What this study is
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.
What's being tested
- Dexcom Stelo CGM
Intervention · 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
- Official title
- Redefining Prediabetes Care: Pharmacist-Led Continuous Glucose Monitoring to Drive Lifestyle Change
- Sponsor
- University of South Florida
- Conditions
- Prediabetes
- Enrolling
- 40 people
- Starts
- 2026-10-06
- Est. completion
- 2027-07-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openContact for every open site
- Kevin Cowart, PharmD, MPH · Contact813-974-5562kcowart2@usf.edu
USF Health Department of Family Medicine - Morsani Center for Advanced Health Care
Tampa, Florida, United States
RecruitingUSF Health Department of Family Medicine - University Partnership Center
Tampa, Florida, United States
Recruiting
Study team
Sponsor
University of South Florida
Study ID STUDY009771
Principal investigator
Kevin Cowart, PharmD, MPH
University of South Florida
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.