Trials / Unknown
UnknownNCT02932514
Home Use Sensor Study
Home Use Sensor (HOUSE) Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Senseonics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical investigation is to evaluate the accuracy of the Eversense Continuous Glucose Monitoring System (Eversense System) measurements when compared with a Self-monitoring blood glucose (SMBG) meter. The investigation will assess device performance in two insertion locations (abdomen and upper arm), evaluate safety of the Eversense System usage, and assess the usability of the Eversense system in the hands of user at home setting. Changes in HbA1c from baseline will also be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Eversense (Senseonics) Continuous Glucose Monitoring System | * Evaluate accuracy of Eversense CGM System to SMBG Meter. * Compare performance between abdomen and arm insertion sites. * Determine the usability of the Eversense System in a home-use setting for 180 days. |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2017-07-01
- First posted
- 2016-10-13
- Last updated
- 2017-05-22
Locations
2 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT02932514. Inclusion in this directory is not an endorsement.