Back to resultsContinuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3) (CGM_IRB-3)
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
About this trial
This is an interventional supportive care trial for Type2 Diabetes
Eligibility 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)
Sites / Locations
- Southwest Medical Associates
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 were shipped devices) / (Number of patients invited to enroll) * 100
Program Completion Rate (%)
(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100
Secondary Outcome Measures
Weekly Average of Estimated Glucose Values (EGV)
(Sum of EGV for a given week) / (Total number of EGV for a given week)
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)
Texting With Coaches
(Sum of all text messages) / (Total number of participants*days)
Coaching Participation Rate
(Sum of weekly coaching calls completed) / (Total number of participants*weeks)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03290768
Brief Title
Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3)
Acronym
CGM_IRB-3
Official Title
Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot (SMA Investigational Device)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 13, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (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
358 (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 were shipped devices) / (Number of patients invited to enroll) * 100
Time Frame
up to 9 months
Title
Program Completion Rate (%)
Description
(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100
Time Frame
up to 9 months
Secondary Outcome Measure Information:
Title
Weekly Average of Estimated Glucose Values (EGV)
Description
(Sum of EGV for a given week) / (Total number of EGV for a given week)
Time Frame
up to 10 weeks
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 9 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 9 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 9 months
Title
Texting With Coaches
Description
(Sum of all text messages) / (Total number of participants*days)
Time Frame
up to 9 months
Title
Coaching Participation Rate
Description
(Sum of weekly coaching calls completed) / (Total number of participants*weeks)
Time Frame
up to 9 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
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)
Facility Information:
Facility Name
Southwest Medical Associates
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3)
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