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

NCT ID: NCT02810522

Last Updated: 2019-11-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-03-31

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).

Conditions

Blood Glucose Measurement

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

OneTouch Select® Plus Glucose Test Strips

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai East Hospital

OTHER

Sponsor Role: collaborator

Johnson & Johnson Medical, China

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

LFS-201601

Identifier Type: -

Identifier Source: org_study_id