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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Cowart, PharmD, MPH | Contact | 813-974-5562 | kcowart2@usf.edu | |
| Raechel White, PharmD | Contact | 813-974-1124 | rtwhite@usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kevin Cowart, PharmD, MPH | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USF Health Department of Family Medicine - Morsani Center for Advanced Health Care | Recruiting | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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) |
| USF Health Department of Family Medicine - University Partnership Center | Recruiting | Tampa | Florida | 33613 | United States |
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| D004700 | Endocrine System Diseases |
| D001519 | Behavior |