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

Not Applicable

Suspended

• Conditions: Healthy and Unhealthy Neonates
• Interventions: Diagnostic Test: StatStrip blood glucose meter and strips

• Registration Number: NCT04194476
• Lead Sponsor: Nova Biomedical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Study Start: 2025-01-01
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
120 neonates less than 28 days old	StatStrip blood glucose meter and strips	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.

Primary Outcome Measures

Name	Time	Method
blood glucose level measured by StatStrip blood glucose meter	6 months
plasma glucose level measured by a laboratory biochemistry analyzer	6 months

Secondary Outcome Measures

Name	Time	Method
hematocrit of the heel-stick blood	6 months

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, China