Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
- Conditions
- Diabetes Mellitus
- Interventions
- Device: CGM
- Registration Number
- NCT02880267
- Lead Sponsor
- DexCom, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
- 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
- Use of acetaminophen
- Known allergy to medical-grade adhesives
- Pregnancy
- Hematocrit outside specification of the study-assigned blood glucose meter
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CGM Users CGM Glucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Rainier
🇺🇸Seattle, Washington, United States
Stanford
🇺🇸Palo Alto, California, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Oregon Health Science University
🇺🇸Portland, Oregon, United States
Sansum
🇺🇸Santa Barbara, California, United States
Atlanta Diabetes
🇺🇸Atlanta, Georgia, United States
AMCR Institute
🇺🇸Escondido, California, United States
Diablo
🇺🇸Walnut Creek, California, United States
Barbara Davis Center
🇺🇸Aurora, Colorado, United States