G5® Mobile Continuous Glucose Monitoring System Automated vs. Manual Sensor Applicator

Dexcom

Status: Completed

Conditions: Diabetes Mellitus

Study type: Observational

Funder types: Industry

Identifiers

NCT02696252

PTL-901800

Details and patient eligibility

About

Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator

Full description

The objective of the study is to demonstrate the performance, i.e. efficacy of the G5x System with the automated applicator is no worse than that of the commercial Dexcom G4 TM PLATINUM Continuous Glucose Monitoring System (G4 System) with the manual applicator.

Enrollment: 97 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 2 or older
• Diagnosis of Type 1 diabetes or Type 2 diabetes
• Willing to participate in a clinic session involving venous sampling for evaluation of study end point

Exclusion criteria

• Use of acetaminophen
• Known allergy to medical-grade adhesives
• Pregnancy
• Hematocrit outside specification of the study-assigned blood glucose meter

Trial design

97 participants in 1 patient group

CGM Users