Pharmacist-driven CGM Use in the Uninsured Population

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477838
• Other study ID #: HM20012049
• Status: Completed
• Phase: N/A
• Start date: April 26, 2018
• Est. completion date: December 19, 2019

Study information

• Verified date: January 2021
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 19, 2019
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• FreeStyle LibrePro CGM
a professional CGM device will be worn by the participant for up to 14 days

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in A1c	Change in A1c will be used to assess glycemic control	Baseline to week 12
Secondary	Medication Changes	Data will be collected on what medication changes are made (changes in types of medications and doses)	Baseline to week 12
Secondary	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