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.
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:
- 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)
- Lay User System Use evaluation.
- 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:
- Each potential Subject (or legally authorized representative) reads and signs the Informed Consent Form, and receives a signed copy.
- 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.
- 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.
- 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).
- Conditions
- Blood Glucose Measurement
- 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.
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
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.
- First posted23 Jun 2016 (estimated)
- Study start31 Aug 2016
- Primary completion30 Nov 2016 (estimated)
- Study completion31 Mar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Medical, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai 6th People's Hospital, Shanghai East Hospital
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registration Study to Assess User Performance of OneTouch Select® Plus Blood Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT02810522
- Acronym / sponsor ID
- LFS-201601
- Conditions
- Blood Glucose Measurement
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johnson & Johnson Medical, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai 6th People's Hospital, Shanghai East Hospital
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 30 Nov 2016 (estimated)
- Study completion
- 31 Mar 2017 (estimated)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
OneTouch Select® Plus test strips (test with OneTouch Select® Plus glucose meter)
Objectives:
- 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)
- Lay User System Use evaluation.
- 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:
- Each potential Subject (or legally authorized representative) reads and signs the Informed Consent Form, and receives a signed copy.
- 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.
- 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.
- 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OneTouch Select® Plus Glucose Test Strips | Device | – |
Primary outcome
The accuracy of glucose results obtained from OneTouch Select Plus BGMS
Time frame: instantly after Glucose testing
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 correct response rate of Instructions for Use Questionnaire
Time frame: instantly after Glucose testing
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%
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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?
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; AzTrials last refreshed its copy on 7 Nov 2026.