CGM - Reimagine Primary Care

Intermountain Health Care, Inc.101 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Diabetes Mellitus, Type 2

Interventions

Dexcom G6DEVICE

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.

Contour NextOneDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Holladay Internal Medicine

Holladay, Utah, United States

Intermountain Cottonwood Family Practice

Murray, Utah, United States

Intermountain Senior Clinic

Murray, Utah, United States

Avenues Internal Medicine

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

HbA1c Variation

Coefficient of variation in HbA1c levels before, during and end of study completion.

Time frame: 6 months

HbA1c Range

Variation of range in HbA1c levels before, during and end of study completion.

Time frame: 6 months

Secondary Outcomes

Current Diabetes Standards

Current HEDIS performance on diabetes and behavioral health measures.

Time frame: 6 months

Behavioral Changes

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).

Time frame: 6 months

Hypoglycemic Events

Frequency of hypoglycemic events during the study.

Time frame: 6 months

Healthcare Utilization

Healthcare utilization per count of inpatient/outpatient visits.

Time frame: 6 months

Glycemic Variability

Glycemic variability per mean amplitude of glycemic excursion (MAGE)

Time frame: 6 months

Emergency Room Visits

Emergency department visits per 1000 rate, overall and for patients with diabetes, and hospitalization per 1000 rate related to.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.