Trial Outcomes & Findings for Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm (NCT NCT02087995)

NCT ID: NCT02087995

Last Updated: 2017-08-24

Results Overview

The percentage of CGM system values that are within 20% of the reference value for YSI glucose levels \> 80 mg/dL or within 20 mg/dL at the reference glucose levels \< 80 mg/dL.

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

7-day wear period

Results posted on

2017-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	Real Time Continuous Glucose Monitoring System Real Time Continuous Glucose Monitoring System Wear over a 7 day period
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Real Time Continuous Glucose Monitoring System n=51 Participants Real Time Continuous Glucose Monitoring System Wear over a 7 day period
Age, Continuous	46.7 years old STANDARD_DEVIATION 15.8 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 7-day wear period

Population: For the demographic and other baseline characteristic information, data from all 51 enrolled subjects was summarized.

The percentage of CGM system values that are within 20% of the reference value for YSI glucose levels \> 80 mg/dL or within 20 mg/dL at the reference glucose levels \< 80 mg/dL.

Outcome measures

Outcome measures
Measure	Real Time Continuous Glucose Monitoring System n=51 Participants Real Time Continuous Glucose Monitoring System Wear over a 7 day period
The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement.	93 Units analyzed% matched pairs w/i %20/20

Adverse Events

Real Time Continuous Glucose Monitoring System

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Real Time Continuous Glucose Monitoring System n=51 participants at risk Real Time Continuous Glucose Monitoring System Wear over a 7 day period
Skin and subcutaneous tissue disorders Blister, skin	2.0% 1/51 • Number of events 1 • 7 days of continuous glucose monitoring system use. AEs assessed for all participants enrolled into the study

Additional Information

Andrew Balo/ EVP

Dexcom, Inc

Phone: 8582000203

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place