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

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