Recruiting

Pharmacist-led CGM

Sponsor:

University of South Florida

Code:

NCT07529366

Conditions

Prediabetes

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Dexcom Stelo CGM

Study Details

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.

Conditions

Prediabetes

Study ID

NCT07529366

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Dexcom Stelo CGM

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kevin Cowart, PharmD, MPH

813-974-5562kcowart2@usf.edu

Raechel White, PharmD

813-974-1124rtwhite@usf.edu

Locations

USF Health Department of Family Medicine - Morsani Center for Advanced Health Care

Recruiting

Tampa, Florida, United States, 33612

Contacts

Kevin Cowart, PharmD, MPH

813-974-5562kcowart2@usf.edu

USF Health Department of Family Medicine - University Partnership Center

Recruiting

Tampa, Florida, United States, 33613

Contacts

Kevin Cowart, PharmD, MPH

813-974-5562kcowart2@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • prediabetes
  • continuous glucose monitoring
  • pharmacist
  • health behavior
  • Hemoglobin A1c
  • endocrinology
  • primary care
  • CGM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-08-10.