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

NCT ID: NCT03290768

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-13
• Study Completion Date: 2018-06-01

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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Diabetes Management Educational Program

Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.

Group Type: EXPERIMENTAL

Continuous Glucose Monitor (CGM)

Intervention Type: DEVICE

Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

Activity Tracker

Intervention Type: DEVICE

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.

Coaching

Intervention Type: BEHAVIORAL

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.

Interventions

Continuous Glucose Monitor (CGM)

Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Dexcom Investigational Use Only (IUO) Device; Fitbit Charge 2

Eligibility Criteria

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Savvysherpa, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Southwest Medical Associates

Las Vegas, Nevada, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00022589

Identifier Type: -

Identifier Source: org_study_id