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DiabetesNCT02390167

Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System

A study testing ONYX NEXT BGMS in people with Diabetes, run by Ascensia Diabetes Care at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to determine if untrained subjects with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes
What is being tested?
ONYX NEXT BGMS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
2 sitesUnited States
Study dates
Mar 2015to Apr 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males and females, 18 years of age and older
  • Able to speak, read, and understand English
  • Willing to complete all study procedures

Who cannot join

  • Hemophilia or any other bleeding disorder
  • Pregnancy
  • Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM
  • Previously participated in a blood glucose monitoring study using the ONYX NEXT or ONYX PLUS BGMS
  • Working for a medical laboratory, hospital, or other clinical setting that involves training on or clinical use of blood glucose monitors
  • Working for a competitive medical device company, or having an immediate family member who works for such a company
Show all 11Show fewer
  • A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
  • General enrollment guidelines:
  • At least 70% of subjects will be younger than age 65
  • At least 10% (approximately 10-15%) of subjects will be naive users
  • At least 20% of subjects with diabetes will have type 1 diabetes

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • AMCR Institute

    Escondido, California, 92026

  • Diablo Clinical Research

    Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: User Performance of the ONYX NEXT Blood Glucose Monitoring System

The purpose of this study was to determine if untrained subjects with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Conditions
Diabetes
Being tested
ONYX NEXT BGMS
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONYX NEXT BGMSDevice

    Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested venous blood from subjects WITH Diabetes and BG results were compared to reference method results obtained from the subjects' venous plasma.

Study groups in NCT02390167
Study groupRoleWhat they receive
Persons With DiabetesExperimentalUntrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).
Receives: Device: ONYX NEXT BGMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method

    Untrained subjects WITH Diabetes (332) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).

    Measured: 1 hour

Secondary outcomes (15)

  1. Percent of Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method

    Untrained subjects WITH Diabetes (332) self-tested Alternate Site (AST) palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).

    Measured: 1 hour

  2. Percent of Subject Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff

    Study staff tested subject (332 WITH diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).

    Measured: 1 hour

  3. Percent of Venous Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff

    Study staff tested venous blood of 332 subjects WITH diabetes using an Investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI venous plasma) and +/- 15% (>=100 mg/dL YSI venous plasma).

    Measured: 1 hour

  4. Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range

    Untrained subjects WITH Diabetes (332) and WITHOUT Diabetes (43) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.

    Measured: 1 hour

  5. Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range

    Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested Fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.

    Measured: 1 hour

  6. Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range

    Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.

    Measured: 1 hour

  7. Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range

    Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.

    Measured: 1 hour

  8. Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Tested By Study Staff

    Study staff tested subject (332 WITH and 43 WITHOUT diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory method across the entire tested YSI glucose range.

    Measured: 1 hour

  9. Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Tested By Study Staff

    Study staff tested subject (332 WITH and 43 WITHOUT diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory method across the entire tested YSI glucose range.

    Measured: 1 hour

  10. Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100 mg/dL) of Laboratory Glucose Method

    Untrained subjects WITH Diabetes (332) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 12.5 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 12.5% (>=100 mg/dL YSI capillary plasma).

    Measured: 1 hour

  11. Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS

    Staff obtained responses from persons WITH Diabetes (332) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.

    Measured: 1 hour

  12. Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS

    Staff obtained responses from persons WITH and WITHOUT Diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.

    Measured: 1 hour

  13. Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose

    Staff obtained responses from persons WITH Diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'Choose Not to Answer'.

    Measured: 1 hour

  14. Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method

    Untrained subject WITH and WITHOUT diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (< 75 mg/dL YSI capillary plasma) and +/- 15% (>= 75 mg/dL YSI capillary plasma).

    Measured: 1 hour

  15. Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method

    Untrained subject WITH and WITHOUT diabetes self-tested Alternate Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (< 75 mg/dL YSI capillary plasma) and +/- 15% (>= 75 mg/dL YSI capillary plasma).

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02390167
Sponsor's protocol ID
GCA-PRO-2014-004-01
Status last verified
Mar 2017
First submitted
11 Mar 2015
Last updated
17 Jul 2019
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ONYX NEXT BGMS in people with Diabetes, run by Ascensia Diabetes Care at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02390167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.

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