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

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: NCT03252964
Recruitment Status : Completed
First Posted : August 17, 2017
Results First Posted : May 1, 2019
Last Update Posted : May 24, 2019
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
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
Actual Study Start Date : July 28, 2017
Actual Primary Completion Date : May 23, 2018
Actual Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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 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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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)

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): NCT03252964


Locations
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United States, Nevada
Rogelio Machuca, MD Family Medicine, PLLC
Las Vegas, Nevada, United States, 89104
Sponsors and Collaborators
Savvysherpa, Inc.
  Study Documents (Full-Text)

Documents provided by Savvysherpa, Inc.:
Study Protocol  [PDF] October 23, 2017
Informed Consent Form  [PDF] August 18, 2017
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: Savvysherpa, Inc.
ClinicalTrials.gov Identifier: NCT03252964    
Other Study ID Numbers: Pro00021722
First Posted: August 17, 2017    Key Record Dates
Results First Posted: May 1, 2019
Last Update Posted: May 24, 2019
Last Verified: May 2019

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