Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3)

Type2 Diabetes Clinical Trial

— CGM_IRB-3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290768
• Other study ID #: Pro00022589
• Status: Completed
• Phase: N/A
• Start date: September 13, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2018
• Source: Savvysherpa, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Be diagnosed with type 2 diabetes

• Be able to read and understand English

• Have access to a telephone

• Have a Medicare Advantage health plan through Senior Dimensions

Exclusion Criteria:

• Pregnant

• Blind

• Deaf

• Receiving chemotherapy or radiation to treat cancer (now or in past 6 months)

• Misusing 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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Device:
• Continuous Glucose Monitor (CGM)
Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.
• Activity Tracker
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.

Behavioral:
• Coaching
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.

Locations

Country	Name	City	State
United States	Southwest Medical Associates	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Savvysherpa, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Program Enrollment Rate (%)	(Number of patients who were shipped devices) / (Number of patients invited to enroll) * 100	up to 9 months
Primary	Program Completion Rate (%)	(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100	up to 9 months
Secondary	Weekly Average of Estimated Glucose Values (EGV)	(Sum of EGV for a given week) / (Total number of EGV for a given week)	up to 10 weeks
Secondary	Change in Medication Dosage (mg/Day; U/Day)	(dosage of Rx on Day 180) - (dosage of Rx on Day 0)	up to 9 months
Secondary	Average Age of Participants Who Start Trial (Yrs)	(Sum of ages of all enrollees) / (Total number of enrollees)	up to 9 months
Secondary	Average Age of Participants Who Complete Trial (Yrs)	(Sum of age of patients who complete) / (Total number who complete)	up to 9 months
Secondary	Texting With Coaches	(Sum of all text messages) / (Total number of participants*days)	up to 9 months
Secondary	Coaching Participation Rate	(Sum of weekly coaching calls completed) / (Total number of participants*weeks)	up to 9 months