Pharmacist-Led Continuous Glucose Monitoring for Prediabetes: Protocol for a Prospective Cohort Study

BACKGROUND: Prediabetes represents a critical intervention window to reduce progression to type 2 diabetes. The current standard of care for treatment of prediabetes is weight loss and lifestyle modification, which are both highly effective, although limited by real-world adherence. It is well recognized that continuous glucose monitoring (CGM) improves glycemic and behavioral outcomes in people with diabetes, although outcomes among people with prediabetes are not well described. OBJECTIVE: The aim of this study is to evaluate the impact of pharmacist-led CGM on glycemic control and health-related behaviors in adults with prediabetes. METHODS: This study includes a prospective pharmacist-led CGM cohort and a matched retrospective usual-care cohort. Adults aged 18 to 70 years with prediabetes (hemoglobin A1c [HbA1c] 5.7%-6.4%) will be eligible for the prospective cohort if they have a compatible smartphone and no CGM use in the prior 6 months. Participants will receive CGM (Stelo glucose biosensor; Dexcom) and diabetes self-management education and support over 12 weeks. The primary outcome is the change in HbA1c at 12 weeks, compared between groups. Secondary outcomes include CGM-derived metrics, changes in Summary of Diabetes Self-Care Activities scores and 36-Item Short Form Health Survey scores, and CGM-related adverse effects. RESULTS: This study was funded in 2026. Recruitment is ongoing, and no participants had been enrolled at the time of writing. The planned sample size is 40 participants: 20 prospective CGM participants and 20 retrospective controls. Outcome data are not yet available. The study is expected to be completed in July 2027, and the results are anticipated to be disseminated in December 2027. CONCLUSIONS: This study seeks to evaluate the glycemic impact, behavior change, and safety of pharmacist-led CGM for prediabetes in primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT07529366; https://tinyurl.com/33bv7u8c. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/105275.