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

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: ONYX PLUS Investigational Blood Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02371876

GCA-2014-005-01

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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 BG monitor study using the 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

The enrollment goal for the intended use population:

1. At least 70% of subjects will be younger than age 65
2. At least 20% of subjects 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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134 participants in 1 patient group

Users of the Monitoring System

Experimental group

Description:

Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.

Treatment:

Device: ONYX PLUS Investigational Blood Glucose Monitoring System