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

US ONYX 2.0 Study: A Clinical Study of the Onyx 2.0 System for Blood Glucose Monitoring in Patients With Diabetes

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Onyx BG Meter / App 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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Escondido, California, United States, 92026
      • AMCR Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Onyx BG Meter / App System; Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Responses From Persons With Diabetes That 'Strongly Agree' or 'Agree' or 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success With Syncing the Reading on the Onyx Glucose Meter and App.	Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the success of syncing the blood glucose value on the meter with the App 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'.	6 weeks
Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success in Accessing and Using Smart Reminders Feature in the Onyx App System	Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on accessing and using the Smart Reminders feature in the Onyx App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.Recognize and use "Smart Reminders"	6 weeks
Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success at Accessing the Expanded Graph and My Readings View in the Onyx App System	Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the subjects ability to access the Expanded Graph and My Readings views in Onyx App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.	6 weeks
Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success in Interpreting the Expanded Graph and My Readings View in the Onyx App System	Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the subjects ability to interpret the Expanded Graph and My Readings views in Onyx the App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c% From Study Start to End of Study	Laboratory reports were used to compare HbA1c results from subjects at visit 1 with HbA1c results at Visit 2 (end of study). The average change of HbA1c for all subjects at Visit 1 were compared to the average change of HbA1c for all subjects at Visit 2. Lower scores are better outcomes.	6 weeks
Change in Fructosamine (µmol/L) From Study Start to End of Study	Laboratory reports were used to compare fructosamine results from subjects at visit 1 with frustosamine results at Visit 2 (end of study).	6 Weeks
Average Change in Subject Body Weight From Study Start to End of Study	The average change in subject body weight from study start (Visit 1) to end of study (Visit 2).	6 weeks
Average Change in Subject BMI From Study Start to End of Study	Subject BMI results at visit 1 were compared with BMI results at Visit 2 (end of study).	6 weeks
Average Change in Total Daily Insulin Dose From Study Start to End of Study	A Subjects' self-reported Total Daily Insulin Doses at visit 1 were compared with their self-reported Total Daily Insulin Doses at Visit 2 (end of study).	6 weeks

Collaborators and Investigators

• Sponsor: Ascensia Diabetes Care

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Actual): May 12, 2017
• Study Completion (Actual): May 12, 2017

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: GCA-PRO-2016-001-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No