The Impact of Hypoglycemia on Productivity Loss and Utility in Type 2 Diabetes Patients Treated with Insulin in Real-World Canadian Practice: Protocol for a Prospective Study (Preprint)

BACKGROUND Type 2 diabetes mellitus (T2DM) imposes a significant burden, with its increasing prevalence and life-threatening complications. In patients not achieving glycemic targets on oral antidiabetic drugs, initiation of insulin is recommended. However, a serious concern about insulin is drug-induced hypoglycemia. Hypoglycemia is known to affect quality of life and healthcare resource utilization. However, health economics and outcomes research (HEOR) data for economic modeling are limited, particularly in terms of utility values and productivity losses. OBJECTIVE The aim of this real-world prospective study is to assess the impact of hypoglycemia on productivity and utility in insulin-treated T2DM adults from Ontario and Quebec (Canada). METHODS This noninterventional, multicenter, 3-month prospective study will recruit patients from four medical clinics and two endocrinology/diabetes clinics. Patients will be identified using appointment lists, and enrolled through consecutive sampling during routinely scheduled consultations. To be eligible, patients must be ≥18 years of age, diagnosed with T2DM, and treated with insulin. Utility and productivity will be collected using the EQ-5D-5L questionnaire and the iMTA Productivity Cost Questionnaire (iPCQ), respectively. Questionnaires will be completed at 4, 8 and 12 weeks after recruitment. Generalized estimating equations (GEE) models will be used to investigate productivity losses and utility decrements associated with incident hypoglycemic events while controlling for individual patient characteristics. A total of 500 patients will be enrolled to ensure precision of HEOR estimates. RESULTS This study is designed to fill a gap in the Canadian evidence on the impact of hypoglycemia on HEOR outcomes. More specifically, it will generate productivity and utility inputs for economic modeling in T2DM. CONCLUSIONS Insulin therapies are expensive, and hypoglycemia is a significant component of economic evaluations. Robust HEOR data may help health technology assessment (HTA) agencies in future reimbursement decision making.