Evaluation of an Ascensia Blood Glucose Meter and App System

NCT ID: NCT02568384

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2015-11-30

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.

Conditions

Diabetes Mellitus

Study Design

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

Study Groups

Users of Onyx BG Meter / App System

Subjects with diabetes used the Onyx Blood Glucose (BG) Meter / App System at home. The enrollment goal for the intended use population:

1. 40 to 70% of subjects will have type 1 diabetes

2. Not more than 30% of subjects will use an insulin pump

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 software operations, ease of use of the system, and clarity and utility of user instructions.

Interventions

Onyx BG Meter / App System

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.

Intervention Type: DEVICE

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

• 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 Inc.

Locations

AMCR Institute

Escondido, California, United States

Countries

United States

Other Identifiers

GCA-2014-006-01

Identifier Type: -

Identifier Source: org_study_id