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

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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.

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 358
Recruitment Details  
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 358
Completed 193
Not Completed 165
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 358
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 356 participants
71.4  (7.6)
[1]
Measure Analysis Population Description: Two participants lacked age data.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 355 participants
Female
184
  51.8%
Male
171
  48.2%
[1]
Measure Analysis Population Description: Three participants lacked gender data.
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.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 358 participants
358
1.Primary Outcome
Title Program Enrollment Rate (%)
Hide Description (Number of patients who were shipped devices) / (Number of patients invited to enroll) * 100
Time Frame up to 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Note that the number analyzed is greater than the number of participants (358) because participants are a subset of those who were invited to participate.
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 5896
Measure Type: Number
Unit of Measure: percentage of invitees
6.1
2.Primary Outcome
Title Program Completion Rate (%)
Hide Description (Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100
Time Frame up to 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
Unit of measure, below, should read, "percentage of participants completing 10 weeks of CGM," but there is not enough space.
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 358
Measure Type: Number
Unit of Measure: percentage of participants
54
3.Secondary Outcome
Title Weekly Average of Estimated Glucose Values (EGV)
Hide Description (Sum of EGV for a given week) / (Total number of EGV for a given week)
Time Frame up to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
358 Participants started the study, but participants dropped out as time passed. By week 10, there were only 193 participants remaining who were providing EGV.
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 358
Mean (Standard Deviation)
Unit of Measure: milligrams/deciliter
Week 1 Number Analyzed 358 participants
153.9  (59.7)
Week 2 Number Analyzed 286 participants
152.7  (57.9)
Week 3 Number Analyzed 275 participants
152.3  (57.1)
Week 4 Number Analyzed 266 participants
152.9  (57.4)
Week 5 Number Analyzed 254 participants
151.5  (54.2)
Week 6 Number Analyzed 242 participants
151.1  (52.3)
Week 7 Number Analyzed 225 participants
149.9  (52.3)
Week 8 Number Analyzed 219 participants
149.4  (54.1)
Week 9 Number Analyzed 210 participants
151.0  (55.6)
Week 10 Number Analyzed 193 participants
149.6  (54.2)
4.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 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
After starting the study, administrator realized that it would not be able to obtain medication data from participants. There is no data to report for this measure.
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 Average Age of Participants Who Start Trial (Yrs)
Hide Description (Sum of ages of all enrollees) / (Total number of enrollees)
Time Frame up to 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Two of the 358 participants who started the study lacked age data.
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 356
Mean (Standard Deviation)
Unit of Measure: years
71.4  (7.6)
6.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 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
One of the 193 participants who completed 10 weeks of CGM use lacked age data.
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 192
Mean (Standard Deviation)
Unit of Measure: years
70.6  (6.5)
7.Secondary Outcome
Title Texting With Coaches
Hide Description (Sum of all text messages) / (Total number of participants*days)
Time Frame up to 11 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 358
Measure Type: Number
Unit of Measure: text messages per participant per day
0.003
8.Secondary Outcome
Title Coaching Participation Rate
Hide Description (Sum of weekly coaching calls completed) / (Total number of participants*weeks)
Time Frame up to 11 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 358
Measure Type: Number
Unit of Measure: calls per participant per week
0.46
Time Frame 10 weeks per participant
Adverse Event Reporting 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.

All-Cause Mortality
Diabetes Management Educational Program
Affected / at Risk (%)
Total   2/358 (0.56%)    
Hide Serious Adverse Events
Diabetes Management Educational Program
Affected / at Risk (%) # Events
Total   3/358 (0.84%)    
Cardiac disorders   
Death from Cardiopulmonary Arrest *  1/358 (0.28%)  1
Death from artherosclerotic and hypertensive heart disease *  1/358 (0.28%)  1
Vascular disorders   
Stroke *  1/358 (0.28%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diabetes Management Educational Program
Affected / at Risk (%) # Events
Total   10/358 (2.79%)    
Injury, poisoning and procedural complications   
Bleeding at Insertion Site *  6/358 (1.68%)  6
Bruising at Insertion Site *  2/358 (0.56%)  2
Product Issues   
Detached/Broken Sensor Wire *  1/358 (0.28%)  1
Skin and subcutaneous tissue disorders   
Redness/Rash at insertion site *  1/358 (0.28%)  1
*
Indicates events were collected by non-systematic assessment
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
Organization: Savvysherpa, LLC
Phone: 763-549-3540 ext 8116
EMail: JaredJones@savvysherpa.com
Layout table for additonal information
Responsible Party: Savvysherpa, Inc.
ClinicalTrials.gov Identifier: NCT03290768    
Other Study ID Numbers: Pro00022589
First Submitted: September 19, 2017
First Posted: September 25, 2017
Results First Submitted: May 23, 2019
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019