Trial Outcomes & Findings for Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System (NCT NCT01111370)

Results Overview

The proportion of G4 System values within (±) 20% of YSI reference value for glucose levels \>80 mg/dL and (±) 20 mg/dL at YSI glucose levels \<80 mg/dL. This is primarayly laboratory measurement outcome,and it is not measured by clinical outcome, for example, diagnosis, treatement and complication, and clinical effectiveness, etc.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Assessment done on either Day 1, 4 or 7 of the sensor wear period

Results posted on

2017-03-27

Participant Flow

Clinical Research Centers during 12-Mar-2010 to 09-Apr-2010.

Prospective study- the investigator does not assign specific interventions to the subjects of the study in terms of their diabetes management.

Participant milestones

Participant milestones
Measure	Continuous Glucose Monitoring System DexCom™ G4 Continuous Glucose Monitoring System : Continuous Glucose Monitoring System, that is a glucose monitoring device indicated for detecting trends and tracking patterns in persons with diabetes. The system is intended for single patient use and requires a prescription.
Overall Study STARTED	60
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Glucose Monitoring System n=60 Participants The Dexcom G4 Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons with diabetes. The system is intended for single patient use and requires a prescription.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	44 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessment done on either Day 1, 4 or 7 of the sensor wear period

Population: Randomly enrolled

The proportion of G4 System values within (±) 20% of YSI reference value for glucose levels \>80 mg/dL and (±) 20 mg/dL at YSI glucose levels \<80 mg/dL. This is primarayly laboratory measurement outcome,and it is not measured by clinical outcome, for example, diagnosis, treatement and complication, and clinical effectiveness, etc.

Outcome measures

Outcome measures
Measure	CGM Device n=60 Participants DexCom™ G4 Continuous Glucose Monitoring System
the Proportion of G4 CGM System in Agreement With the Reference Standard	80 %20/20 Interval 78.0 to 82.0

Adverse Events

Real Time Continuous Glucose Monitoring System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andy Balo/Sr. VP

Dexcom, Inc

Phone: 8582000203

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER