The Canadian Hypoglycemia Assessment Tool Program: Insights Into Rates and Implications of Hypoglycemia From an Observational Study.

Objective: The true prevalence of hypoglycemia in insulin-treated patients with diabetes and its impact on patients, employers and healthcare providers is poorly appreciated owing to a paucity of real-world data. The global Hypoglycemia Assessment Tool (HAT) study addressed this issue, and here we report data from the Canadian cohort of patients.

Methods: This noninterventional, 6-month retrospective and 4-week prospective study enrolled patients aged ≥18 years receiving insulin treatment for >12 months from community endocrinology practices. Data were collected using self-assessment questionnaires and patient diaries. The primary endpoint was the proportion of patients experiencing ≥1 hypoglycemic event during the 4-week prospective observational period.

Results: Four hundred ninety-eight patients with type 1 diabetes (n=183) and type 2 diabetes (n=315) were enrolled. The prevalence of hypoglycemia was similar in the retrospective (type 1 diabetes, 92.3%; type 2 diabetes, 63.5%) and prospective (type 1 diabetes, 95.2%; type 2 diabetes, 64.2%) periods. Prospective rates of any, nocturnal and severe hypoglycemia per patient-year (95% confidence interval) were 69.3 (66.4; 72.2), 14.2 (12.9; 15.6) and 1.8 [1.4; 2.4]. Higher rates were reported retrospectively, reaching significance for nocturnal hypoglycemia per patient-year (30.0 [28.1; 32.0] vs. 14.2 [12.9; 15.6]; p<0.001). Hypoglycemia led to increased healthcare utilization and absenteeism and was associated with potentially harmful self-care behaviours (e.g., reduced or skipped insulin doses) and increased blood glucose self-monitoring.

Conclusions: Prevalence and incidence of hypoglycemia were high among insulin-treated patients with diabetes in Canada, and some patients took harmful or costly actions when they experienced hypoglycemia. Identifying the insulin-treated patients who are at greatest risk may help to reduce the incidence of hypoglycemia.