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Evaluation of an Ascensia Blood Glucose Meter and App System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568384
Recruitment Status : Completed
First Posted : October 5, 2015
Results First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Ascensia Diabetes Care

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Onyx BG Meter / App System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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.
Study Start Date : October 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: 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
Device: 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.




Primary Outcome Measures :
  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. [ Time Frame: 3 weeks ]

    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 3 weeks ]
    Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the basic operation of the Onyx Glucose Meter and App System. Subjects could respond '1Very Simple' or '2Simple' or '3Neither Simple nor Difficult' or '4Difficult' or '5Very Difficult' or '6No Opinion'.

  2. 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 [ Time Frame: 3 weeks ]
    Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the clarity and utility of user instructions 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'.


Other Outcome Measures:
  1. HbA1c% From Study Start to End of Study [ Time Frame: 3 weeks ]
    Laboratory reports were used to compare HbA1c results from subjects at visit 1 with HbA1c results at Visit 2 (end of study).

  2. Average Change in Subject Fructosamine From Study Start to End of Study [ Time Frame: 3 weeks ]
    Laboratory reports were used to compare Fructosamine results from subjects at visit 1 with Fructosamine results at Visit 2 (end of study).

  3. Average Change in Subject Body Weight From Study Start to End of Study [ Time Frame: 3 weeks ]
    Subject Body Weight results at visit 1 were compared with Body Weight results at Visit 2 (end of study).

  4. Average Change in Total Daily Insulin Dose From Study Start to End of Study [ Time Frame: 3 weeks ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568384


Locations
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United States, California
AMCR Institute
Escondido, California, United States, 92025
Sponsors and Collaborators
Ascensia Diabetes Care
Investigators
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Principal Investigator: Timothy Bailey, MD AMCR Institute Inc.
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Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT02568384    
Other Study ID Numbers: GCA-2014-006-01
First Posted: October 5, 2015    Key Record Dates
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases