Risk of severe hypoglycaemia for various treatment regimens – a systematic review and meta-analysis of observational studies

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Background: Previous publications show that diabetes mellitus (DM) is a grave medical and economic problem, largely due to complications. The objective is to evaluate real-life risk of severe hypoglycaemic events (SHEs) among diabetic patients (type 1 and 2, T1&2) for various therapies. Methods: We conducted a systematic review of observational studies in MEDLINE, Embase, and The Cochrane Library databases. Observational, retrospective or prospective, studies (with at least 100 participants) in children and adults were included, with focus on: time horizon, number of patients, number of SHEs, and number of patients experiencing SHEs. In T1 DM we distinguished basal-bolus/pre-mix insulin and insulin pump, and in T2 DM we singled out basal-bolus/pre-mix insulin, basal supported oral therapy with insulin as the basal component, sulfonylurea, and other antidiabetic medications. We used a Poisson model implemented in Bayesian framework in WinBugs to estimate the SHE. Results: We identified 55 relevant studies encompassing 245,028 patients (103,741.81 patient-years). Annual SHE rates varied in T1DM from 0.18 (95%CI: 0.13–0.25) for insulin pump up to 1.1 (0.57–2.71) for basal-bolus with human basal insulin, and in T2DM from 0.006 (0.001–0.008) for oral antidiabetic drugs (excl. SU) up to 0.56 (0.16–9.65) for basal-bolus with human insulin as the basal component. Conclusions: Our results confirm that available treatment regimens differ in SHEs risk in real-life setting. Still SHEs are also driven by other factors, e.g. lifestyle, which may impact treatment selection.