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OpenTrials
Completed

NCT Number: NCT02568384

Evaluation of an Ascensia Blood Glucose Meter and App System

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AMCR Institute

Escondido, California, 92025, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Onyx BG Meter / App System

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.

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.

    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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 5, 2015
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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