Self-reported Hypoglycaemia in Patients treated with Insulin: A Large Slovenian Retrospectively-prospective Study.

Introduction: Hypoglycaemia is the major barrier for glycaemic target achievement in patients treated with insulin. The aim of the present study was to investigate real-world incidence and predictors of hypoglycaemia in insulin-treated patients.

Methods: More than 300 consecutive patients with type 1 or type 2 diabetes treated with insulin were enrolled during regular out-patient visits from 36 diabetes practices throughout the whole country. They completed a comprehensive questionnaire on hypoglycaemia knowledge, awareness, and incidence in the last month and last six months. In addition, in the prospective part, patients recorded incidence of hypoglycaemic events using a special diary prospectively on a daily basis, through 4 weeks.

Results: At least one hypoglycaemic event was self-reported in 84.1%, and 56.4% of patients with type 1 and type 2 diabetes, respectively, during the prospective period of 4 weeks. 43.4% and 26.2% of patients with type 1 and type 2 diabetes, respectively, experienced a nocturnal hypoglycaemic event. In the same time-period, severe hypoglycaemia was experienced by 15.9% and 7.1% of patients with type 1 and type 2 diabetes, respectively. Lower glycated haemoglobin was not a significant predictor of hypoglycaemia.

Conclusions: Rates of self-reported hypoglycaemia in patients treated with insulin in the largest and most comprehensive study in Slovenia so far are higher than reported from randomised control trials, but comparable to data from observational studies. Hypoglycaemia incidence was high even with high glycated haemoglobin values.