Pharmacist-Led Continuous Glucose Monitoring for Prediabetes

Redefining Prediabetes Care: Pharmacist-Led Continuous Glucose Monitoring to Drive Lifestyle Change

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.

Study Overview

• Status: Recruiting
• Conditions: Prediabetes
• Intervention / Treatment: Device: Dexcom Stelo CGM

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Kevin Cowart, PharmD, MPH; Phone Number: 813-974-5562; Email: kcowart2@usf.edu
• Study Contact Backup: Name: Raechel White, PharmD; Phone Number: 813-974-1124; Email: rtwhite@usf.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • USF Health Department of Family Medicine - Morsani Center for Advanced Health Care
      • Contact: Kevin Cowart, PharmD, MPH; Phone Number: 813-974-5562; Email: kcowart2@usf.edu
    • Tampa, Florida, United States, 33613
      • Recruiting
      • USF Health Department of Family Medicine - University Partnership Center
      • Contact: Kevin Cowart, PharmD, MPH; Phone Number: 813-974-5562; Email: kcowart2@usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Range	Change in the time in range (70-140 mg/dL) at 4 weeks, %, compared within the intervention cohort	Baseline to End of Week 4 (CGM wear period)
Time in Euglycemic Range	Change in the time in euglycemic range (54-120 mg/dL) at 4 weeks, %, compared within the intervention cohort	Baseline to End of Week 4 (CGM wear period)
Mean Sensor Glucose	Change in mean sensor glucose concentration at 4 weeks, mg/dL, compared within the intervention cohort	Baseline to End of Week 4 (CGM wear period)
Time Below Range	Change in time below range (< 70 mg/dL) at 4 weeks, %, compared within the intervention cohort	Baseline to End of Week 4 (CGM wear period)
Time Above Range	Change in time above range (141-250 mg/dL and > 250 mg/dL) at 4 weeks, %, compared within the intervention cohort	Baseline to End of Week 4 (CGM wear period)
Glycemic Variability	Change in glycemic variability (standard deviation, and Coefficient of variance) at 4 weeks, compared within the intervention cohort	Baseline to End of Week 4 (CGM wear period)
Time in Range Increase 5%	Change in the number of subjects increasing 5% or more in time in range (70-140 mg/dL) at 4 weeks, compared within the intervention cohort	Baseline to End of Week 4 (CGM wear period)
Time in Range Increase 10%	Change in the number of subjects increasing 10% or more in time in range (70-140 mg/dL) at 4 weeks, compared within the intervention cohort	Baseline to End of Week 4 (CGM wear period)
Time in Euglycemic Range Increase 5%	Change in the number of subjects increasing 5% or more in time in euglycemic range (54-120 mg/dL) at 4 weeks, compared within the intervention cohort	Baseline to End of Week 4 (CGM wear period)
Time in Euglycemic Range Increase 10%	Change in the number of subjects increasing 10% or more in time in euglycemic range (54-120 mg/dL) at 4 weeks, compared within the intervention cohort	Baseline to End of Week 4 (CGM wear period)
>70% Time in Range	Change in the number of subjects achieving > 70% time in range (70-140 mg/dL) at 4 weeks, compared within the intervention cohort	Baseline to End of Week 4 (CGM wear period)
>70% Time in Euglycemic Range	Change in the number of subjects achieving > 70% time in euglycemic range (54-120 mg/dL) at 4 weeks, compared within the intervention cohort	Baseline to End of Week 4 (CGM wear period)
Summary of Diabetes Self-Care Activities Measure (SDSCA)	Change in the Summary of Diabetes Self-Care Activities Measure at 12 weeks, compared within the intervention group. Scored on an 8-point likert scale (0-7). Higher scores indicate better compliance with diabetes self-care, whereas a lower score indicate poor self-care performance.	Baseline to End of Study (12 weeks)
Summary of Diabetes Self-Care Activities Measure (SDSCA)	Change in the Summary of Diabetes Self-Care Activities Measure at 4 weeks, compared within the intervention group. Scored on an 8-point likert scale (0-7). Higher scores indicate better compliance with diabetes self-care, whereas a lower score indicate poor self-care performance.	Baseline to End of Week 4 (CGM wear period)
36-Item Short Form Health Survey (SF-36)	Change in the 36-Item Short Form Health Survey (SF-36) Measure at 12 weeks, compared within the intervention group. Produces 8 domain scores and is scored on a 0 to 100 scale. For the standard domain scores, higher scores indicate a more favorable health state. A score of 100 reflects the best health status on that domain, and 0 the worst.	Baseline to End of Study (12 weeks)
36-Item Short Form Health Survey (SF-36)	Change in the 36-Item Short Form Health Survey (SF-36) Measure at 12 weeks, compared within the intervention group. Produces 8 domain scores and is scored on a 0 to 100 scale. For the standard domain scores, higher scores indicate a more favorable health state. A score of 100 reflects the best health status on that domain, and 0 the worst.	Baseline to End of Week 4 (CGM wear period)

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Kevin Cowart, PharmD, MPH, University of South Florida

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: primary care; CGM; pharmacist; prediabetes; continuous glucose monitoring; health behavior; endocrinology; Hemoglobin A1c
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Behavior; Nutritional and Metabolic Diseases; Prediabetic State; Health Behavior
• Other Study ID Numbers: STUDY009771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No