Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT02880267
Status:
COMPLETED
Last Update Posted:
2018-12-31
First Post:
2016-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
Sponsor:
DexCom, Inc.
Organization:
Study Overview
Official Title:
Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
The safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: