Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes

Study Overview
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Brief Summary
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The objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2 diabetes who are on non-insulin therapies.

Detailed Description
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The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system. This investigation is a 2-phase cross-over study with patients serving as their own controls. The demographics, medical history, anthropometric and laboratory data are collected at baseline for each patient. During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Anthropometric and laboratory data (including HB A1c) are collected. Medical providers are also un-blinded and adjust medical recommendations and interventions, in part based on CGM data, as appropriate. All patients will receive usual care which will include individual and virtual lifestyle education, virtual support group, M.D. visits, medication interventions, referrals to support programs outside the scope of CINEMA program and nursing support

Official Title
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Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for the Care of Patients With Type 2 Diabetes Not Using Insulin Therapy

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: Dexcom continuous glucose monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes of any duration Hb A1c ≥ 7% (no upper limit) BMI ≥ 30 kg/m2 Ability to wear CGM (e.g. no dermatological issue precluding device insertion) Access to a smartphone device Exclusion Criteria: Any insulin use in the past 3 months Planned use of insulin in the next 6 months Presence of a blood disorder (such as sickle cell anemia) making glycosylated hemoglobin measurement inaccurate Current use of a weight loss medication Unable or uncomfortable with wearing a CGM device

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Blinded<br>During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. | |
| Experimental: Unblinded<br>During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. | Device: Dexcom continuous glucose monitor<br>* The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average glucose levels as measured by continuous glucose monitor | Average glucose on CGM | 0, 30, 60, 90 days | 
| Change in time in range as measured by continuous glucose monitor | Time in range on CGM | 0, 30, 60, 90 days | 
| Change in glucose variability as measured by continuous glucose monitor | Glucose variability on CGM | 0, 30, 60, 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c from blood test | Glycosylated hemoglobin | 0 and 90 days | 
| Change in Total cholesterol from blood test | Total cholesterol | 0 and 90 days | 
| Change in Low density lipoprotein cholesterol from blood test | LDL-C | 0 and 90 days | 
| Change in High density lipoprotein cholesterol from blood test | HDL-C | 0 and 90 days | 
| Change in Triglycerides from blood test | Triglycerides | 0 and 90 days | 
| Change in Body mass index from height and weight | BMI | 0 and 90 days | 
| Change in Blood pressure from automated cuff | Systolic and diastolic blood pressure | 0 and 90 days | 
| Picture Your Plate dietary assessment questionnaire | Picture Your PlateTM is a brief (48-question) dietary assessment questionnaire | 90 days | 
| Type 2 Diabetes Distress Screening Scale (T2-DDAS) | The T2-DDAS is a self-report survey that has 29 items. | 90 days | 
| International Physical Activity Questionnaire (IPAQ) | The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity. | 90 days | 
| Glucose Monitoring Satisfaction Survey | The GMSS is a reliable, valid measure of glucose device satisfaction in its T1D form and in its insulin-using T2D form. It provides a comprehensive profile of sources of device satisfaction for use in clinical care and research. | 90 days |