NCT03165110

Evaluation of an Ascensia Diabetes Care Blood Glucose Meter and App System

US ONYX 2.0 Study: A Clinical Study of the Onyx 2.0 System for Blood Glucose Monitoring in Patients With Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the utility of the Contour Diabetes App 2.0 when used with the Contour Next One meter (the Onyx system).

Detailed description

The purpose of this study is to assess the utility of the Contour Diabetes App 2.0 when used with the Contour Next One meter (the Onyx system) in the hands of subjects with type 1 diabetes or insulin-using subjects with type 2 diabetes. It is designed to determine the subjects' self-reported success in utilizing the features of the system. Each feature will be evaluated independently, by including a series of statements about each feature set for which a numerical score or rating will be provided by subjects.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Onyx BG Meter / App System	Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.

Timeline

• Start date: 2017-03-17
• Primary completion: 2017-05-12
• Completion: 2017-05-12
• First posted: 2017-05-24
• Last updated: 2019-06-04
• Results posted: 2019-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study