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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.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Type2 Diabetes
Interventions Device: Continuous Glucose Monitor (CGM)
Device: Activity Tracker
Behavioral: Coaching
Enrollment 52
Recruitment Details 364 candidates were contacted. Of those, 52 enrolled.
Pre-assignment Details  
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Period Title: Overall Study
Started 52
Completed 20
Not Completed 32
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
<=18 years
0
   0.0%
Between 18 and 65 years
44
  84.6%
>=65 years
8
  15.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
26
  50.0%
Male
26
  50.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Program Enrollment Rate (%)
Hide Description (Number of patients who signed a consent form)/(Number of patients invited to enroll)
Time Frame up to three months
Hide Outcome Measure Data
Hide Analysis Population Description
52 participants enrolled in the study. Hence, 52 participants analyzed. However, enrollment rate is the number of participants enrolled (52) divided by the number of candidates contacted (364). This explains why the Overall Number of Participants Analyzed is greater than the number Started in the Participant Flow.
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description:

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Overall Number of Participants Analyzed 364
Measure Type: Number
Unit of Measure: Percentage of participants
14
2.Primary Outcome
Title Program Completion Rate (%)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description:

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: Percentage of participants
38
3.Secondary Outcome
Title Change in A1c Measurement (%)
Hide Description (Final A1c measure)-(Initial A1c measure)
Time Frame Day 0 and Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Lack of study resources to collect sufficient information on this variable.
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description:

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Weekly Average of Estimated Glucose Values (EGV) (Average)
Hide Description (Sum of EGV for one week)/(Total number of EGV)
Time Frame up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
Lack of study resources to collect sufficient information on this variable.
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description:

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Medication Dosage (mg/Day; U/Day)
Hide Description (dosage of Rx on Day 180)-(dosage of Rx on Day 0)
Time Frame up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
Lack of study resources to collect adequate information on this variable.
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description:

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Average Age of Participants Who Start Trial (Yrs)
Hide Description (Sum of ages of all enrollees)/(Total number of enrollees)
Time Frame up to three months
Hide Outcome Measure Data
Hide Analysis Population Description
Lack of study resources to collect adequate information on this variable.
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description:

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Average Age of Participants Who Complete Trial (Yrs)
Hide Description (Sum of age of patients who complete)/(Total number who complete)
Time Frame up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
Lack of study resources to collect sufficient data on outcome variable.
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description:

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Race of Participants Who Start the Trial (n)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Lack of study resources to collect sufficient data on outcome variable.
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description:

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Ethnicity of Participants Who Start the Trial (n)
Hide Description Sum of Hispanic or Latino and Sum of Not Hispanic or Latino
Time Frame up to three months
Hide Outcome Measure Data
Hide Analysis Population Description
Lack of study resources to collect sufficient data on outcome variable.
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description:

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Texting With Coaches (Daily Average of Text Messages)
Hide Description (Sum of all text messages)/(Total number of days)
Time Frame up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
Lack of study resources to collect sufficient data on outcome variable.
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description:

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Coaching Participation Rate
Hide Description (Sum of weekly coaching calls completed)/(Total number of weeks)
Time Frame up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
Lack of study resources to collect sufficient data on outcome variable.
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description:

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 8 months
Adverse Event Reporting Description

AE and SAE were monitored in three ways:

  • Participants were instructed to call the study doctor's clinical research coordinator (CRC) to report all AE and SAE related to the study devices.
  • Study coaches listened for any reports of AE or SAE in their communications with participants and connected reporting patients with the CRC.
  • Reports of AE or SAE received by Dexcom's Customer Care and Technical Support representatives were documented and reported to the Sponsor and CRC.
 
Arm/Group Title Diabetes Management Educational Program
Hide Arm/Group Description

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

Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.

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.

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.

All-Cause Mortality
Diabetes Management Educational Program
Affected / at Risk (%)
Total   0/52 (0.00%) 
Hide Serious Adverse Events
Diabetes Management Educational Program
Affected / at Risk (%)
Total   0/52 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diabetes Management Educational Program
Affected / at Risk (%)
Total   2/52 (3.85%) 
Skin and subcutaneous tissue disorders   
Bleeding  [1]  1/52 (1.92%) 
Pain  [2]  1/52 (1.92%) 
Indicates events were collected by systematic assessment
[1]
Bleeding at CGM sensor insertion site.
[2]
Pain at CGM sensor insertion site
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jared Jones, PhD
Organization: Savvysherpa, Inc.
Phone: 7635493540 ext 8116
EMail: JaredJones@savvysherpa.com
Layout table for additonal information
Responsible Party: Savvysherpa, Inc.
ClinicalTrials.gov Identifier: NCT03252964    
Other Study ID Numbers: Pro00021722
First Submitted: August 9, 2017
First Posted: August 17, 2017
Results First Submitted: October 2, 2018
Results First Posted: May 1, 2019
Last Update Posted: May 24, 2019