CGM - Reimagine Primary Care

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Dexcom G6
* Device: Contour NextOne


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Randomized Control Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexcom G6 (Intervention Group)<br>• 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 | Device: Dexcom G6<br>* 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.<br>|
| Placebo Comparator: Contour NextOne (Standard of Care) Glucometer<br>• 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. | Device: Contour NextOne<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c Variation | Coefficient of variation in HbA1c levels before, during and end of study completion. | 6 months | 
| HbA1c Range | 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 | Current HEDIS performance on diabetes and behavioral health measures. | 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). | 6 months | 
| Hypoglycemic Events | Frequency of hypoglycemic events during the study. | 6 months | 
| Healthcare Utilization | Healthcare utilization per count of inpatient/outpatient visits. | 6 months | 
| Glycemic Variability | Glycemic variability per mean amplitude of glycemic excursion (MAGE) | 6 months | 
| Emergency Room Visits | Emergency department visits per 1000 rate, overall and for patients with diabetes, and hospitalization per 1000 rate related to. | 6 months | 
| Healthcare Cost | Cost per patient of healthcare for Emergency Room visits, blood draws, inpatient/outpatient services, medications etc. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Glucose Monitor (CGM), Dexcom G6