Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics

NCT03252964 | Completed Results FDA Device

• 1 other identifier: Pro00021722
• Study Type: interventional
• Target: 52
• 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 signed a consent form)/(Number of patients invited to enroll)

  up to three months

• Program Completion Rate (%)

  (Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)

  up to six months

Secondary Outcomes (9)

• Change in A1c Measurement (%)

  Day 0 and Day 180

• Weekly Average of Estimated Glucose Values (EGV) (Average)

  up to six months

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

  up to six months

• Average Age of Participants Who Start Trial (Yrs)

  up to three months

• Average Age of Participants Who Complete Trial (Yrs)

  up to six 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Savvysherpa, Inc.: lead

Study Sites (1)

Rogelio Machuca, MD Family Medicine, PLLC

Las Vegas, Nevada, 89104, 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, PhD
• Organization: Savvysherpa, Inc.

JaredJones@savvysherpa.com

7635493540

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: August 9, 2017
• First Posted: August 17, 2017
• Study Start: July 28, 2017
• Primary Completion: May 23, 2018
• Study Completion: February 25, 2019
• Last Updated: May 24, 2019
• Results First Posted: May 1, 2019

Record last verified: 2019-05

Locations

US (1)