Pharmacist-driven CGM Use in the Uninsured Population

NCT ID: NCT03477838

Last Updated: 2021-02-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-26

Study Completion Date

2019-12-19

Brief Summary

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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

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

FreeStyle LibrePro CGM

Intervention Type DEVICE

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

Interventions

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FreeStyle LibrePro CGM

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evan Sisson, PharmD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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HM20012049

Identifier Type: -

Identifier Source: org_study_id

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