NCT04413578

CGM - Reimagine Primary Care

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	Dexcom G6	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.
DEVICE	Contour NextOne	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.

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-11-28
• Completion: 2019-12-31
• First posted: 2020-06-04
• Last updated: 2020-06-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study