Pharmacist-Led Continuous Glucose Monitoring for Prediabetes

NCT07529366 | Recruiting DMC FDA Device

• 1 other identifier: STUDY009771
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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. 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. 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin A1c

  Between-group difference in change in hemoglobin A1c at 12 weeks, %, compared between intervention and historical cohort

  Baseline to End of Study (12 weeks)

Secondary Outcomes (16)

• Time in Range

  Baseline to End of Week 4 (CGM wear period)

• Time in Euglycemic Range

  Baseline to End of Week 4 (CGM wear period)

• Mean Sensor Glucose

  Baseline to End of Week 4 (CGM wear period)

• Time Below Range

  Baseline to End of Week 4 (CGM wear period)

• Time Above Range

  Baseline to End of Week 4 (CGM wear period)

Study Arms (2)

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.

Device: Dexcom Stelo CGM

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 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.

CGM Cohort (Intervention)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%)

You 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 may not qualify 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (2)

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

Tampa, Florida, 33612, United States

RECRUITING

USF Health Department of Family Medicine - University Partnership Center

Tampa, Florida, 33613, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Health Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Kevin Cowart, PharmD, MPH

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Cowart, PharmD, MPH

CONTACT

813-974-5562; kcowart2@usf.edu

Raechel White, PharmD

CONTACT

813-974-1124; rtwhite@usf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)