Incidence and Correlates of Hypoglycemia in Type 2 Diabetes. The Hypos-1 Study

Background: To evaluate the incidence of severe and symptomatic hypoglycemia in type 2 diabetes and identify their correlates. Materials and methods: HYPOS-1 is an observational retrospective study. Socio-demographic and clinical characteristics, experience of severe hypoglycemia in the past 12 months and experience of symptomatic hypoglycemia in the past 4 weeks were recorded through a patient questionnaire and a clinical record form. Poisson multivariate models were applied. Results: Overall, 2023 patients were involved by 18 diabetes clinics. Incidence rate (IR) of severe hypoglycemia was of 0.09 events/person-years; IR of symptomatic hypoglycemia was of 9.30 events/person-years. A minority of patients accounted for the vast majority of severe episodes. The risk of severe hypoglycemia was three times higher in patients with previous severe (Incidence Rate Ratio: 3.38; 95% confidence interval:2.47-4.62) and symptomatic hypoglycemia (IRR 3.05; 95% CI 2.18-4.26); a two-fold risk of severe episodes was associated with basal-bolus insulin regimen (IRR 2.04; 95% CI 1.24-3.35) as compared with oral therapies not including secretagogues. Glucose-lowering therapy (i.e. secretagogues and insulin) and previous severe hypoglycemia represented the strongest predictors of symptomatic hypoglycemia. Female gender was associated with a two-fold risk of severe and a 44% higher risk of symptomatic episodes as compared to male gender. Age, diabetes duration, HbA1c, neuropathy, retinopathy, overall number of drugs, neoplasms, living status and employment status also increased the risk of severe and/or symptomatic episodes. Discussion: Hypoglycemia still represents a common acute complication for individuals with type 2 diabetes. Identifying patients at higher risk is a key strategy to reduce the burden of hypoglycemia.