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

NCT03290768 | Completed Results FDA Device

• 1 other identifier: Pro00022589
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Program Enrollment Rate (%)

  (Number of patients who were shipped devices) / (Number of patients invited to enroll) \* 100

  up to 9 months

• Program Completion Rate (%)

  (Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) \* 100

  up to 9 months

Secondary Outcomes (6)

• Weekly Average of Estimated Glucose Values (EGV)

  up to 10 weeks

• Change in Medication Dosage (mg/Day; U/Day)

  up to 9 months

• Average Age of Participants Who Start Trial (Yrs)

  up to 9 months

• Average Age of Participants Who Complete Trial (Yrs)

  up to 9 months

• Texting With Coaches

  up to 9 months

Study Arms (1)

Diabetes Management Educational Program

EXPERIMENTAL

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

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

Interventions

Continuous Glucose Monitor (CGM) DEVICE

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

Also known as: Dexcom Investigational Use Only (IUO) Device

Diabetes Management Educational Program

Activity Tracker 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.

Also known as: Fitbit Charge 2

Diabetes Management Educational Program

Coaching 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.

Diabetes Management Educational Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Savvysherpa, Inc.: lead

Study Sites (1)

Southwest Medical Associates

Las Vegas, Nevada, 89102, United States

Location

MeSH Terms

Interventions

Fitness Trackers

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Results Point of Contact

• Title: Jared Jones
• Organization: Savvysherpa, LLC

JaredJones@savvysherpa.com

763-549-3540

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: September 13, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 18, 2021
• Results First Posted: July 16, 2019

Record last verified: 2018-06

Locations

US (1)