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

NCT ID: NCT03165110

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-17
• Study Completion Date: 2017-05-12

Brief Summary

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).

Detailed Description

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) in the hands of subjects with type 1 diabetes or insulin-using subjects with type 2 diabetes. It is designed to determine the subjects' self-reported success in utilizing the features of the system. Each feature will be evaluated independently, by including a series of statements about each feature set for which a numerical score or rating will be provided by subjects.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Users of the Onyx Blood Glucose Meter/ app System at home

Participants have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin.

Group Type: EXPERIMENTAL

Onyx BG Meter / App System

Intervention Type: DEVICE

Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.

Interventions

Onyx BG Meter / App System

Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascensia Diabetes Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

AMCR Institute

Locations

AMCR Institute

Escondido, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GCA-PRO-2016-001-01

Identifier Type: -

Identifier Source: org_study_id