N/A
Completed N=134
Evaluation of an Ascensia Diabetes Care ONYX PLUS Investigational Blood Glucose Monitoring System
Source: ClinicalTrials.gov NCT02371876 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method — 99.2 Percentage of BG Results
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method |
99.2 | — |
| SECONDARY Percent of Alternate Site Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method |
99.2 | — |
| SECONDARY Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method When Tested by Study Staff |
99.2 | — |
| SECONDARY Percent of Venous Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method |
100 | — |
| SECONDARY Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100mg/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 |
99.2; 98.5; 100; 97.8; 100; 96.3 | — |
| 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 |
99.25; 99.25; 100; 100; 100; 100 | — |
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:
- At least 70% of subjects will be younger than age 65
- At least 20% of subjects will have type 1 diabetes
Data sourced from ClinicalTrials.gov (NCT02371876). 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.