Pharmacist-led Continuous Glucose Monitoring
- Conditions
- Type 2 Diabetes
- Interventions
- Device: FreeStyle Libre 2 Continuous Glucose Monitor
- Registration Number
- NCT06572306
- Lead Sponsor
- University of South Florida
- Brief Summary
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:
1. to assess change in hemoglobin A1c in people with type 2 diabetes using continuous glucose monitoring under a pharmacist-led approach as compared to a pharmacist-led approach utilizing no continuous glucose monitoring (only self-monitoring blood glucose with a glucometer).
2. to assess change in continuous glucose monitoring-derived glycemic outcomes among the pharmacist-led continuous glucose monitoring cohort (intervention group)
3. to assess change in health behavior among the pharmacist-led continuous glucose monitoring cohort (intervention group)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- type 2 diabetes
- hemoglobin A1c ≥ 8%
- compatible smartphone with FreeStyle Libre 2 continuous glucose monitoring system
- current use and access to a glucometer for self-monitoring of blood glucose
- any continuous glucose monitor use within 6 months prior to study enrollment
- pregnant and planning to become pregnant during study time frame
- history of hypoglycemia requiring third party assistance
- history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to study enrollment
- known allergy to medical grade adhesives
- current use of systemic steroids for any medical condition
- current use of dialysis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Continuous glucose monitoring cohort (intervention) FreeStyle Libre 2 Continuous Glucose Monitor Freestyle libre 2 sensor devices will be used to monitor glucose. The sensors are worn on the upper arm and changed every 14 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.
- Primary Outcome Measures
Name Time Method Change in hemoglobin A1c 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 Outcome Measures
Name Time Method Hemoglobin A1c <7% Baseline to End of Study (12 weeks) Change in the number of subjects achieving hemoglobin A1c \< 7% at 12 weeks compared between intervention and historical cohort
Time in Range Baseline to End of Study (12 weeks) Change in the time in range (70-180 mg/dL) at 12 weeks, %, compared within the intervention cohort
Mean Sensor Glucose Baseline to End of Study (12 weeks) Change in mean sensor glucose concentration at 12 weeks, mg/dL, compared within the intervention cohort
Time Below Range Baseline to End of Study (12 weeks) Change in time below range (\< 54mg/dL and \< 70 mg/dL) at 12 weeks, %, compared within the intervention cohort
Time Above Range Baseline to End of Study (12 weeks) Change in time above range (\> 180 mg/dL and \> 250 mg/dL) at 12 weeks, %, compared within the intervention cohort
Time in Range Increase 5% Baseline to End of Study (12 weeks) 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
Time in Range Increase 10% Baseline to End of Study (12 weeks) 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
Hemoglobin A1c <8% Baseline to End of Study (12 weeks) Change in the number of subjects achieving hemoglobin A1c \< 8% at 12 weeks compared between intervention and historical cohort
Summary of Diabetes Self-Care Activities Measure 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.
Glycemic Variability Baseline to End of Study (12 weeks) Change in glycemic variability (standard deviation, and Coefficient of variance) at 12 weeks, compared within the intervention cohort
>70% Time in Range Baseline to End of Study (12 weeks) Change in the number of subjects achieving \> 70% time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort
Continuous Glucose Monitoring Survey Responses Baseline to End of Study (12 weeks) Change in survey responses at 12 weeks, compared within the intervention group
Trial Locations
- Locations (2)
USF Health Department of Family Medicine - Morsani Center for Advanced Health Care
🇺🇸Tampa, Florida, United States
USF Health Department of Family Medicine - University Partnership Center
🇺🇸Tampa, Florida, United States