Performance Study of Nova StatStrip® Blood Glucose Monitoring Test System on Neonatal Capillary Blood

NCT ID: NCT04194476

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-03-30

Brief Summary

This study is to determine the validity of Nova StatStrip® blood glucose monitoring test system including the Nova StatStrip® glucose hospital meter and test strips in measuring Chinese neonatal capillary blood glucose levels by evaluating how the results compare to those obtained from laboratory hexokinase method. The study results will be the basis for the regulatory submission and registration of the Nova StatStrip® glucose hospital meter and test strips in testing the neonatal capillary whole blood specimens to the China Food and Drug Administration (CFDA).

Good clinical practice indicates that the performance of a point-of-care glucose monitoring test system be validated before clinical use. It is therefore important to perform a method comparison study to determine how the results obtained from a type of glucose monitoring test system compare to those from a laboratory hexokinase method.

Conditions

Healthy and Unhealthy Neonates

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

120 neonates less than 28 days old

Each neonate will be tested for blood glucose level twice on the same heel stick site using two glucose meters. additional 200-300 ul blood will be collected and centrifuged. Plasma will be tested blood glucose in the lab analyzer in the clinical laboratory.

Group Type: EXPERIMENTAL

StatStrip blood glucose meter and strips

Intervention Type: DIAGNOSTIC_TEST

We'll use a drop of heel-stick blood to test blood glucose on the glucose meter. About 200-300 ul of blood from the same stick site will be collected, centrifuged to get plasma for testing of glucose level in a laboratory biochemistry analyzer.

Interventions

StatStrip blood glucose meter and strips

We'll use a drop of heel-stick blood to test blood glucose on the glucose meter. About 200-300 ul of blood from the same stick site will be collected, centrifuged to get plasma for testing of glucose level in a laboratory biochemistry analyzer.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Subject is within 28 days after birth.
• The legal representative of the Subject agrees to sign two copies of the Informed Consent Form.
• The Subject's capillary whole blood needs to be drawn via heel stick for routine clinical laboratory testing according to the prescription.
• The legal representative of the Subject agrees that the Subject provides 300 µL capillary whole blood for glucose and haematocrit testing in addition to routine clinical laboratory testing.

Exclusion Criteria

• Subject/legal representative 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.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Biomedical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai General Hospital

Shanghai, , China

Countries

China

Other Identifiers

NB15-CHI-SSG-NEO

Identifier Type: -

Identifier Source: org_study_id