Trial Outcomes & Findings for Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics (NCT NCT03252964)

NCT ID: NCT03252964

Last Updated: 2019-05-24

Results Overview

(Number of patients who signed a consent form)/(Number of patients invited to enroll)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: up to three months
• Results posted on: 2019-05-24

Participant Flow

364 candidates were contacted. Of those, 52 enrolled.

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	52
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Diabetes Management Educational Program n=52 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, Categorical <=18 years	0 Participants n=52 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=52 Participants
Age, Categorical >=65 years	8 Participants n=52 Participants
Sex: Female, Male Female	26 Participants n=52 Participants
Sex: Female, Male Male	26 Participants n=52 Participants

PRIMARY outcome

Timeframe: up to three months

Population: 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.

(Number of patients who signed a consent form)/(Number of patients invited to enroll)

Outcome measures

Measure

Diabetes Management Educational Program n=364 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 (%)

14 Percentage of participants

PRIMARY outcome

Timeframe: up to six months

(Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)

Outcome measures

Measure

Diabetes Management Educational Program n=52 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 (%)

38 Percentage of participants

SECONDARY outcome

Timeframe: Day 0 and Day 180

Population: Lack of study resources to collect sufficient information on this variable.

(Final A1c measure)-(Initial A1c measure)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to six months

Population: Lack of study resources to collect sufficient information on this variable.

(Sum of EGV for one week)/(Total number of EGV)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to six months

Population: Lack of study resources to collect adequate information on this variable.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to three months

Population: Lack of study resources to collect adequate information on this variable.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to six months

Population: Lack of study resources to collect sufficient data on outcome variable.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to three months

Population: Lack of study resources to collect sufficient data on outcome variable.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to three months

Population: Lack of study resources to collect sufficient data on outcome variable.

Sum of Hispanic or Latino and Sum of Not Hispanic or Latino

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to six months

Population: Lack of study resources to collect sufficient data on outcome variable.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to six months

Population: Lack of study resources to collect sufficient data on outcome variable.

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

Outcome measures

Outcome data not reported

Adverse Events

Diabetes Management Educational Program

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Diabetes Management Educational Program n=52 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.
Skin and subcutaneous tissue disorders Bleeding	1.9% 1/52 • Up to 8 months 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.
Skin and subcutaneous tissue disorders Pain	1.9% 1/52 • Up to 8 months 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.

Additional Information

Jared Jones, PhD

Savvysherpa, Inc.

Phone: 7635493540

Email: JaredJones@savvysherpa.com

Results disclosure agreements

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