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: 1. Determine impact of pharmacist-led CGM on glycemic control in people with prediabetes. Researchers will compare change in hemoglobin A1c at 12 weeks with pharmacist-led CGM versus a historical cohort of subjects with prediabetes receiving no CGM. We will also assess change in CGM-derived glycemic metrics from baseline to end of the CGM wear period in the intervention group. 2. Evaluate impact of pharmacist-led CGM on health behavior change in people with prediabetes in the intervention group. Participants will be asked to complete the Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF-36) at baseline, at the end of week 4, and at the end of the study so that researchers can measure the effects in the intervention group on health behavior change.
Study Type
OBSERVATIONAL
Enrollment
40
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.
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 (70-140 mg/dL) at 4 weeks, %, compared within the intervention cohort
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to End of Week 4 (CGM wear period)
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