Diabetes Mellitus
Conditions
Brief summary
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System
Detailed description
The objective of the study is to establish performance of the System compared to a laboratory reference measurement. The effectiveness of the System will be evaluated by comparison of CGM values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous sample measurements. Performance will be evaluated in terms of point and rate accuracy of the System in reference to YSI. The safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.
Interventions
DEVICECGM
Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.
Sponsors
DexCom, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages 2 or older * Diagnosis of Type 1 diabetes or Type 2 diabetes, on intensive insulin therapy * 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 proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL | 10 Days |
Countries
United States
Outcome results
None listed