Pharmacist-driven CGM Use in the Uninsured Population

A Pharmacist-driven Continuous Glucose Monitoring Program for Advanced Diabetes Management in an Uninsured Population

This is a pilot study. The purpose is to (1) provide access to continuous glucose monitoring (CGM) to patients (purchased through a grant) and (2) systematically record and analyze the results of the glucose monitoring by the clinical pharmacists at the clinic.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: FreeStyle LibrePro CGM

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. adult 18 years of age or older
2. diagnosis of Type 1 or Type 2 diabetes
3. A1c greater than 8%
4. prescribed basal insulin plus either prandial insulin or a glucagon-like peptide-1 (GLP-1) receptor agonist

Exclusion Criteria:

1. pregnant or breast-feeding
2. on dialysis
3. not appropriate for CGM use based on clinical judgment by the investigators
4. patients with limited English proficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM Intervention arm; Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use.	Device: FreeStyle LibrePro CGM; a professional CGM device will be worn by the participant for up to 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in A1c	Change in A1c will be used to assess glycemic control	Baseline to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Changes	Data will be collected on what medication changes are made (changes in types of medications and doses)	Baseline to week 12
Glycemic Variability	Data collected by the CGM, such as time-in-therapeutic range, will be evaluated to assess glycemic variability during the 14 day period of wearing the CGM	Baseline to week 12

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Evan Sisson, PharmD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2018
• Primary Completion (Actual): December 19, 2019
• Study Completion (Actual): December 19, 2019

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: continuous glucose monitoring
• Other Study ID Numbers: HM20012049

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