The glucose monitoring comparison in primary care study (GluCoCare): Study design, methods, recruitment success, and baseline characteristics of study participants.

BACKGROUND

While both fingerstick blood glucose monitoring (BGM) and continuous glucose monitoring (CGM) are currently available for people managing type 2 diabetes (T2D) with insulin, it is not currently known which is more effective in optimizing glycemia and decreasing disease burden in this population in real-world settings.

OBJECTIVES

This two-arm cluster-randomized trial will compare use of BGM versus CGM in individuals with T2D using insulin not meeting A1C goals. We will compare change in hemoglobin A1c (A1C) (primary outcome measure) and Diabetes Distress Scale score (DDS) (secondary outcome measure) in individuals attending primary care clinics randomized to either BGM or CGM monitoring over 12 months.

MATERIALS AND

METHODS

Fifty clinics in a large healthcare system in Minnesota and Wisconsin were randomized to enroll individuals to monitor with BGM (25 clinics) or CGM (25 clinics). Adults aged 18-75 with T2D using insulin, A1C 7.5-12%, were recruited from these clinics to be managed by their primary care clinician in a fundamentally pragmatic intervention over 12 months. A1C, DDS, and blinded CGM along with patient reported outcome (PRO) measures will be compared between 0 and 12 months.

RESULTS

GluCoCare met its enrollment goals, enrolling 360 individuals from 42 primary care clinics between September 2022 and June 2024, age (mean ± SD) 60.5 ± 10.3 years, diabetes duration 14.3 ± 8.2 years, A1C 8.8% ± 1.1%, and DDS 2.2 ± 0.9.

CONCLUSIONS

We have successfully enrolled participants with T2D using insulin, to test in a real-world primary care setting, whether BGM versus CGM improves A1c or decreases Diabetes Distress Scale score more.