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Pedersen-Bjergaard_et_al-2018-Diabetes,_Obesity_and_Metabolism.pdf (794.84 kB)

Comparison of the HAT study, the largest global hypoglycaemia study to date, with similar large real-world studies.

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journal contribution
posted on 2019-05-31, 14:57 authored by U Pedersen-Bjergaard, S Alsifri, R Aronson, MC Berković, G Galstyan, H Gydesen, JB Lekdorf, B Ludvik, E Moberg, A Ramachandran, K Khunti
AIMS: Optimal diabetes care requires clear understanding of the incidence of hypoglycaemia in real-world clinical practice. Current data on hypoglycaemia are generally limited to those reported from randomised controlled clinical trials. The Hypoglycaemia Assessment Tool (HAT) study, a non-interventional real-world study of hypoglycaemia, assessed hypoglycaemia in 27,585 people across 24 countries. The present study compared the incidence of hypoglycaemia from the HAT study with other similarly designed, large, real-world studies. MATERIALS AND METHODS: A literature search of PubMed (1995-2017) for population-based studies of insulin-treated patients with type 1 or type 2 diabetes (T1D, T2D), excluding clinical trials and reviews, identified comparable population-based studies reporting the incidence of hypoglycaemia. RESULTS: The 24 comparative studies, including >24,000 participants with T1D and >160,000 participants with T2D, varied in design, size, inclusion criteria, definitions of hypoglycaemia and method for recording hypoglycaemia. Reported rates (events/per patient-year [PPY]) of hypoglycaemia were higher in patients with T1D than in those with T2D (overall T1D 21.8-73.3, T2D 1.3-37.7; mild/non-severe T1D 29.0-126.7, T2D 1.3-41.5; severe T1D 0.7-5.8, T2D 0.0-2.5; nocturnal T1D 2.6-11.3, T2D 0.38-9.7), and were similar to the ranges found in the HAT study. CONCLUSIONS: The HAT data on hypoglycaemia incidence were comparable with those from other real-world studies and indicate a high incidence of hypoglycaemia among insulin-treated patients. Differences in rates between studies are mostly explained by differences in patient populations and study methodology. The goal of reducing hypoglycaemia should be a target for continued educational and evidence-based pharmacological interventions.


The authors thank Watermeadow Medical, funded by Novo Nordisk, for medical writing and editorial assistance. K. K. acknowledges the support of the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care ‐ East Midlands (NIHR CLAHRC ‐ EM), and the NIHR Leicester Biomedical Research Centre. This review and the HAT study were sponsored by Novo Nordisk.



Diabetes, Obesity and Metabolism, 2018, 21(4), pp. 844-853

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