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

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: NCT02810522
Recruitment Status : Withdrawn
First Posted : June 23, 2016
Last Update Posted : November 15, 2019
Sponsor:
Collaborators:
Shanghai 6th People's Hospital
Shanghai East Hospital
Information provided by (Responsible Party):
Johnson & Johnson Medical, China

Brief 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. 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:

  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).

Condition or disease Intervention/treatment Phase
Blood Glucose Measurement Device: OneTouch Select® Plus Glucose Test Strips Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Registration Study to Assess User Performance of OneTouch Select® Plus Blood Glucose Monitoring System
Actual Study Start Date : August 31, 2016
Estimated Primary Completion Date : November 30, 2016
Estimated Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose




Primary Outcome Measures :
  1. 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).

  2. 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%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is at least 18 years of age.
  2. Subject has a current diagnosis of type 1 or type 2 diabetes mellitus.
  3. Subject is currently performing unassisted self-monitoring of blood glucose.
  4. Subject agrees to sign two (2) copies each of the Subject Informed Consent Form.
  5. Subject agrees to provide relevant demographic, medical history and diabetes management information and agrees to allow study staff access to medical records when necessary.
  6. Subject can read and understand Chinese.
  7. 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.

Exclusion Criteria:

  1. 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.
  2. Subject has already participated in this study.
  3. Subject is knowingly pregnant.
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Responsible Party: Johnson & Johnson Medical, China
ClinicalTrials.gov Identifier: NCT02810522    
Other Study ID Numbers: LFS-201601
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019