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Completed

NCT Number: NCT03252964

Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics

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

Rogelio Machuca, MD Family Medicine, PLLC

Las Vegas, Nevada, 89104, 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
  • 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)

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 three months

    (Number of patients who signed a consent form)/(Number of patients invited to enroll)

  2. Program Completion Rate (%)

    Time frame: up to six months

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

Secondary outcomes

  1. Change in A1c Measurement (%)

    Time frame: Day 0 and Day 180

    (Final A1c measure)-(Initial A1c measure)

  2. Weekly Average of Estimated Glucose Values (EGV) (Average)

    Time frame: up to six months

    (Sum of EGV for one week)/(Total number of EGV)

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

    Time frame: up to six months

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

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

    Time frame: up to three months

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

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

    Time frame: up to six months

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

  6. Race of Participants Who Start the Trial (n)

    Time frame: up to three months

    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

  7. Ethnicity of Participants Who Start the Trial (n)

    Time frame: up to three months

    Sum of Hispanic or Latino and Sum of Not Hispanic or Latino

  8. Texting With Coaches (Daily Average of Text Messages)

    Time frame: up to six months

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

  9. Coaching Participation Rate

    Time frame: up to six months

    (Sum of weekly coaching calls completed)/(Total number of 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

Acronym: CGM_IRB2

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 17, 2017
Registry last updated
May 24, 2019

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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