Trials / Completed
CompletedNCT02880267
Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 304 (actual)
- Sponsor
- DexCom, Inc. · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CGM | Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement. |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2017-07-01
- Completion
- 2017-09-01
- First posted
- 2016-08-26
- Last updated
- 2018-12-31
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02880267. Inclusion in this directory is not an endorsement.