Pharmacist-led continuous glucose monitoring for people with prediabetes
Redefining Prediabetes Care: Pharmacist-Led Continuous Glucose Monitoring to Drive Lifestyle Change
Pharmacists will try continuous glucose monitoring to see if it improves blood sugar and health habits in adults with prediabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of South Florida Academic / other |
| Locations | 2 sites (Tampa, Florida and 1 other locations) |
| Trial ID | NCT07529366 on ClinicalTrials.gov |
What this trial studies
This observational program uses pharmacist-led wearable continuous glucose monitoring (Dexcom Stelo) in adults with prediabetes and compares outcomes to a historical cohort without CGM. The primary metabolic endpoint is change in hemoglobin A1c at 12 weeks, and investigators will also compare CGM-derived glycemic metrics from baseline to the end of the wear period in the intervention group. Health behavior and quality-of-life changes will be measured with the Summary of Diabetes Self-Care Activities (SDSCA) and the SF-36 at baseline, week 4, and study end. Participants must be 18–70 years old, have prediabetes-range A1c, and a smartphone compatible with the Dexcom Stelo system.
Who should consider this trial
Good fit: Adults aged 18–70 with prediabetes (HbA1c 5.7–6.4%), who have not used CGM in the prior 6 months and have a smartphone compatible with the Dexcom Stelo system, are the intended participants.
Not a fit: People with diagnosed diabetes, recent problematic hypoglycemia, pregnancy, planned dialysis, or no compatible smartphone are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could help people with prediabetes lower average glucose levels and adopt healthier self-care behaviors earlier.
How similar studies have performed: Previous CGM studies in people with diabetes and at-risk adults have shown behavior change and improved glycemic metrics, but pharmacist-led CGM specifically in prediabetes remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adults 18-70 years of age * prediabetes (HbA1c 5.7-6.4%) * compatible smartphone with the Dexcom Stelo sensor system * have not have worn a CGM in the last 6 months prior to enrollment Exclusion Criteria: * any of the following forms of diabetes: type 1 diabetes, type 2 diabetes, monogenic diabetes, cystic fibrosis-related diabetes, post- transplant diabetes, latent autoimmune diabetes * problematic hypoglycemia in the prior 6 months \[defined as recurrent (more than one) level 2 hypoglycemic events (glucose \<54mg/dL ) that persist despite multiple attempts to adjust medication(s) and/or modify the diabetes/treatment plan or a history of one level 3 hypoglycemic event (glucose \<54mg/dL) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia\] * pregnant, or planning to become pregnant during the study time frame * currently receiving or planned to receive dialysis during the study time frame - current use of systemic steroids for any condition * a known allergy to medical grade adhesives, * use of any CGM device in the past 6 months * history of a diagnosed eating disorder * current use of a second-generation antipsychotic at the time of consent (aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone) * subjects lacking capacity to provide informed consent
Where this trial is running
Tampa, Florida and 1 other locations
- USF Health Department of Family Medicine - Morsani Center for Advanced Health Care — Tampa, Florida, United States (Recruiting)
- USF Health Department of Family Medicine - University Partnership Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Kevin Cowart, PharmD, MPH — University of South Florida
- Study coordinator: Kevin Cowart, PharmD, MPH
- Email: kcowart2@usf.edu
- Phone: 813-974-5562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.