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Completed

NCT Number: NCT03290768

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

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.

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Key information

Conditions

Type2 Diabetes

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southwest Medical Associates

Las Vegas, Nevada, 89102, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Continuous Glucose Monitor (CGM)

Device

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

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.

Other names: Fitbit Charge 2

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.

Primary outcomes

  1. Program Enrollment Rate (%)

    Time frame: up to 9 months

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

  2. Program Completion Rate (%)

    Time frame: up to 9 months

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

Secondary outcomes

  1. Weekly Average of Estimated Glucose Values (EGV)

    Time frame: up to 10 weeks

    (Sum of EGV for a given week) / (Total number of EGV for a given week)

  2. Change in Medication Dosage (mg/Day; U/Day)

    Time frame: up to 9 months

    (dosage of Rx on Day 180) - (dosage of Rx on Day 0)

  3. Average Age of Participants Who Start Trial (Yrs)

    Time frame: up to 9 months

    (Sum of ages of all enrollees) / (Total number of enrollees)

  4. Average Age of Participants Who Complete Trial (Yrs)

    Time frame: up to 9 months

    (Sum of age of patients who complete) / (Total number who complete)

  5. Texting With Coaches

    Time frame: up to 9 months

    (Sum of all text messages) / (Total number of participants*days)

  6. Coaching Participation Rate

    Time frame: up to 9 months

    (Sum of weekly coaching calls completed) / (Total number of participants*weeks)

Sponsors and collaborators

Lead sponsor

Savvysherpa, Inc.

Industry

Registry information

Official study title

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

Acronym: CGM_IRB-3

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2017
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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