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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03290768
Recruitment Status : Active, not recruiting
First Posted : September 25, 2017
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Savvysherpa, Inc.

Tracking Information
First Submitted Date  ICMJE September 19, 2017
First Posted Date  ICMJE September 25, 2017
Results First Submitted Date  ICMJE May 23, 2019
Results First Posted Date  ICMJE July 16, 2019
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE September 13, 2017
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Program Enrollment Rate (%) [ Time Frame: up to 9 months ]
    (Number of patients who were shipped devices) / (Number of patients invited to enroll) * 100
  • Program Completion Rate (%) [ Time Frame: up to 11 months ]
    (Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
  • Program Enrollment Rate (%) [ Time Frame: up to three months ]
    (Number of patients who were shipped devices) / (Number of patients invited to enroll)
  • Program Completion Rate (%) [ Time Frame: up to 11 months ]
    (Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • 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)
  • 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)
  • Average Age of Participants Who Start Trial (Yrs) [ Time Frame: up to 9 months ]
    (Sum of ages of all enrollees) / (Total number of enrollees)
  • 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)
  • Texting With Coaches [ Time Frame: up to 11 months ]
    (Sum of all text messages) / (Total number of participants*days)
  • Coaching Participation Rate [ Time Frame: up to 11 months ]
    (Sum of weekly coaching calls completed) / (Total number of participants*weeks)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
  • Weekly Average of Estimated Glucose Values (EGV) (Average) [ Time Frame: up to 10 weeks ]
    (Sum of EGV for one week) / (Total number of EGV)
  • 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)
  • Average Age of Participants Who Start Trial (Yrs) [ Time Frame: up to three months ]
    (Sum of ages of all enrollees) / (Total number of enrollees)
  • 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)
  • Texting With Coaches [ Time Frame: up to 10 weeks ]
    (Sum of all text messages) / (Total number of days)
  • Coaching Participation Rate [ Time Frame: up to 10 weeks ]
    (Sum of weekly coaching calls completed) / (Total number of weeks)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3)
Official Title  ICMJE Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot (SMA Investigational Device)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Type2 Diabetes
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Diabetes Management Educational Program
Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.
Interventions:
  • Device: Continuous Glucose Monitor (CGM)
  • Device: Activity Tracker
  • Behavioral: Coaching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 25, 2019)
358
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2017)
500
Estimated Study Completion Date  ICMJE December 2027
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03290768
Other Study ID Numbers  ICMJE Pro00022589
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Savvysherpa, Inc.
Study Sponsor  ICMJE Savvysherpa, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Savvysherpa, Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP