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Trials / Completed

CompletedNCT02371876

Evaluation of an Ascensia Diabetes Care ONYX PLUS Investigational Blood Glucose Monitoring System

User Performance of the ONYX PLUS Blood Glucose Monitoring System

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
134 (actual)
Sponsor
Ascensia Diabetes Care · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study was to determine if untrained subjects with diabetes can operate the Investigational ONYX PLUS Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Conditions

Interventions

TypeNameDescription
DEVICEONYX PLUS Investigational Blood Glucose Monitoring SystemUntrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.

Timeline

Start date
2015-02-01
Primary completion
2015-03-01
Completion
2015-03-01
First posted
2015-02-26
Last updated
2019-10-30
Results posted
2017-01-13

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02371876. Inclusion in this directory is not an endorsement.

Evaluation of an Ascensia Diabetes Care ONYX PLUS Investigational Blood Glucose Monitoring System (NCT02371876) · Clinical Trials Directory