Pharmacist-driven CGM Use in the Uninsured Population

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: FreeStyle LibrePro CGM

• Registration Number: NCT03477838
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-26
• Study Start: 2018-04-26
• Primary Completion: 2019-12-19
• Study Completion: 2019-12-19
• Results First Submitted: 2020-12-18
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-19
• Results First Posted: 2021-02-05
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CGM Intervention arm	FreeStyle LibrePro CGM	Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use.

Primary Outcome Measures

Name	Time	Method
Change in A1c	Baseline to week 12	Change in A1c will be used to assess glycemic control

Secondary Outcome Measures

Name	Time	Method
Medication Changes	Baseline to week 12	Data will be collected on what medication changes are made (changes in types of medications and doses)
Glycemic Variability	Baseline to week 12	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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States