NCT04194476

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Nova Biomedical · Industry
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2019-12-11
• Last updated: 2024-04-11

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study