Pharmacist-led Continuous Glucose Monitoring

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

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)

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: FreeStyle Libre 2/Libre 3+ Continuous Glucose Monitor

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Kevin Cowart, PharmD, MPH; Phone Number: 813-974-5562; Email: kcowart2@usf.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • USF Health Department of Family Medicine
      • Contact: Kevin Cowart, PharmD, MPH; Phone Number: 813-974-5562; Email: kcowart2@usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

type 2 diabetes with hemoglobin A1c ≥ 8%

Description

Inclusion Criteria:

• 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

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Sensor Glucose	Change in mean sensor glucose concentration at 12 weeks, mg/dL, compared within the intervention cohort	Baseline to End of Study (12 weeks)
Time in Range	Change in the time in range (70-180 mg/dL) at 12 weeks, %, compared within the intervention cohort	Baseline to End of Study (12 weeks)
Time Below Range	Change in time below range (< 54mg/dL and < 70 mg/dL) at 12 weeks, %, compared within the intervention cohort	Baseline to End of Study (12 weeks)
Time Above Range	Change in time above range (> 180 mg/dL and > 250 mg/dL) at 12 weeks, %, compared within the intervention cohort	Baseline to End of Study (12 weeks)
Glycemic Variability	Change in glycemic variability (standard deviation, and Coefficient of variance) at 12 weeks, compared within the intervention cohort	Baseline to End of Study (12 weeks)
Time in Range Increase 5%	Change in the number of subjects increasing 5% or more in time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort	Baseline to End of Study (12 weeks)
Time in Range Increase 10%	Change in the number of subjects increasing 10% or more in time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort	Baseline to End of Study (12 weeks)
>70% Time in Range	Change in the number of subjects achieving > 70% time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort	Baseline to End of Study (12 weeks)
Hemoglobin A1c <7%	Change in the number of subjects achieving hemoglobin A1c < 7% at 12 weeks compared between intervention and historical cohort	Baseline to End of Study (12 weeks)
Hemoglobin A1c <8%	Change in the number of subjects achieving hemoglobin A1c < 8% at 12 weeks compared between intervention and historical cohort	Baseline to End of Study (12 weeks)
Summary of Diabetes Self-Care Activities Measure	Change in the Summary of Diabetes Self-Care Activities Measure at 12 weeks, compared within the intervention group. Scored on an 8-point likert scale (0-7). Higher scores indicate better compliance with diabetes self-care, whereas a lower score indicate poor self-care performance.	Baseline to End of Study (12 weeks)
Continuous Glucose Monitoring Survey Responses	Change in survey responses at 12 weeks, compared within the intervention group	Baseline to End of Study (12 weeks)

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Kevin Cowart, PharmD, MPH, University of South Florida

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: type 2 diabetes; pharmacist; continuous glucose monitor; endocrine disorders
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Endocrine System Diseases
• Other Study ID Numbers: STUDY007451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes