Trials / Unknown
UnknownNCT03935191
Performance of the Dexcom G6 Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (estimated)
- Sponsor
- DexCom, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this prospective observational study is to establish the performance and safety of the Dexcom G6 CGM System utilized for up to a 10-day wear period in pregnant women with diabetes mellitus.
Detailed description
Primary Study Objective: To determine the accuracy of Dexcom G6 CGM System glucose readings in reference to arterialized venous sample YSI glucose measurements in pregnant women with diabetes mellitus. Secondary Study Objective: To assess the safety of the Dexcom G6 CGM System, through characterization of device-related Adverse Events (AEs), in pregnant women with diabetes mellitus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dexcom CGM System | Dexcom CGM System |
Timeline
- Start date
- 2019-05-01
- Primary completion
- 2019-05-31
- Completion
- 2019-05-31
- First posted
- 2019-05-02
- Last updated
- 2019-05-02
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03935191. Inclusion in this directory is not an endorsement.