N/A
Completed N=45
Evaluation of an Ascensia Blood Glucose Meter and App System
Source: ClinicalTrials.gov NCT02568384 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Percent of Responses From Persons Who Performed Each "Software Operations" Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree. — 95.4; 89.7; 95.4 Percent of Responses
Summary
The purpose of this study is to assess the usability of the Onyx system in the hands of subjects with Insulin Dependent Diabetes Mellitus (IDDM) or insulin-using subjects with Non-IDDM.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Responses From Persons Who Performed Each "Software Operations" Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree. |
95.4; 89.7; 95.4 | — |
| SECONDARY Percent of Responses From Persons With Diabetes That Rated Ease of Use For Onyx Glucose Meter and App System as Either Very Simple or Simple or Neither Simple Nor Difficult |
97.6; 97.7; 100; 97.6; 97.5; 90.7 | — |
| SECONDARY Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Clarity and Utility of User Instructions For Onyx Glucose Meter and App System |
100; 100; 100 | — |
Eligibility Criteria
Inclusion Criteria
- Be aged 18-75 years, male or female
- Read and understand English
- Have diagnosis of type 1 or insulin-using type 2 diabetes for at least 6 months
- Be taking multiple daily injections (MDI) of at least two pre-meal bolus injections daily or using an insulin pump
- Performing self-monitoring of blood glucose at home at least twice daily
- Have an iOS mobile device or Android mobile device with blue tooth capability
- iOS device: iPod or iPhone 5 or later version with iOS 8.0 software or higher (no tablets)
- Android: smart phone, 4.4 version and higher (no tablets)
- Be willing to utilize the ONYX App on personal mobile device which communicates to meter to manage diabetes (including use of the bolus calculator)
- Be ambulatory and have transportation to the study site
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
- Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone 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 (reason for exclusion will be clearly documented by investigator or designee on the subject disposition form).
- Proliferative retinopathy or history of retinal laser surgery
Data sourced from ClinicalTrials.gov (NCT02568384). 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.