Pharmacist-led Continuous Glucose Monitoring

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT06572306
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FreeStyle Libre 2/Libre 3+ Continuous Glucose Monitor — DEVICE
    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.

Study Details

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)

Key Dates

Start date
Sep 1, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Continuous glucose monitoring cohort (intervention)
    Freestyle libre 2 or 3+ sensor devices will be used to monitor glucose. The sensors are worn on the upper arm and changed every 14 (libre 2) or 15 (libre 3+) 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.
  • Arm: 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).

Primary Outcome Measure

Change in hemoglobin A1c [ Time Frame: Baseline to End of Study (12 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
USF Health Department of Family MedicineTampaFlorida33612
Kevin Cowart, PharmD, MPH
[email protected]
813-974-5562

Find similar trials in Tampa, FL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
USF Health Department of Family Medicine· Tampa, FL

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