NCT03252964

Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Savvysherpa, Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitor (CGM)	Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.
DEVICE	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.

Timeline

• Start date: 2017-07-28
• Primary completion: 2018-05-23
• Completion: 2019-02-25
• First posted: 2017-08-17
• Last updated: 2019-05-24
• Results posted: 2019-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study