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Blood Glucose MeasurementNCT02810522

OneTouch Select® [Brand Name]Plus Blood Glucose Monitoring System(BGMS) Registration Study

A study testing OneTouch Select® Plus Glucose Test Strips in people with Blood Glucose Measurement, run by Johnson & Johnson Medical, China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is to support the regulatory application of OneTouch Select® Plus test strips in China. The blood glucose test strip is regulated as an In Vitro Diagnostic (IVD) product and China Food and Drug Administration (CFDA) regulation of IVDs should be complied with. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Blood Glucose Measurement
What is being tested?
OneTouch Select® Plus Glucose Test Strips
Type of treatment
Medical device
How many people
0 participants
Where
No sites listed yet
Study dates
31 Aug 2016to 31 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is at least 18 years of age.
  • Subject has a current diagnosis of type 1 or type 2 diabetes mellitus.
  • Subject is currently performing unassisted self-monitoring of blood glucose.
  • Subject agrees to sign two (2) copies each of the Subject Informed Consent Form.
  • Subject agrees to provide relevant demographic, medical history and diabetes management information and agrees to allow study staff access to medical records when necessary.
  • Subject can read and understand Chinese.
  • Subject agrees to complete all aspects of the study including at least one fingertip puncture, one retry in maximum may be performed if insufficient blood collected or an error message is obtained on the first attempt.

Who cannot join

  • Subject is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products.
  • Subject has already participated in this study.
  • Subject is knowingly pregnant.

About this study

Official title: A Registration Study to Assess User Performance of OneTouch Select® Plus Blood Glucose Monitoring System

This study is to support the regulatory application of OneTouch Select® Plus test strips in China. The blood glucose test strip is regulated as an In Vitro Diagnostic (IVD) product and China Food and Drug Administration (CFDA) regulation of IVDs should be complied with. The result of this study will be used to support regulatory filing in China.

Investigational Product:

Read more

OneTouch Select® Plus test strips (test with OneTouch Select® Plus glucose meter)

Objectives:

  1. Assess Lay User and Health Care Professional (HCP) fingertip test results obtained on OneTouch Select® Plus BGMS compared to a validated method (YSI 2300 glucose analyzer results), according to International Standards Organization( ISO) 15197:2003(E) section 8.0 and ISO 15197:2013(E)
  2. Lay User System Use evaluation.
  3. Assess the effectiveness of the instructions for use of OneTouch Select® Plus BGMS (Owner's booklet) and insert of test strips for the lay user.

Comparator(control) Product:

YSI 2300 glucose analyser

Acceptance Criteria:

User Performance of the OneTouch Select® Plus Blood Glucose Monitoring system(described as OneTouch Select Plus below) is met if the lay user and HCP results obtained with OneTouch Select Plus meet the requirement stated in section 7.4.1 of ISO () 15197:2003(E). Further to meet the requirements of ISO 15197:2013(E) , the lay user results obtained with OneTouch Select Plus should meet the requirements stated in section 8.2 of ISO 15197:2013(E). The effectiveness of instructions for use is met , if for each item on the Instructions for Use Questionnaire, the 90% lower confidence limit (90% LCL) for the correct response rate is equal to or greater than 70%.

Study Design and subject population:

This study is an open, non-randomized clinical evaluation and will be conducted at a minimum of 2 sites in China. At least 240 evaluable diabetic subjects who meet the enrolment criteria will participate in this evaluation.

Study procedures:

  1. Each potential Subject (or legally authorized representative) reads and signs the Informed Consent Form, and receives a signed copy.
  2. After completing an in-clinic familiarization session, the Subject lances a fingertip, obtains a drop of blood large enough for two meter tests, and performs a self-test using OneTouch Select Plus BGMS.
  3. Study staff immediately performs a blood glucose test from the same blood drop with a second set of OneTouch Select Plus BGMS with the same lot of test strips.
  4. Within 5 minutes of the Subject's self-lancing, study staff collects blood from the same finger puncture for hematocrit and reference plasma glucose testing (duplicate tests on the YSI 2300 performed by study staff).
Being tested
OneTouch Select® Plus Glucose Test Strips

What participants receive

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

  • OneTouch Select® Plus Glucose Test StripsDevice

What is being measured

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

  1. The accuracy of glucose results obtained from OneTouch Select Plus BGMS

    User Performance of the OneTouch Select® Plus Blood Glucose Monitoring system(described as OneTouch Select Plus below) is met if the lay user and HCP results obtained with OneTouch Select Plus meet the requirement stated in section 7.4.1 of ISO 15197:2003(E).Further to meet the requirements of ISO 15197:2013(E) , the lay user results obtained with OneTouch Select Plus should meet the requirements stated in section 8.2 of ISO 15197:2013(E).

    Measured: instantly after Glucose testing

  2. The correct response rate of Instructions for Use Questionnaire

    The effectiveness of instructions for use is met , if for each item on the Instructions for Use Questionnaire, the 90% lower confidence limit (90% LCL) for the correct response rate is equal to or greater than70%

    Measured: instantly after Glucose testing

Timeline

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

  1. First posted23 Jun 2016 (estimated)
  2. Study start31 Aug 2016
  3. Primary completion30 Nov 2016 (estimated)
  4. Study completion31 Mar 2017 (estimated)

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
Non-randomised
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02810522
Sponsor's protocol ID
LFS-201601
Status last verified
Nov 2019
First submitted
8 Jun 2016
Last updated
15 Nov 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing OneTouch Select® Plus Glucose Test Strips in people with Blood Glucose Measurement, run by Johnson & Johnson Medical, China.

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 7 inclusion and 3 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: withdrawn, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

The accuracy of glucose results obtained from OneTouch Select Plus BGMS (time frame: instantly after Glucose testing). The study lists 2 primary outcomes in all. 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 NCT02810522.

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 15 Nov 2019.

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