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

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

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Device: Continuous Glucose Monitor (CGM); Device: Activity Tracker; Behavioral: Coaching

• Study Type: Interventional
• Enrollment (Actual): 358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Southwest Medical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diabetes Management Educational Program; Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.

Device: Continuous Glucose Monitor (CGM); Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.; Other Names: Dexcom Investigational Use Only (IUO) Device; 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.; Other Names: Fitbit Charge 2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in Medication Dosage (mg/Day; U/Day)	(dosage of Rx on Day 180) - (dosage of Rx on Day 0)	up to 9 months
Average Age of Participants Who Start Trial (Yrs)	(Sum of ages of all enrollees) / (Total number of enrollees)	up to 9 months
Average Age of Participants Who Complete Trial (Yrs)	(Sum of age of patients who complete) / (Total number who complete)	up to 9 months
Texting With Coaches	(Sum of all text messages) / (Total number of participants*days)	up to 9 months
Coaching Participation Rate	(Sum of weekly coaching calls completed) / (Total number of participants*weeks)	up to 9 months

Collaborators and Investigators

• Sponsor: Savvysherpa, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Pro00022589

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No