Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics

Study Overview
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Brief Summary
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This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor (CGM) as part of an educational program designed to help them better manage their glucose levels. Subjects will also wear an activity tracker to monitor their activity and observe its effect on their glucose levels. The educational program will involve calls from coaches to check subjects' progress and answer questions.

Official Title
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Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Device: Continuous Glucose Monitor (CGM)
* Device: Activity Tracker
* Behavioral: Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be diagnosed with type 2 diabetes Currently take a DPP4 inhibitor, SGLT2 inhibitor, GLP-1 agonist, and/or basal insulin Be able to read and understand English Have access to a telephone Have a Medicare health plan Exclusion Criteria: Pregnant Blind Deaf Currently receiving chemotherapy or radiation therapy to treat cancer Addicted to any drugs (including alcohol, painkillers, hallucinogens, or others) Critically ill Diagnosed with or experiencing: Kidney disease stages 4 and 5 End stage renal disease Severe liver disease Dementia Schizophrenia Bipolar disorder Autism An intellectual or learning disability Arrhythmias other than atrial fibrillation Congestive heart failure Has had a: Myocardial infarction within the last 6 months Stroke within the last 6 months Stroke that resulted in significant disability (e.g., unable to write clearly or walk)

Ages Eligible for Study
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Minimum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Management Educational Program<br>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels. | Device: Continuous Glucose Monitor (CGM)<br>* Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.<br>* Other names: Dexcom Investigational Use Only (IUO) Device;Device: Activity Tracker<br>* Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.<br>* Other names: Fitbit Charge 2;Behavioral: Coaching<br>* Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program Enrollment Rate (%) | (Number of patients who signed a consent form)/(Number of patients invited to enroll) | up to three months | 
| Program Completion Rate (%) | (Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form) | up to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1c Measurement (%) | (Final A1c measure)-(Initial A1c measure) | Day 0 and Day 180 | 
| Weekly Average of Estimated Glucose Values (EGV) (Average) | (Sum of EGV for one week)/(Total number of EGV) | up to six months | 
| Change in Medication Dosage (mg/Day; U/Day) | (dosage of Rx on Day 180)-(dosage of Rx on Day 0) | up to six months | 
| Average Age of Participants Who Start Trial (Yrs) | (Sum of ages of all enrollees)/(Total number of enrollees) | up to three months | 
| Average Age of Participants Who Complete Trial (Yrs) | (Sum of age of patients who complete)/(Total number who complete) | up to six months | 
| Race of Participants Who Start the Trial (n) | Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White | up to three months | 
| Ethnicity of Participants Who Start the Trial (n) | Sum of Hispanic or Latino and Sum of Not Hispanic or Latino | up to three months | 
| Texting With Coaches (Daily Average of Text Messages) | (Sum of all text messages)/(Total number of days) | up to six months | 
| Coaching Participation Rate | (Sum of weekly coaching calls completed)/(Total number of weeks) | up to six months |