Trial Outcomes & Findings for Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3) (NCT NCT03290768)

NCT ID: NCT03290768

Last Updated: 2021-05-18

Results Overview

(Number of patients who were shipped devices) / (Number of patients invited to enroll) \* 100

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 358 participants
• Primary outcome timeframe: up to 9 months
• Results posted on: 2021-05-18

Participant Flow

Participant milestones

Measure	Diabetes Management Educational Program 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 Study STARTED	358
Overall Study COMPLETED	193
Overall Study NOT COMPLETED	165

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two participants lacked age data.

Baseline characteristics by cohort

Measure	Diabetes Management Educational Program n=358 Participants 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.
Age, Continuous	71.4 years STANDARD_DEVIATION 7.6 • n=356 Participants • Two participants lacked age data.
Sex: Female, Male Female	184 Participants n=355 Participants • Three participants lacked gender data.
Sex: Female, Male Male	171 Participants n=355 Participants • Three participants lacked gender data.
Region of Enrollment United States	358 participants n=358 Participants

PRIMARY outcome

Timeframe: up to 9 months

Population: 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.

(Number of patients who were shipped devices) / (Number of patients invited to enroll) * 100

Outcome measures

Measure

Diabetes Management Educational Program n=5896 Participants 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.

Program Enrollment Rate (%)

6.1 percentage of invitees

PRIMARY outcome

Timeframe: up to 9 months

Population: Unit of measure, below, should read, "percentage of participants completing 10 weeks of CGM," but there is not enough space.

(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100

Outcome measures

Measure

Diabetes Management Educational Program n=358 Participants 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.

Program Completion Rate (%)

54 percentage of participants

SECONDARY outcome

Timeframe: up to 10 weeks

Population: 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.

(Sum of EGV for a given week) / (Total number of EGV for a given week)

Outcome measures

Measure	Diabetes Management Educational Program n=358 Participants 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.
Weekly Average of Estimated Glucose Values (EGV) Week 1	153.9 milligrams/deciliter Standard Deviation 59.7
Weekly Average of Estimated Glucose Values (EGV) Week 2	152.7 milligrams/deciliter Standard Deviation 57.9
Weekly Average of Estimated Glucose Values (EGV) Week 3	152.3 milligrams/deciliter Standard Deviation 57.1
Weekly Average of Estimated Glucose Values (EGV) Week 4	152.9 milligrams/deciliter Standard Deviation 57.4
Weekly Average of Estimated Glucose Values (EGV) Week 5	151.5 milligrams/deciliter Standard Deviation 54.2
Weekly Average of Estimated Glucose Values (EGV) Week 6	151.1 milligrams/deciliter Standard Deviation 52.3
Weekly Average of Estimated Glucose Values (EGV) Week 7	149.9 milligrams/deciliter Standard Deviation 52.3
Weekly Average of Estimated Glucose Values (EGV) Week 8	149.4 milligrams/deciliter Standard Deviation 54.1
Weekly Average of Estimated Glucose Values (EGV) Week 9	151.0 milligrams/deciliter Standard Deviation 55.6
Weekly Average of Estimated Glucose Values (EGV) Week 10	149.6 milligrams/deciliter Standard Deviation 54.2

SECONDARY outcome

Timeframe: up to 9 months

Population: 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.

(dosage of Rx on Day 180) - (dosage of Rx on Day 0)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 9 months

Population: Two of the 358 participants who started the study lacked age data.

(Sum of ages of all enrollees) / (Total number of enrollees)

Outcome measures

Measure

Diabetes Management Educational Program n=356 Participants 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.

Average Age of Participants Who Start Trial (Yrs)

71.4 years Standard Deviation 7.6

SECONDARY outcome

Timeframe: up to 9 months

Population: One of the 193 participants who completed 10 weeks of CGM use lacked age data.

(Sum of age of patients who complete) / (Total number who complete)

Outcome measures

Measure

Diabetes Management Educational Program n=192 Participants 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.

Average Age of Participants Who Complete Trial (Yrs)

70.6 years Standard Deviation 6.5

SECONDARY outcome

Timeframe: up to 9 months

(Sum of all text messages) / (Total number of participants*days)

Outcome measures

Measure

Diabetes Management Educational Program n=358 Participants 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.

Texting With Coaches

0.003 text messages per participant per day

SECONDARY outcome

Timeframe: up to 9 months

(Sum of weekly coaching calls completed) / (Total number of participants*weeks)

Outcome measures

Measure

Diabetes Management Educational Program n=358 Participants 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.

Coaching Participation Rate

0.46 calls per participant per week

Adverse Events

Diabetes Management Educational Program

Serious events: 3 serious events

Other events: 10 other events

Deaths: 2 deaths

Serious adverse events

Measure	Diabetes Management Educational Program n=358 participants at risk 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.
Cardiac disorders Death from Cardiopulmonary Arrest	0.28% 1/358 • Number of events 1 • 10 weeks per participant
Vascular disorders Stroke	0.28% 1/358 • Number of events 1 • 10 weeks per participant
Cardiac disorders Death from artherosclerotic and hypertensive heart disease	0.28% 1/358 • Number of events 1 • 10 weeks per participant

Other adverse events

Measure	Diabetes Management Educational Program n=358 participants at risk 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.
Injury, poisoning and procedural complications Bleeding at Insertion Site	1.7% 6/358 • Number of events 6 • 10 weeks per participant
Injury, poisoning and procedural complications Bruising at Insertion Site	0.56% 2/358 • Number of events 2 • 10 weeks per participant
Product Issues Detached/Broken Sensor Wire	0.28% 1/358 • Number of events 1 • 10 weeks per participant
Skin and subcutaneous tissue disorders Redness/Rash at insertion site	0.28% 1/358 • Number of events 1 • 10 weeks per participant

Additional Information

Jared Jones

Savvysherpa, LLC

Phone: 763-549-3540

Email: JaredJones@savvysherpa.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place