N/A Completed N=376 Diagnostic

Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System

Diabetes

Source: ClinicalTrials.gov NCT02390167 ↗

Enrolled (actual)

376

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcomePrimary: 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 — 99.4 Percent of Results within 15mg/dL/15%

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	99.4	—
SECONDARY 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	97.2	—
SECONDARY 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	99.7	—
SECONDARY 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	100	—
SECONDARY Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range	99.5	—
SECONDARY Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range	99.7	—
SECONDARY Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range	96.7	—
SECONDARY Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range	98.6	—
SECONDARY Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Tested By Study Staff	99.7	—
SECONDARY Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Tested By Study Staff	100	—
SECONDARY 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	98.5	—
SECONDARY Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS	97.9; 98.2; 99.7; 97.3; 97.9; 97.6	—
SECONDARY Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS	98.1; 98.4; 99.7; 97.6; 98.1; 97.6	—
SECONDARY 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	100; 99.70; 99.40; 99.69; 99.70; 99.40	—
SECONDARY 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	99.7	—
SECONDARY 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	97.0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02390167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.