Investigating the Impact of Pharmacist-led Flash Continuous Glucose Monitoring on Clinical and Behavioral Health Outcomes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
USF Health Department of Family Medicine - Morsani Center for Advanced Health Care
RECRUITING
Tampa
USF Health Department of Family Medicine - University Partnership Center
RECRUITING
Tampa
Contact Information
Primary
Kevin Cowart, PharmD, MPH
kcowart2@usf.edu
813-974-5562
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2025-08-05
Participants
Target number of participants: 20
Treatments
Continuous glucose monitoring cohort (intervention)
Freestyle libre 2 sensor devices will be used to monitor glucose. The sensors are worn on the upper arm and changed every 14 days. Each subject will have 5 visits with a pharmacist over 12 weeks. Subjects meeting inclusion criteria will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8%. Subjects must have a compatible smartphone with the freestyle libre 2 sensor system. Subjects must have access to a glucometer to check blood glucose. Subjects must not have worn a continuous glucose monitor in the last 6 months to be eligible.
Self-monitoring of blood glucose cohort (historical cohort)
A retrospective chart review will be performed on patients seen by a clinic pharmacist between 1/1/2020-7/1/2024. Subjects in this group will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8% and using a glucometer to monitor blood sugar. Exclusion criteria will be use of any continuous glucose monitoring device within the prior 6 months of the index date (defined as first visit with a pharmacist during study time frame).
Related Therapeutic Areas
Sponsors
Leads: University of South Florida

This content was sourced from clinicaltrials.gov