NCT07529366 Pharmacist-Led Continuous Glucose Monitoring for Prediabetes
| NCT ID | NCT07529366 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Florida |
| Condition | Prediabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2026-09-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Kevin Cowart, PharmD, MPH
PRINCIPAL INVESTIGATOR
University of South Florida
Frequently Asked Questions
Who can join the NCT07529366 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Prediabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07529366 currently recruiting?
Yes, NCT07529366 is actively recruiting participants. Contact the research team at kcowart2@usf.edu for enrollment information.
Where is the NCT07529366 trial being conducted?
This trial is being conducted at Tampa, United States, Tampa, United States.
Who is sponsoring the NCT07529366 clinical trial?
NCT07529366 is sponsored by University of South Florida. The principal investigator is Kevin Cowart, PharmD, MPH at University of South Florida. The trial plans to enroll 40 participants.
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