Pharmacist-led Continuous Glucose Monitoring

University of South Florida

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Device: FreeStyle Libre 2 Continuous Glucose Monitor

Study type: Observational

Funder types: Other

Identifiers

NCT06572306

STUDY007451

Details and patient eligibility

About

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)

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Continuous glucose monitoring cohort (intervention)

Description:

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.

Treatment:

Device: FreeStyle Libre 2 Continuous Glucose Monitor

Self-monitoring of blood glucose cohort (historical cohort)

Description:

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).