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OpenTrials
Completed

NCT Number: NCT03477838

Pharmacist-driven CGM Use in the 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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • pregnant or breast-feeding
  • on dialysis
  • not appropriate for CGM use based on clinical judgment by the investigators
  • patients with limited English proficiency

Treatment and study plan

FreeStyle LibrePro CGM

Device

a professional CGM device will be worn by the participant for up to 14 days

Primary outcomes

  1. Change in A1c

    Time frame: Baseline to week 12

    Change in A1c will be used to assess glycemic control

Secondary outcomes

  1. Medication Changes

    Time frame: Baseline to week 12

    Data will be collected on what medication changes are made (changes in types of medications and doses)

  2. Glycemic Variability

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2018
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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