OneTouch® Verio™Pro+ Blood Glucose Monitoring System Clinical Accuracy Study in China

NCT ID: NCT01795625

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

301 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The evaluation will determine professional clinical accuracy comparing the OneTouch® Verio™Pro+ blood glucose results with the YSI 2300 analyzer. "Professional Clinical Accuracy" is defined as accuracy of the system when used by a trained healthcare professional.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Glucose Measurement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject is at least 18 years of age.
* Subject has been diagnosed with diabetes mellitus (type 1 or type 2 diabetes)
* Subject agrees to sign two (2) copies each of the Subject Informed Consent Form and to follow the procedures of the study.
* Subject agrees to allow the HCP to perform finger stick for blood glucose test by the meter and the YSI instrument. Up to one retry of finger stick will be needed in the event of insufficient blood collected or test failure.
* Subject agrees to allow the HCP to perform venous puncture for blood glucose test by the meter and the YSI instrument, and for haematocrit (HCT) test. Up to one retry of venous puncture will be needed in the event of insufficient blood collected or test failure.
* Subject agrees to provide demographic and medical history information and give access to medical records where appropriate.

Exclusion Criteria

* 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 known pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johnson & Johnson Medical, China

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yongde Peng, Professor

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Fengling Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiaotong University, medical school affiliated Third People's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai First People's Hospital

Shanghai, , China

Site Status

Shanghai Jiaotong University, medical school affiliated Third People's Hospital

Shanghai, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LFS-201201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The CGM-OGTT Glycemic Homeostasis Study
NCT07288372 NOT_YET_RECRUITING