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NCT02880267 Clinical Trial

Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System

Diabetes Mellitus Clinical Trial

Official title:
Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02880267
Other study ID # PTL-902220
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date September 2017

Study information
Verified date December 2018
Source DexCom, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System

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 information / eligibility
Status Completed
Enrollment 304
Est. completion date September 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CGM
Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.

Locations
Country Name City State
United States Atlanta Diabetes Atlanta Georgia
United States Barbara Davis Center Aurora Colorado
United States Joslin Diabetes Center Boston Massachusetts
United States AMCR Institute Escondido California
United States Stanford Palo Alto California
United States Oregon Health Science University Portland Oregon
United States Sansum Santa Barbara California
United States Rainier Seattle Washington
United States Diablo Walnut Creek California

Sponsors (1)
Lead Sponsor Collaborator
DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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