Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics (CGM_IRB2)

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

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): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Rogelio Machuca, MD Family Medicine, PLLC

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
• 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

Exclusion Criteria:

• 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
  • 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: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in A1c Measurement (%)	(Final A1c measure)-(Initial A1c measure)	Day 0 and Day 180
Weekly Average of Estimated Glucose Values (EGV) (Average)	(Sum of EGV for one week)/(Total number of EGV)	up to six months
Change in Medication Dosage (mg/Day; U/Day)	(dosage of Rx on Day 180)-(dosage of Rx on Day 0)	up to six months
Average Age of Participants Who Start Trial (Yrs)	(Sum of ages of all enrollees)/(Total number of enrollees)	up to three months
Average Age of Participants Who Complete Trial (Yrs)	(Sum of age of patients who complete)/(Total number who complete)	up to six months
Race of Participants Who Start the Trial (n)	Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White	up to three months
Ethnicity of Participants Who Start the Trial (n)	Sum of Hispanic or Latino and Sum of Not Hispanic or Latino	up to three months
Texting With Coaches (Daily Average of Text Messages)	(Sum of all text messages)/(Total number of days)	up to six months
Coaching Participation Rate	(Sum of weekly coaching calls completed)/(Total number of weeks)	up to six months

Collaborators and Investigators

• Sponsor: Savvysherpa, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 28, 2017
• Primary Completion (ACTUAL): May 23, 2018
• Study Completion (ACTUAL): February 25, 2019

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (ACTUAL): August 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

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: Pro00021722

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