CGM - Reimagine Primary Care

Intermountain Health Care, Inc.

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Dexcom G6; Device: Contour NextOne

Study type: Interventional

Funder types: Other

Identifiers

NCT04413578

1050955

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups, including a placebo group

Dexcom G6 (Intervention Group)

Experimental group

Description:

• 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

Treatment:

Device: Dexcom G6

Contour NextOne (Standard of Care) Glucometer

Placebo Comparator group

Description:

• 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.

Treatment:

Device: Contour NextOne