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

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ClinicalTrials.gov Identifier: NCT03290768
Recruitment Status : Active, not recruiting
First Posted : September 25, 2017
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Savvysherpa, Inc.

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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Device: Continuous Glucose Monitor (CGM) Device: Activity Tracker Behavioral: Coaching Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot (SMA Investigational Device)
Actual Study Start Date : September 13, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

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 Name: 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 Name: 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.



Primary Outcome Measures :
  1. Program Enrollment Rate (%) [ Time Frame: up to three months ]
    (Number of patients who were shipped devices) / (Number of patients invited to enroll)

  2. Program Completion Rate (%) [ Time Frame: up to 11 months ]
    (Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices)


Secondary Outcome Measures :
  1. Weekly Average of Estimated Glucose Values (EGV) (Average) [ Time Frame: up to 10 weeks ]
    (Sum of EGV for one week) / (Total number of EGV)

  2. Change in Medication Dosage (mg/day; U/day) [ Time Frame: up to 11 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 three months ]
    (Sum of ages of all enrollees) / (Total number of enrollees)

  4. Average Age of Participants Who Complete Trial (yrs) [ Time Frame: up to 11 months ]
    (Sum of age of patients who complete) / (Total number who complete)

  5. Texting with Coaches [ Time Frame: up to 10 weeks ]
    (Sum of all text messages) / (Total number of days)

  6. Coaching Participation Rate [ Time Frame: up to 10 weeks ]
    (Sum of weekly coaching calls completed) / (Total number of weeks)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290768


Locations
United States, Nevada
Southwest Medical Associates
Las Vegas, Nevada, United States, 89102
Sponsors and Collaborators
Savvysherpa, Inc.
  Study Documents (Full-Text)

Documents provided by Savvysherpa, Inc.:

Responsible Party: Savvysherpa, Inc.
ClinicalTrials.gov Identifier: NCT03290768     History of Changes
Other Study ID Numbers: Pro00022589
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases