Evaluation of an Ascensia Blood Glucose Meter and App System
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.
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Oct 2015
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 2, 2015
CompletedFirst Posted
Study publicly available on registry
October 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
August 25, 2017
CompletedAugust 25, 2017
August 1, 2017
1 month
October 2, 2015
December 30, 2016
August 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
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
3 weeks
Other Outcomes (4)
HbA1c% From Study Start to End of Study
3 weeks
Average Change in Subject Fructosamine From Study Start to End of Study
3 weeks
Average Change in Subject Body Weight From Study Start to End of Study
3 weeks
- +1 more other outcomes
Study Arms (1)
Users of Onyx BG Meter / App System
EXPERIMENTALSubjects 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Proliferative retinopathy or history of retinal laser surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AMCR Institute
Escondido, California, 92025, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jane Wallace, Deputy Director for Global Clinical Affairs
- Organization
- Ascensia Diabetes Care
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Bailey, MD
AMCR Institute Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2015
First Posted
October 5, 2015
Study Start
October 1, 2015
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
August 25, 2017
Results First Posted
August 25, 2017
Record last verified: 2017-08