Pharmacist-led Continuous Glucose Monitoring

NCT06572306 | Recruiting DMC FDA Device

• 1 other identifier: STUDY007451
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 2.to assess change in continuous glucose monitoring-derived glycemic outcomes among the pharmacist-led continuous glucose monitoring cohort (intervention group)
3. 3.to assess change in health behavior among the pharmacist-led continuous glucose monitoring cohort (intervention group)

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; endocrine disorders; continuous glucose monitor; pharmacist

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin A1c

  Between-group difference in change in hemoglobin A1c at 12 weeks, %, compared between intervention and historical cohort

  Baseline to End of Study (12 weeks)

Secondary Outcomes (12)

• Time in Range

  Baseline to End of Study (12 weeks)

• Mean Sensor Glucose

  Baseline to End of Study (12 weeks)

• Time Below Range

  Baseline to End of Study (12 weeks)

• Time Above Range

  Baseline to End of Study (12 weeks)

• Glycemic Variability

  Baseline to End of Study (12 weeks)

Study Arms (2)

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.

Device: FreeStyle Libre 2/Libre 3+ Continuous Glucose Monitor

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).

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.

Continuous glucose monitoring cohort (intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

type 2 diabetes with hemoglobin A1c ≥ 8%

You may qualify if:

• type 2 diabetes
• hemoglobin A1c ≥ 8%
• compatible smartphone with FreeStyle Libre 2 or Libre 3+ continuous glucose monitoring system
• current use and access to a glucometer for self-monitoring of blood glucose

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

USF Health Department of Family Medicine

Tampa, Florida, 33612, United States

RECRUITING

Related Publications (1)

• Cowart K, White RT, Olson K, Carris NW, Hanna K, Zgibor J. Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 May 23;14:e67014. doi: 10.2196/67014.

  PMID: 40409747 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kevin Cowart, PharmD, MPH

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Cowart, PharmD, MPH

CONTACT

813-974-5562; kcowart2@usf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)