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

NCT ID: NCT02371876

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-03-31

Brief 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

Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Users of the Monitoring System

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

Group Type: EXPERIMENTAL

ONYX PLUS Investigational Blood Glucose Monitoring System

Intervention Type: DEVICE

Untrained 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.

Interventions

ONYX PLUS Investigational Blood Glucose Monitoring System

Untrained 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascensia Diabetes Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

AMCR Institute Inc.

Mark Christiansen, MD

Role: PRINCIPAL_INVESTIGATOR

Diablo Clinical Research

Locations

AMCR Institute

Escondido, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Countries

United States

Other Identifiers

GCA-2014-005-01

Identifier Type: -

Identifier Source: org_study_id