Incidence and severity of hypoglycaemia in type 2 diabetes by treatment regimen: A UK multisite 12‐month prospective observational study

Aims To determine the incidence and severity of self‐reported hypoglycaemia in a primary care population with type 2 diabetes. The study also aimed to compare incidence by treatment regimen. Materials and methods A prospective observational study in 17 centres throughout the UK was conducted. Recruitment was based on treatment regimen (metformin alone, sulphonylurea‐, insulin‐ or incretin‐based therapy). Participants were asked to keep a blood glucose diary and self‐report hypoglycaemia episodes [non‐severe (self‐treated) and severe (requiring external help)] over a 12‐month period. Results Three hundred and twenty‐five participants were enrolled, of whom 274 (84%) returned ≥1 monthly diaries. Overall, 39% reported experiencing hypoglycaemia; 32% recorded ≥1 symptomatic, 36% ≥1 non‐severe, and 7% ≥1 severe episodes. By treatment, incidence (events per person/year) for any hypoglycaemia type was 4.39 for insulin, 2.34 for sulphonylurea, 0.76 for metformin, and 0.56 for incretin‐based therapy. Compared with metformin, risk of non‐severe hypoglycaemia was ~3 times higher for participants on sulphonylureas and > 5 times higher for those on insulin [incidence rate ratio (IRR) 3.02 (1.76‐5.18), P