Pharmacist-driven CGM Use in the Uninsured Population
A Pharmacist-driven Continuous Glucose Monitoring Program for Advanced Diabetes Management in an Uninsured Population
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2018
CompletedFirst Posted
Study publicly available on registry
March 26, 2018
CompletedStudy Start
First participant enrolled
April 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2019
CompletedResults Posted
Study results publicly available
February 5, 2021
CompletedFebruary 5, 2021
January 1, 2021
1.6 years
March 19, 2018
December 18, 2020
January 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in A1c
Change in A1c will be used to assess glycemic control
Baseline to week 12
Secondary Outcomes (2)
Medication Changes
Baseline to week 12
Glycemic Variability
Baseline to week 12
Study Arms (1)
CGM Intervention arm
EXPERIMENTALPatients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use.
Interventions
a professional CGM device will be worn by the participant for up to 14 days
Eligibility Criteria
You may qualify if:
- adult 18 years of age or older
- diagnosis of Type 1 or Type 2 diabetes
- A1c greater than 8%
- prescribed basal insulin plus either prandial insulin or a glucagon-like peptide-1 (GLP-1) receptor agonist
You may not qualify if:
- pregnant or breast-feeding
- on dialysis
- not appropriate for CGM use based on clinical judgment by the investigators
- patients with limited English proficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Evan Sisson, PharmD
- Organization
- Virginia Commonwealth University
Study Officials
- PRINCIPAL INVESTIGATOR
Evan Sisson, PharmD
Virginia Commonwealth University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2018
First Posted
March 26, 2018
Study Start
April 26, 2018
Primary Completion
December 19, 2019
Study Completion
December 19, 2019
Last Updated
February 5, 2021
Results First Posted
February 5, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share