Clinical trial NCT02568384: Evaluation of an Ascensia Blood Glucose Meter and App System
Official title: Open Label, Single-center Study of the Onyx Meter and App System for Blood Glucose Monitoring in Insulin-Dependent and Insulin-using, Non-Insulin-Dependent Diabetes Mellitus Patients to Demonstrate Usability in a Clinical Setting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2015-10-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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

Primary outcomes:
measure: Percent of Responses From Persons Who Performed Each "Software Operations" Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree.
timeFrame: 3 weeks
Secondary outcomes:
measure: 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
timeFrame: 3 weeks
measure: 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
timeFrame: 3 weeks
Other outcomes:
measure: HbA1c% From Study Start to End of Study
timeFrame: 3 weeks
measure: Average Change in Subject Fructosamine From Study Start to End of Study
timeFrame: 3 weeks
measure: Average Change in Subject Body Weight From Study Start to End of Study
timeFrame: 3 weeks
measure: Average Change in Total Daily Insulin Dose From Study Start to End of Study
timeFrame: 3 weeks
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
Study officials:
affiliation: AMCR Institute Inc.
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References: