Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
Launched by DEXCOM, INC. · Aug 23, 2016
Trial Information
Current as of June 20, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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
About Dexcom, Inc.
Dexcom, Inc. is a leading medical device company specializing in continuous glucose monitoring (CGM) systems for individuals with diabetes. Founded in 1999, Dexcom is committed to enhancing diabetes management through innovative technology that provides real-time glucose data, enabling patients and healthcare providers to make informed treatment decisions. With a focus on improving patient outcomes and quality of life, Dexcom's products are designed to deliver accurate, reliable, and user-friendly solutions. The company is dedicated to advancing diabetes care through ongoing research, development, and clinical trials, ensuring that its offerings meet the evolving needs of patients and healthcare professionals alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Portland, Oregon, United States
Boston, Massachusetts, United States
Aurora, Colorado, United States
Escondido, California, United States
Palo Alto, California, United States
Santa Barbara, California, United States
Walnut Creek, California, United States
Atlanta, Georgia, United States
Seattle, Washington, United States
Patients applied
Trial Officials
David PRice, MD
Study Director
DexCom, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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