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

Primary Purpose

Type2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitor (CGM)
Activity Tracker
Coaching
Sponsored by
Savvysherpa, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type2 Diabetes

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Rogelio Machuca, MD Family Medicine, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diabetes Management Educational Program

Arm Description

Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.

Outcomes

Primary Outcome Measures

Program Enrollment Rate (%)
(Number of patients who signed a consent form)/(Number of patients invited to enroll)
Program Completion Rate (%)
(Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)

Secondary Outcome Measures

Change in A1c Measurement (%)
(Final A1c measure)-(Initial A1c measure)
Weekly Average of Estimated Glucose Values (EGV) (Average)
(Sum of EGV for one week)/(Total number of EGV)
Change in Medication Dosage (mg/Day; U/Day)
(dosage of Rx on Day 180)-(dosage of Rx on Day 0)
Average Age of Participants Who Start Trial (Yrs)
(Sum of ages of all enrollees)/(Total number of enrollees)
Average Age of Participants Who Complete Trial (Yrs)
(Sum of age of patients who complete)/(Total number who complete)
Race of Participants Who Start the Trial (n)
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
Ethnicity of Participants Who Start the Trial (n)
Sum of Hispanic or Latino and Sum of Not Hispanic or Latino
Texting With Coaches (Daily Average of Text Messages)
(Sum of all text messages)/(Total number of days)
Coaching Participation Rate
(Sum of weekly coaching calls completed)/(Total number of weeks)

Full Information

First Posted
August 9, 2017
Last Updated
May 22, 2019
Sponsor
Savvysherpa, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03252964
Brief Title
Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics
Acronym
CGM_IRB2
Official Title
Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
February 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Savvysherpa, Inc.

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetes Management Educational Program
Arm Type
Experimental
Arm Description
Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitor (CGM)
Other Intervention Name(s)
Dexcom Investigational Use Only (IUO) Device
Intervention Description
Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.
Intervention Type
Device
Intervention Name(s)
Activity Tracker
Other Intervention Name(s)
Fitbit Charge 2
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coaching
Intervention Description
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 Measure Information:
Title
Program Enrollment Rate (%)
Description
(Number of patients who signed a consent form)/(Number of patients invited to enroll)
Time Frame
up to three months
Title
Program Completion Rate (%)
Description
(Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)
Time Frame
up to six months
Secondary Outcome Measure Information:
Title
Change in A1c Measurement (%)
Description
(Final A1c measure)-(Initial A1c measure)
Time Frame
Day 0 and Day 180
Title
Weekly Average of Estimated Glucose Values (EGV) (Average)
Description
(Sum of EGV for one week)/(Total number of EGV)
Time Frame
up to six months
Title
Change in Medication Dosage (mg/Day; U/Day)
Description
(dosage of Rx on Day 180)-(dosage of Rx on Day 0)
Time Frame
up to six months
Title
Average Age of Participants Who Start Trial (Yrs)
Description
(Sum of ages of all enrollees)/(Total number of enrollees)
Time Frame
up to three months
Title
Average Age of Participants Who Complete Trial (Yrs)
Description
(Sum of age of patients who complete)/(Total number who complete)
Time Frame
up to six months
Title
Race of Participants Who Start the Trial (n)
Description
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
Time Frame
up to three months
Title
Ethnicity of Participants Who Start the Trial (n)
Description
Sum of Hispanic or Latino and Sum of Not Hispanic or Latino
Time Frame
up to three months
Title
Texting With Coaches (Daily Average of Text Messages)
Description
(Sum of all text messages)/(Total number of days)
Time Frame
up to six months
Title
Coaching Participation Rate
Description
(Sum of weekly coaching calls completed)/(Total number of weeks)
Time Frame
up to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Rogelio Machuca, MD Family Medicine, PLLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States

12. IPD Sharing Statement

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Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics

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