Evaluation of an Ascensia Blood Glucose Meter and App System

Study Overview
=================
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.

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.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Onyx BG Meter / App System


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Users of Onyx BG Meter / App System<br>Subjects with diabetes used the Onyx Blood Glucose (BG) Meter / App System at home. The enrollment goal for the intended use population: 40 to 70% of subjects will have type 1 diabetes Not more than 30% of subjects will use an insulin pump | Device: Onyx BG Meter / App System<br>* Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Responses From Persons Who Performed Each Software Operations Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree. | For software operations tasks, subjects rated statements about software operations tasks as 1Strongly Agree, 2Agree, 3Neither Agree nor Disagree, 4Disagree, 5Strongly Disagree, or 6No opinion. Software operations tasks included: Obtain a synced blood glucose reading Initiation and use of insulin bolus calculator Access and interpret glucose displays such as expanded graph (modal day) and sequential views. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the basic operation of the Onyx Glucose Meter and App System. Subjects could respond '1Very Simple' or '2Simple' or '3Neither Simple nor Difficult' or '4Difficult' or '5Very Difficult' or '6No Opinion'. | 3 weeks | 
| 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 | Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the clarity and utility of user instructions for the Onyx Glucose Meter and App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'. | 3 weeks |