Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, endocrine disorders, continuous glucose monitor, pharmacist
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)
Interventions
DEVICEFreeStyle Libre 2/Libre 3+ Continuous Glucose Monitor
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.
Sponsors
University of South Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes * hemoglobin A1c ≥ 8% * compatible smartphone with FreeStyle Libre 2 or Libre 3+ continuous glucose monitoring system * current use and access to a glucometer for self-monitoring of blood glucose
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| >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 |
| 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 |
| 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. |
| Continuous Glucose Monitoring Survey Responses | Baseline to End of Study (12 weeks) | Change in survey responses at 12 weeks, compared within the intervention group |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKevin Cowart, PharmD, MPH
University of South Florida
Outcome results
None listed