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

Nova Biomedical

Status: Suspended

Conditions: Healthy and Unhealthy Neonates

Treatments: Diagnostic Test: StatStrip blood glucose meter and strips

Study type: Interventional

Funder types: Industry

Identifiers

NCT04194476

NB15-CHI-SSG-NEO

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

120 neonates less than 28 days old

Experimental group

Description:

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.

Treatment:

Diagnostic Test: StatStrip blood glucose meter and strips