Pharmacist-Led Continuous Glucose Monitoring for Prediabetes

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT07529366
Status
Recruiting
Apply to this trial

Conditions

  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexcom Stelo CGM — DEVICE
    Subjects included in the intervention group will be recruited from the USF Health Department of Family Medicine. Each subject will be enrolled for 12 weeks. The CGM sensors are worn on the upper arm and changed every 15 days.

Study Details

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. The investigators 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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Change in hemoglobin A1c [ Time Frame: Baseline to End of Study (12 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
USF Health Department of Family Medicine - Morsani Center for Advanced Health CareTampaFlorida33612
Kevin Cowart, PharmD, MPH
[email protected]
813-974-5562
USF Health Department of Family Medicine - University Partnership CenterTampaFlorida33613
Kevin Cowart, PharmD, MPH
[email protected]
813-974-5562

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By research site
USF Health Department of Family Medicine - Morsani Center for Advanced Health Care· Tampa, FLUSF Health Department of Family Medicine - University Partnership Center· Tampa, FL

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