Pharmacist-Led Continuous Glucose Monitoring for Prediabetes

Browse trials for

• Prediabetic State 996
• Health Behavior 224

Keywords

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

Study population

Groups and cohorts

• 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

• DeviceDexcom 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 outcomes

1. Change in hemoglobin A1c

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

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

Secondary outcomes

1. Time in Range

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

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

2. Time in Euglycemic Range

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

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

3. Mean Sensor Glucose

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

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

4. Time Below Range

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

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

5. Time Above Range

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

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

6. Glycemic Variability

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

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

7. 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

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

8. 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

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

9. 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

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

10. 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

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

11. >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

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

12. >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

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

13. 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.

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

14. 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.

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

15. 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.

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

16. 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.

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

Individual participant data

Plan to share: No