Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics

Not Applicable

Completed

Interventions: Device: Continuous Glucose Monitor (CGM)
Device: Activity Tracker
Behavioral: Coaching

Brief Summary: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Diabetes Management Educational Program	Activity Tracker	Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.
Diabetes Management Educational Program	Continuous Glucose Monitor (CGM)	Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.
Diabetes Management Educational Program	Coaching	Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.

Primary Outcome Measures

Name	Time	Method
Program Completion Rate (%)	up to six months	(Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)
Program Enrollment Rate (%)	up to three months	(Number of patients who signed a consent form)/(Number of patients invited to enroll)

Secondary Outcome Measures

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