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NCT Number: NCT07529366

Pharmacist-Led Continuous Glucose Monitoring for Prediabetes

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.

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Key information

Conditions

PreDiabetes Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

USF Health Department of Family Medicine - Morsani Center for Advanced Health Care, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in hemoglobin A1c

    Time frame: Baseline to End of Study (12 weeks)

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

Secondary outcomes

  1. Time in Range

    Time frame: Baseline to End of Week 4 (CGM wear period)

    Change in the time in range (70-140 mg/dL) at 4 weeks, %, compared within the intervention cohort

  2. Time in Euglycemic Range

    Time frame: Baseline to End of Week 4 (CGM wear period)

    Change in the time in euglycemic range (54-120 mg/dL) at 4 weeks, %, compared within the intervention cohort

  3. Mean Sensor Glucose

    Time frame: Baseline to End of Week 4 (CGM wear period)

    Change in mean sensor glucose concentration at 4 weeks, mg/dL, compared within the intervention cohort

  4. Time Below Range

    Time frame: Baseline to End of Week 4 (CGM wear period)

    Change in time below range (< 70 mg/dL) at 4 weeks, %, compared within the intervention cohort

  5. Time Above Range

    Time frame: Baseline to End of Week 4 (CGM wear period)

    Change in time above range (141-250 mg/dL and > 250 mg/dL) at 4 weeks, %, compared within the intervention cohort

  6. Glycemic Variability

    Time frame: Baseline to End of Week 4 (CGM wear period)

    Change in glycemic variability (standard deviation, and Coefficient of variance) at 4 weeks, compared within the intervention cohort

  7. Time in Range Increase 5%

    Time frame: Baseline to End of Week 4 (CGM wear period)

    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

  8. Time in Range Increase 10%

    Time frame: Baseline to End of Week 4 (CGM wear period)

    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

  9. Time in Euglycemic Range Increase 5%

    Time frame: Baseline to End of Week 4 (CGM wear period)

    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

  10. Time in Euglycemic Range Increase 10%

    Time frame: Baseline to End of Week 4 (CGM wear period)

    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

  11. >70% Time in Range

    Time frame: Baseline to End of Week 4 (CGM wear period)

    Change in the number of subjects achieving > 70% time in range (70-140 mg/dL) at 4 weeks, compared within the intervention cohort

  12. >70% Time in Euglycemic Range

    Time frame: Baseline to End of Week 4 (CGM wear period)

    Change in the number of subjects achieving > 70% time in euglycemic range (54-120 mg/dL) at 4 weeks, compared within the intervention cohort

  13. Summary of Diabetes Self-Care Activities Measure (SDSCA)

    Time frame: Baseline to End of Study (12 weeks)

    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.

  14. Summary of Diabetes Self-Care Activities Measure (SDSCA)

    Time frame: Baseline to End of Week 4 (CGM wear period)

    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.

  15. 36-Item Short Form Health Survey (SF-36)

    Time frame: Baseline to End of Study (12 weeks)

    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.

  16. 36-Item Short Form Health Survey (SF-36)

    Time frame: Baseline to End of Week 4 (CGM wear period)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Cowart, PharmD, MPH

CONTACT

[email protected]

813-974-5562

Raechel White, PharmD

CONTACT

[email protected]

813-974-1124

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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