Real-world crude incidence of hypoglycemia in adults with diabetes: Results of the InHypo-DM Study, Canada.

Objective: Very few real-world studies have been conducted to assess the incidence of diabetes-related hypoglycemia. Moreover, there is a paucity of studies that have investigated hypoglycemia among people taking secretagogues as a monotherapy or in combination with insulin. Accordingly, our research team developed and validated the InHypo-DM Person with Diabetes Mellitus Questionnaire (InHypo-DMPQ) with the aim of capturing the real-world incidence of self-reported, symptomatic hypoglycemia. The questionnaire was administered online to a national sample of Canadians (≥18 years old) with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) treated with insulin and/or insulin secretagogues.

Research design and methods: Self-report data obtained from the InHypo-DMPQ were descriptively analyzed to ascertain the crude incidence proportions and annualized incidence densities (rates) of 30-day retrospective non-severe and 1-year retrospective severe hypoglycemia, including daytime and nocturnal events.

Results: A total of 552 people (T2DM: 83%; T1DM: 17%) completed the questionnaire. Over half (65.2%) of the total respondents reported experiencing at least one event (non-severe or severe) at an annualized crude incidence density of 35.1 events per person-year. The incidence proportion and rate of non-severe events were higher among people with T1DM versus T2DM (77% and 55.7 events per person-year vs 54% and 28.0 events per person-year). Severe hypoglycemia was reported by 41.8% of all respondents, at an average rate of 2.5 events per person-year.

Conclusions: The results of the InHypo-DMPQ, the largest real-world investigation of hypoglycemia epidemiology in Canada, suggest that the incidence of hypoglycemia among adults with diabetes taking insulin and/or insulin secretagogues is higher than previously thought.