Trials / Completed
CompletedNCT02390167
Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System
User Performance of the ONYX NEXT Blood Glucose Monitoring System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 376 (actual)
- Sponsor
- Ascensia Diabetes Care · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study was to determine if untrained subjects with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ONYX NEXT BGMS | Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested venous blood from subjects WITH Diabetes and BG results were compared to reference method results obtained from the subjects' venous plasma. |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2015-04-01
- Completion
- 2015-04-01
- First posted
- 2015-03-17
- Last updated
- 2019-07-17
- Results posted
- 2017-04-20
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02390167. Inclusion in this directory is not an endorsement.