Evaluation of an Ascensia Diabetes Care Blood Glucose Meter and App System

Completed · Not applicable

Conditions studied: Diabetes Mellitus

In brief

The purpose of this study is to assess the utility of the Contour Diabetes App 2.0 when used with the Contour Next One meter (the Onyx system).

Key facts

Study ID

NCT03165110

Run by

Ascensia Diabetes Care

People needed

47

Starts

2017-03-17

Expected to finish

2017-05-12

Last updated by the study team

2019-06-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be aged 18-75 years, male or female
• Read and understand English
• Have diagnosis of type 1 (goal is 40% to 70%) or insulin-using type 2 diabetes for at least 6 months
• Be taking multiple daily insulin injections (MDI) of at least two pre-meal bolus insulin injections daily or using an insulin pump (Goal is not more than 30% of subjects using insulin pump therapy)
• Performing self-monitoring of blood glucose at home at least twice daily
• Have an iOS mobile device or Android mobile device with Bluetooth capability iOS device: iPod, iPad, or iPhone 5 or later version with iOS 9.x or 10.x software Android: smart phone, software version 6.x. Bluetooth: software version 4.0 or higher
• Agree NOT to update the software on their mobile device until after the study is concluded, as follows:
• No updates of Android device to upcoming Android version 7 (Nougat)
• Be willing to utilize the Contour Next One meter and the Contour Diabetes App 2.0 on personal mobile device which communicates to meter to manage diabetes and be willing to keep a study diary

You may not qualify if…

• Known Hemophilia or any other bleeding disorder
• Pregnancy (reported by subject; no pregnancy test required)
• Current user of Contour Next One BGMS including Contour Diabetes App.
• Physical, visual or neurological impairments that would make the person unable to perform testing with the Contour Next One BGMS or to use the Contour Diabetes App
• 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.
• Immediate family members are the subject's parents, spouse, children, and siblings, including the parent's spouse; step children and adopted children and their spouses.
• A competitive medical device company is a company that provides a medical device or components of a device that is related to diabetes. For example, people who are not eligible are those who work for companies that create or manufacture the following (or a company that is in a partnership with a company that provides such devices): lancing devices, blood glucose monitoring systems, continuous glucose monitoring systems, insulin pens, or systems related to the measurement of HbA1c. People who are eligible are those who work for companies associated with products such as wound dressings, medications or dietary products.
• 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).

Where it is running

• AMCR Institute — Escondido, California, United States

Full record on ClinicalTrials.gov

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