Clinical trial NCT06572306: Pharmacist-led Continuous Glucose Monitoring
Official title: Investigating the Impact of Pharmacist-led Flash Continuous Glucose Monitoring on Clinical and Behavioral Health Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
endocrine disorders
continuous glucose monitor
pharmacist
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 2 diabetes with hemoglobin A1c ≥ 8%

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)


Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Change in hemoglobin A1c
timeFrame: Baseline to End of Study (12 weeks)
Secondary outcomes:
measure: Time in Range
timeFrame: Baseline to End of Study (12 weeks)
measure: Mean Sensor Glucose
timeFrame: Baseline to End of Study (12 weeks)
measure: Time Below Range
timeFrame: Baseline to End of Study (12 weeks)
measure: Time Above Range
timeFrame: Baseline to End of Study (12 weeks)
measure: Glycemic Variability
timeFrame: Baseline to End of Study (12 weeks)
measure: Time in Range Increase 5%
timeFrame: Baseline to End of Study (12 weeks)
measure: Time in Range Increase 10%
timeFrame: Baseline to End of Study (12 weeks)
measure: >70% Time in Range
timeFrame: Baseline to End of Study (12 weeks)
measure: Hemoglobin A1c <7%
timeFrame: Baseline to End of Study (12 weeks)
measure: Hemoglobin A1c <8%
timeFrame: Baseline to End of Study (12 weeks)
measure: Summary of Diabetes Self-Care Activities Measure
timeFrame: Baseline to End of Study (12 weeks)
measure: Continuous Glucose Monitoring Survey Responses
timeFrame: Baseline to End of Study (12 weeks)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Health Department of Family Medicine - Morsani Center for Advanced Health Care
state: Florida
city: Tampa
country: United States
facility: USF Health Department of Family Medicine - University Partnership Center
state: Florida
Study officials:
affiliation: University of South Florida
name: Kevin Cowart, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
References: