Pharmacist-led Continuous Glucose Monitoring
NCT Number: NCT06572306
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 2 Diabetes
Interventions: DEVICE: FreeStyle Libre 2 Continuous Glucose Monitor
Sponsor: University of South Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-08-05
Locations: USF Health Department of Family Medicine - Morsani Center for Advanced Health Care, Tampa, Florida, 33612, United States|USF Health Department of Family Medicine - University Partnership Center, Tampa, Florida, 33613, United States

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)

Primary Outcome Measures: 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)
Secondary Outcome Measures: 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, 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)