User Performance of the ONYX NEXT Blood Glucose Monitoring System

Ascensia Diabetes Care2 sites in 1 country376 target enrollmentMarch 2015

ConditionsDiabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes
Sponsor: Ascensia Diabetes Care
Enrollment: 376
Locations: 2
Primary Endpoint: 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
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

April 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ascensia Diabetes Care

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 1 hour

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).

Secondary Outcomes

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 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 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 +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100 mg/dL) of Laboratory Glucose Method(1 hour)
Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS(1 hour)
Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS(1 hour)
Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range(1 hour)
Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range(1 hour)
Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range(1 hour)
Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Tested By Study Staff(1 hour)
Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Tested By Study Staff(1 hour)
Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose(1 hour)
Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method(1 hour)
Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method(1 hour)