Towards an improved global understanding of treatment and outcomes in people with type 2 diabetes: Rationale and methods of the DISCOVER observational study program

Abstract

Aim: Contemporary global real-world data on the management of type 2 diabetes are scarce. The global DISCOVER study program aims to describe the disease management patterns and a broad range of associated outcomes in patients with type 2 diabetes initiating a second-line glucose-lowering therapy in routine clinical practice.

Methods: The DISCOVER program comprises two longitudinal observational studies involving more than 15,000 patients in 38 countries across six continents. Study sites have been selected to be representative of type 2 diabetes management in each country. Data will be collected at baseline (initiation of second-line therapy), at 6months, and yearly during a 3-year follow-up period.

Results: The DISCOVER program will record patient, healthcare provider, and healthcare system characteristics, treatment patterns, and factors influencing changes in therapy. In addition, disease control (e.g. achievement of glycated hemoglobin target), management of associated risk factors (e.g. hypercholesterolemia and hypertension), and healthcare resource utilization will be recorded. Microvascular and macrovascular complications, incidence of hypoglycemic events, and patient-reported outcomes will also be captured.

Conclusions: The DISCOVER program will provide insights into the current management of patients with type 2 diabetes worldwide, which will contribute to informing future clinical guidelines and improving patient care.

Keywords: Longitudinal observational study; Outcomes; Real-world evidence; Second-line therapy; Treatment patterns; Type 2 diabetes.