Abstract
AimsTo 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.MethodsThis 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.ResultsDuring 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.ConclusionsWe 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.
Highlights
Insulin therapy is essential for the treatment of type 1 diabetes (T1D), and is often required for people with type 2 diabetes (T2D)
The present study examined hypoglycaemia prevalence and rates in a large global cohort of insulin-treated patients with diabetes, including many countries and several regions with no previously published data
Patient-reported hypoglycaemia in a global population occurred at a higher frequency than previously reported, with marked variations across geographic regions
Summary
Insulin therapy is essential for the treatment of type 1 diabetes (T1D), and is often required for people with type 2 diabetes (T2D). DIABETES, OBESITY AND METABOLISM such studies are conducted under controlled conditions, with regular contact and follow-up between patients and trial physicians, and are often of a treat-to-target design to meet regulatory requirements [8]. Both this selection of patients and trial design are likely to influence the observed rate of hypoglycaemia
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