Pharmacist-Led Continuous Glucose Monitoring for Prediabetes
Purpose
The goal of this observational study is to determine if a pharmacist-led program involving continuous glucose monitoring (CGM) improves glucose control and health behavior in people with prediabetes. The main questions it aims to answer are: 1. Determine impact of pharmacist-led CGM on glycemic control in people with prediabetes. Researchers will compare change in hemoglobin A1c at 12 weeks with pharmacist-led CGM versus a historical cohort of subjects with prediabetes receiving no CGM. We will also assess change in CGM-derived glycemic metrics from baseline to end of the CGM wear period in the intervention group. 2. Evaluate impact of pharmacist-led CGM on health behavior change in people with prediabetes in the intervention group. Participants will be asked to complete the Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF-36) at baseline, at the end of week 4, and at the end of the study so that researchers can measure the effects in the intervention group on health behavior change.
Condition
- Prediabetes
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 - 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| CGM Cohort (Intervention) | Subjects meeting inclusion criteria will include adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%) obtained within the six months preceding enrollment. Subjects must have a compatible smartphone with the Dexcom CGM sensor system. Subjects must not have worn a CGM in the last 6 months to be eligible. |
|
| No CGM Cohort (Retrospective Cohort) | A retrospective chart review will be performed on patients seen at the USF Health Department of Family Medicine between 1/1/2025-03/20/2026. Subjects in this group will include adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%). Subjects in this cohort will have not received CGM. |
|
Recruiting Locations
Tampa, Florida 33612
Tampa, Florida 33613
More Details
- Status
- Recruiting
- Sponsor
- University of South Florida