Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System

NCT ID: NCT02390167

Last Updated: 2019-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-04-30

Brief Summary

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.

Conditions

Diabetes

Study Design

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

Study Groups

Persons With Diabetes

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

Group Type: EXPERIMENTAL

ONYX NEXT BGMS

Intervention Type: DEVICE

Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested venous blood from subjects WITH Diabetes and BG results were compared to reference method results obtained from the subjects' venous plasma.

Interventions

ONYX NEXT BGMS

Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested venous blood from subjects WITH Diabetes and BG results were compared to reference method results obtained from the subjects' 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ascensia Diabetes Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Bailey, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

AMCR Institute

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-PRO-2014-004-01

Identifier Type: -

Identifier Source: org_study_id