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This is a pilot study. The goal of this prospective cohort study is to determine impact of pharmacist-led continuous glucose monitoring on glycemic control and health behavior change in people with type 2 diabetes. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous glucose monitoring cohort (intervention) | Freestyle libre 2 or 3+ sensor devices will be used to monitor glucose. The sensors are worn on the upper arm and changed every 14 (libre 2) or 15 (libre 3+) days. Each subject will have 5 visits with a pharmacist over 12 weeks. Subjects meeting inclusion criteria will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8%. Subjects must have a compatible smartphone with the freestyle libre 2 sensor system. Subjects must have access to a glucometer to check blood glucose. Subjects must not have worn a continuous glucose monitor in the last 6 months to be eligible. |
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| Self-monitoring of blood glucose cohort (historical cohort) | A retrospective chart review will be performed on patients seen by a clinic pharmacist between 1/1/2020-7/1/2024. Subjects in this group will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8% and using a glucometer to monitor blood sugar. Exclusion criteria will be use of any continuous glucose monitoring device within the prior 6 months of the index date (defined as first visit with a pharmacist during study time frame). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libre 2/Libre 3+ Continuous Glucose Monitor | Device | Subjects included in the intervention group (continuous glucose monitoring) will be recruited from the USF Health Department of Family Medicine. Each subject will be enrolled for 12 weeks. |
| 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 (70-180 mg/dL) at 12 weeks, %, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
| Mean Sensor Glucose | Change in mean sensor glucose concentration at 12 weeks, mg/dL, compared within the intervention cohort |
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Inclusion Criteria:
Exclusion Criteria:
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type 2 diabetes with hemoglobin A1c ≥ 8%
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Cowart, PharmD, MPH | Contact | 813-974-5562 | kcowart2@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 | Recruiting | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40409747 | Derived | Cowart K, White RT, Olson K, Carris NW, Hanna K, Zgibor J. Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 May 23;14:e67014. doi: 10.2196/67014. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D004700 | Endocrine System Diseases |
| 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 Study (12 weeks) |
| Time Below Range | Change in time below range (< 54mg/dL and < 70 mg/dL) at 12 weeks, %, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
| Time Above Range | Change in time above range (> 180 mg/dL and > 250 mg/dL) at 12 weeks, %, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
| Glycemic Variability | Change in glycemic variability (standard deviation, and Coefficient of variance) at 12 weeks, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
| Time in Range Increase 5% | Change in the number of subjects increasing 5% or more in time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
| Time in Range Increase 10% | Change in the number of subjects increasing 10% or more in time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
| >70% Time in Range | Change in the number of subjects achieving > 70% time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
| Hemoglobin A1c <7% | Change in the number of subjects achieving hemoglobin A1c < 7% at 12 weeks compared between intervention and historical cohort | Baseline to End of Study (12 weeks) |
| Hemoglobin A1c <8% | Change in the number of subjects achieving hemoglobin A1c < 8% at 12 weeks compared between intervention and historical cohort | Baseline to End of Study (12 weeks) |
| Summary of Diabetes Self-Care Activities Measure | 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) |
| Continuous Glucose Monitoring Survey Responses | Change in survey responses at 12 weeks, compared within the intervention group | Baseline to End of Study (12 weeks) |