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)
Study Type
OBSERVATIONAL
Enrollment
20
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.
USF Health Department of Family Medicine - Morsani Center for Advanced Health Care
Tampa, Florida, United States
RECRUITINGUSF Health Department of Family Medicine - University Partnership Center
Tampa, Florida, United States
RECRUITINGChange 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)
Time in Range
Change in the time in range (70-180 mg/dL) at 12 weeks, %, compared within the intervention cohort
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline to End of Study (12 weeks)
Continuous Glucose Monitoring Survey Responses
Change in survey responses at 12 weeks, compared within the intervention group
Time frame: Baseline to End of Study (12 weeks)
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