Pharmacist-led Continuous Glucose Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Community Health Worker/Pharmacist Team to Improve Blood Sugars in Diabetes Care Using Continuous Glucose Monitoring

NCT05911256

Type 2 Diabetes

ENROLLING_BY_INVITATION NA

Pharmacist-driven CGM Use in the Uninsured Population

NCT03477838

Diabetes Mellitus

COMPLETED NA

Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes

NCT04843527

Diabetes Mellitus, Type 2

ACTIVE_NOT_RECRUITING NA

Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System

NCT03411460

Insulin-Dependent Diabetes

TERMINATED NA

Optimal Metabolic Health Through Continuous Glucose Monitoring

NCT04920058

Metabolic Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

FreeStyle Libre 2 Continuous Glucose Monitor

Intervention Type 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.

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).

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FreeStyle Libre 2 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No