NCT02696252CompletedNot Applicable
Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- DexCom, Inc.
- Enrollment
- 97
- Locations
- 4
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Time Frame: 7 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
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