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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02696252

Enrollment

Registered

2016-03-02

Start date

2016-01-31

Completion date

2016-04-30

Last updated

2016-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a diabetes accuracy measurement of %20/20 mg/dL	7 days

Countries

United States

Outcome results