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

Ulrik Pedersen-Bjergaard, Saud Alsifri, Ronnie Aronson, Maja Cigrovski Berković, Gagik Galstyan, Helge Gydesen, Jesper Barner Lekdorf, Bernhard Ludvik, Erik Moberg, Ambady Ramachandran, Kamlesh Khunti, Ulrik Pedersen-Bjergaard, Saud Alsifri, Ronnie Aronson, Maja Cigrovski Berković, Gagik Galstyan, Helge Gydesen, Jesper Barner Lekdorf, Bernhard Ludvik, Erik Moberg, Ambady Ramachandran, Kamlesh Khunti

Abstract

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 individuals 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 more than 24 000 participants with T1D and more than 160 000 participants with T2D, varied in design, size, inclusion criteria, definitions of hypoglycaemia and method of 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 and T2D, 1.3-37.7; mild/non-severe T1D, 29.0-126.7 and T2D, 1.3-41.5; severe T1D, 0.7-5.8 and T2D, 0.0-2.5; nocturnal T1D, 2.6-11.3 and 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 among 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.

Keywords: hypoglycaemia; insulin therapy; observational study; systematic review; type 1 diabetes; type 2 diabetes.

Conflict of interest statement

U. P. B. has served on advisory boards for, and has received lecture fees, from AstraZeneca, Bristol‐Myers Squibb, Novo Nordisk and Sanofi‐Aventis. S. A. has no conflicts of interest to disclose. R. A. has provided research support to, has acted as a consultant to and advisory board member for, and has received research grants from Novo Nordisk, Janssen, Sanofi, Medtronic, Bristol‐Myers Squibb, AstraZeneca, Takeda, Becton Dickinson, Merck Sharp & Dohme, Boehringer Ingelheim, Regeneron, Eli Lilly, Abbot, Quintiles, ICON, Medpace and GlaxoSmithKline. M. C. B. has acted as a board member for Novo Nordisk and Novartis, and a speaker for Novo Nordisk, Eli Lilly, Merck Sharp & Dohme, AstraZeneca, Sanofi, Boehringer Ingelheim and Novartis. G. G. has served on advisory panels for and as a board member and speaker for Novo Nordisk, Eli Lilly, Merck Sharp & Dohme, AstraZeneca, Sanofi, Novartis and Takeda. H. G. and J. B. L are employees of Novo Nordisk.

B. L. has been a consultant to, and a speaker and advisory board member for AstraZeneca, Boehringer‐Ingelheim, Eli Lilly, MSD, Merck, Novartis, Novo Nordisk, Sanofi, Takeda, Roche and Servier. E. M. has served as a speaker for Novo Nordisk, Eli Lilly, Merck Sharp & Dohme, Sanofi and Boehringer Ingelheim. A. R. has served as an advisory board member and speaker for AstraZeneca, Bristol‐Myers Squibb, Novo Nordisk and Sanofi, and has received research grants from Novo Nordisk.

K. K. has been a consultant to, and a speaker and advisory board member for AstraZeneca, Novartis, Novo Nordisk, Sanofi‐Aventis, Lilly, Merck Sharp and Dohme, Janssen and Boehringer Ingelheim, and he has received grants in support of investigator‐initiated trials from AstraZeneca, Novartis, Novo Nordisk, Sanofi‐Aventis, Lilly, Boehringer Ingelheim, Merck Sharp and Dohme and Roche.

© 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Flow chart of selection of studies for inclusion

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