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

Sponsor

Nova Biomedical (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04194476

Collaborator

(none)

120

Enrollment

Location

Arm

Anticipated Duration (Months)

60.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy and Unhealthy Neonates	Diagnostic Test: StatStrip blood glucose meter and strips	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

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

hematocrit of the heel-stick blood [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days to 28 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai General Hospital	Shanghai		China	200080

Sponsors and Collaborators

Nova Biomedical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nova Biomedical

ClinicalTrials.gov Identifier:

NCT04194476

Other Study ID Numbers:

NB15-CHI-SSG-NEO

First Posted:

Dec 11, 2019

Last Update Posted:

Dec 3, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Nova Biomedical

neonates

glucose

Study Results

No Results Posted as of Dec 3, 2021