Pharmacist-led Continuous Glucose Monitoring

Official title

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

Overview

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)

Interventions

• 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.

Primary outcome measures

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

Secondary outcome measures (12)

• Time in Range [Time frame: Baseline to End of Study (12 weeks)]
• Mean Sensor Glucose [Time frame: Baseline to End of Study (12 weeks)]
• Time Below Range [Time frame: Baseline to End of Study (12 weeks)]
• Time Above Range [Time frame: Baseline to End of Study (12 weeks)]
• Glycemic Variability [Time frame: Baseline to End of Study (12 weeks)]
• Time in Range Increase 5% [Time frame: Baseline to End of Study (12 weeks)]
• Time in Range Increase 10% [Time frame: Baseline to End of Study (12 weeks)]
• >70% Time in Range [Time frame: Baseline to End of Study (12 weeks)]
• Hemoglobin A1c <7% [Time frame: Baseline to End of Study (12 weeks)]
• Hemoglobin A1c <8% [Time frame: Baseline to End of Study (12 weeks)]
• Summary of Diabetes Self-Care Activities Measure [Time frame: Baseline to End of Study (12 weeks)]
• Continuous Glucose Monitoring Survey Responses [Time frame: Baseline to End of Study (12 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• USF Health Department of Family Medicine — Tampa

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. PMID 40409747

Identifiers

NCT: NCT06572306 · STUDY007451

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗