, M. Cigrovski Berković, C. Enters-Weijnen, T. Forsén, G. Galstyan, P. Geelhoed-Duijvestijn, M. Goldfracht, H. Gydesen, R. Kapur, N. Lalic, B. Ludvik, E. Moberg, U. Pedersen-Bjergaard, A. Ramachandran, HAT Investigator Group
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.


Statistical analysis was performed by Parexel. The authors acknowledge medical writing support provided by Dr Paul Tisdale and Gabrielle Parker of Watermeadow Medical and Dr Nason Maani Hessari and Dr Lucy Smithers of apothecom scopemedical, funded by Novo Nordisk. K.K. is supported by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care – East Midlands (NIHR CIAHRC – EM), the Leicester Clinical Trials Unit and the NIHR Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit, which is a partnership between University Hospitals of Leicester NHS Trust, Loughborough University and the University of Leicester, UK.



Diabetes, Obesity and Metabolism, 2016, 18 (9), pp. 907-915

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/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Health Sciences


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Additional Supporting Information may be found in the online version of this article: File S1. Patient disposition by country. File S2. Baseline characteristics by region of patients with type 1 diabetes. Table S1. Patient disposition by country. Table S2. Baseline characteristics by region of patients with type 1 diabetes. Table S3. Baseline characteristics by region of patients with type 2 diabetes. Table S4. Severe hypoglycaemia rates during the prospective period by geographic region.



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