Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples

Diabetes Mellitus Clinical Trial

Official title:

Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® Blood Glucose Monitoring Systems (BGMS) in Neonates Using Capillary Blood Samples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05467345
• Other study ID #: GCA-PRO-2021-003-01
• Status: Completed
• Start date: August 24, 2022
• Est. completion date: March 14, 2023

Study information

• Verified date: July 2023
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to extend the intended use of two BGMSs to include testing of neonatal blood by Health Care Professionals in a clinical setting for the quantitative measurement of glucose levels in neonates.

Description:

This trial will evaluate the performance of both the CONTOUR NEXT BGMS and CONTOUR PLUS ELITE BGMS using blood from neonates within a hospital ward, e.g. routine/newborn nurseries, Special Care Nurseries, Neonatal Intensive Care Unit (NICU). The investigational BGMSs will be tested by a Point-of-Care operator using residual heel-stick capillary blood samples from neonates who underwent routine prescribed testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: March 14, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 27 Days

Eligibility

Inclusion Criteria:

• Residual capillary (heel-stick) blood samples from neonates (less than 28 days of age) after birth as part of prescribed testing.

• Sample blood volume must be sufficient to complete investigational testing in addition to routine prescribed clinical laboratory testing.

Exclusion Criteria:

• Samples from subjects who are = 28 days of age.

• Samples from subjects who have previously been enrolled into this study.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Contour Next and Contour Plus Elite BGMS testing of neonatal blood
The purpose of this study is to extend the intended use of two BGMSs to include testing of neonatal blood by Health Care Professionals in a clinical setting for the quantitative measurement of glucose levels in neonates.

Locations

Country	Name	City	State
United States	St. Louis Children's Hospital, Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of results from the Contour Next and Contour Plus Elite BGMSs reference values within ±12.5% of reference values	At least 95% of all blood glucose results shall fall within ±12.5% of reference values (laboratory method) for glucose concentration =100 mg/dL(5.55 mmol/L )and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations <100 mg/dL(5.55 mmol/L).	12 weeks
Primary	Number of results from the Contour Next and Contour Plus Elite BGMSs reference values within ±20% of reference values	At least 98% of values should be within ±20% of reference values (laboratory method) for glucose concentration =75 mg/dL(4.16 mmol/L) and within ±15 mg/dL(±0.83 mmol/L) at glucose concentrations < 75 mg/dL(4.16 mmol/L).	12 weeks