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NCT04033315 · ClinicalTrials.gov registry record
Performance of the L-PLUS BGMS by Persons With Diabetes Mellitus
A clinical trial, sponsored by Ascensia Diabetes Care.
- Completed
- Registry status
- 130
- Enrollment target
NCT04033315: Completed study, sponsored by Ascensia Diabetes Care.
NCT04033315 is a clinical trial that has completed, run by Ascensia Diabetes Care. The registered enrollment target is 130 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04033315 has completed, sponsored by Ascensia Diabetes Care.
- COMPLETED
- Registry status
- 130 participants
- Enrollment target
Study Summary
L-PLUS (Lightning PLUS) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and marketed CONTOUR PLUS® test strip. This clinical trial will assess the performance (accuracy) of the L-PLUS meter by lay users with diabetes enrolled as subjects in the study, and by health care professionals (also called study staff). The trial will follow the requirements and procedures described in ISO 15197:2013 International Standard.
Primary Outcome
Accuracy of BGMS test with fingerstick blood. The results of the fingerstick meter test performed by the participant will be compared to results of the same blood on a laboratory reference analyzer using pre-specified accuracy criteria.
Interventions
- DEVICE L-PLUS meter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2019-09-05 |
What the finished NCT04033315 record still lists
NCT04033315 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which L-PLUS meter is the first listed.
NCT04033315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04033315 about?
NCT04033315 is a clinical study titled "Performance of the L-PLUS BGMS by Persons With Diabetes Mellitus". L-PLUS (Lightning PLUS) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and marketed CONTOUR PLUS® test strip. This clinical trial will assess the performance (accuracy) of the L-PLUS meter by lay users with diabetes enrolled as subjects in the study, and by he...
What is the current status of trial NCT04033315?
This trial is currently completed. The enrollment target is 130 participants. The study started on 2019-07-15. Estimated completion is 2019-09-05.
What interventions are being tested in trial NCT04033315?
The interventions under investigation include: L-PLUS meter (DEVICE).
Who is sponsoring clinical trial NCT04033315?
This trial is sponsored by Ascensia Diabetes Care, which has 42 total clinical trials registered on ClinicalTrials.gov.
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