Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System

NCT02390167 | Completed Results

• 1 other identifier: GCA-PRO-2014-004-01
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method

  Untrained subjects WITH Diabetes (332) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (\<100 mg/dL YSI capillary plasma) and +/- 15% (\>=100 mg/dL YSI capillary plasma).

  1 hour

Secondary Outcomes (15)

• Percent of Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method

  1 hour

• Percent of Subject Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff

  1 hour

• Percent of Venous Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff

  1 hour

• Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range

  1 hour

• Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range

  1 hour

Study Arms (1)

Persons With Diabetes

EXPERIMENTAL

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

Device: ONYX NEXT BGMS

Interventions

ONYX NEXT BGMS 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.

Persons With Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (2)

AMCR Institute

Escondido, California, 92026, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Jane Wallace, Deputy Director for Global Clinical Affairs
• Organization: Ascensia Diabetes Care

jane.wallace@ascensia.com

574-257-3063

Study Officials

• Timothy Bailey, MD, FACP

  AMCR Institute

  PRINCIPAL INVESTIGATOR

• Mark Christiansen, MD

  Diablo Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 17, 2019
• Results First Posted: April 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)