CGM - Reimagine Primary Care

May 28, 2020 updated by: Intermountain Health Care, Inc.

Assessing the Feasibility of Continuous Glucose Monitoring in Reimagine Primary Care Clinics

To assess the impact of continuous glucose monitoring versus standard of care (e.g. a finger-prick protocol using a glucometer) on clinical outcomes, healthcare utilization, and cost in patients with type I or II diabetes treated within the Reimagine Primary Care clinics.

Study Overview

Status

Completed

Detailed Description

This is a parallel randomized controlled trial. Eligible patients who consent will be randomized to one of two groups: (1) the intervention group who will be given a Dexcom G6 for CGM, or (2) the control group who will follow their current standard finger-prick protocol via a provided Contour Next ONE glucometer. The CGM group must download the Dexcom G6 and Clarity mobile apps for data capture, whereas the standard of care group will use the Contour Next mobile app for their respective readings.

The Dexcom G6 captures real-time, dynamic glucose data every five minutes. Devices used in this study are FDA approved and commercially available.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Utah
      • Holladay, Utah, United States, 84121
        • Holladay Internal Medicine
      • Murray, Utah, United States, 84107
        • Intermountain Cottonwood Family Practice
      • Murray, Utah, United States, 84107
        • Intermountain Senior Clinic
      • Salt Lake City, Utah, United States, 84103
        • Avenues Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus with a HbA1c ≥6.5%
  • Patients that are currently managing their glucose levels for diabetes with a glucose meter (or will be prescribed one by their healthcare provider)
  • Patients that are treated within the four Reimagine Primary Care clinics (Cottonwood Family Medicine, Cottonwood Senior, Avenues Internal Medicine, and Holladay Internal Medicine). • Patients 18-80 years of age

Exclusion Criteria:

  • Patients that are not managing their glucose levels for diabetes (and not advised to use a glucose monitor by their physician)
  • Patients that are not treated within the four Reimagine Primary Care clinics
  • Patients less than 18 years of age, and 81 years of age and older
  • Patients with a diagnosis of dementia
  • If the patient is currently using a Continuous Glucose Monitor
  • Patients with previous hospitalization for hypoglycemia within the last 18 months
  • No access to a mobile phone to download the Dexcom or Contour Next applications
  • Patients who are pregnant or planning to become pregnant over the course of their six-month participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexcom G6 (Intervention Group)
• Intervention group: CGM using a Dexcom G6 to measure glycosylated hemoglobin levels every five minutes. Patients will be asked to download the Dexcom G6 and Clarity applications (to have access to their real-time data) and be given a link to complete an exit survey in REDCap near the end of their study participation. Data will be sent via Bluetooth and then exported by the Intermountain research team into a Tableau (or similar) dashboard for data analysis/comparison
Continuous Glucose Monitor that, after applied, sends continuous glucose readings to to the patient's smartphone every 5 minutes. This allows the patients to receive more readings over a 24 hour period versus standard of care glucometer finger sticks.
Placebo Comparator: Contour NextOne (Standard of Care) Glucometer
• Control group: A standard finger-prick protocol that will require patients to continue with their daily fingerprick regimen established by their physician. This group will be given a Contour Next One meter to ensure that each patient is receiving the same level of accuracy by the same device. A review by Ekhlaspour et al of 17 glucose meters demonstrated wide variability, with only two devices achieving the 2013 ISO standard (with the most accurate being the Contour Next). Patients in the control group will be asked to download the Contour Next application which will send data via Bluetooth similar to above. Data will be aggregated, and protected health information removed prior to analysis (by Intermountain Healthcare and Savvysherpa). At the end of the study, patients will be asked to complete a short survey in REDCap about their willingness to participate in future studies.
A Standard of Care Glucometer with Bluetooth capability. The patient inserts a test strip into the device, takes a finger stick and collects a small blood sample on the tip of the strip to initiate the device to detect a glucose reading.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Variation
Time Frame: 6 months
Coefficient of variation in HbA1c levels before, during and end of study completion.
6 months
HbA1c Range
Time Frame: 6 months
Variation of range in HbA1c levels before, during and end of study completion.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Current Diabetes Standards
Time Frame: 6 months
Current HEDIS performance on diabetes and behavioral health measures.
6 months
Behavioral Changes
Time Frame: 6 months
Subjects will complete a self reported survey related to behavioral changes at end of study to assess self empowered behavioral changes after using the devices (e.g. feeling more empowered to self-manage care, engaged with changing healthcare behaviors, and patient perceptions of the technology).
6 months
Hypoglycemic Events
Time Frame: 6 months
Frequency of hypoglycemic events during the study.
6 months
Healthcare Utilization
Time Frame: 6 months
Healthcare utilization per count of inpatient/outpatient visits.
6 months
Glycemic Variability
Time Frame: 6 months
Glycemic variability per mean amplitude of glycemic excursion (MAGE)
6 months
Emergency Room Visits
Time Frame: 6 months
Emergency department visits per 1000 rate, overall and for patients with diabetes, and hospitalization per 1000 rate related to.
6 months
Healthcare Cost
Time Frame: 6 months
Cost per patient of healthcare for Emergency Room visits, blood draws, inpatient/outpatient services, medications etc.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

November 28, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Dexcom G6

3
Subscribe