Trials / Unknown
UnknownNCT03851549
A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)
US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- LifeScan Scotland Ltd · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).
Detailed description
User Performance - Assess Lay User fingertip test results obtained on the new BGMS compared to a validated method (YSI 2300 STAT PLUS glucose analyzer results) according to FDA Guidance 2016 section VI.C. Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | New BGMS (US) | New blood glucose monitoring system / In vitro diagnostic device (IVDD) |
Timeline
- Start date
- 2019-03-12
- Primary completion
- 2019-04-19
- Completion
- 2019-04-19
- First posted
- 2019-02-22
- Last updated
- 2019-03-08
Locations
4 sites across 2 countries: Germany, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03851549. Inclusion in this directory is not an endorsement.