Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: ONYX NEXT BGMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02390167

GCA-PRO-2014-004-01

Details and patient eligibility

About

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.

Enrollment: 376 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females, 18 years of age and older
• Able to speak, read, and understand English
• Willing to complete all study procedures

Exclusion criteria

• Hemophilia or any other bleeding disorder
• Pregnancy
• Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM
• Previously participated in a blood glucose monitoring study using the ONYX NEXT or ONYX PLUS BGMS
• Working for a medical laboratory, hospital, or other clinical setting that involves training on or clinical use of blood glucose monitors
• Working for a competitive medical device company, or having an immediate family member who works for such a company
• A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk

General enrollment guidelines:

• At least 70% of subjects will be younger than age 65
• At least 10% (approximately 10-15%) of subjects will be naive users
• At least 20% of subjects with diabetes will have type 1 diabetes

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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376 participants in 1 patient group

Persons With Diabetes

Experimental group

Description:

Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Treatment:

Device: ONYX NEXT BGMS