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

NCT05467345 | Completed Results FDA Device

• 1 other identifier: GCA-PRO-2021-003-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Number of Results From the Contour Next 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).

  1 day

• Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values

  At least 95% of values should be within ±12.5% 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).

  1 day

Interventions

Contour Next and Contour Plus Elite BGMS testing of neonatal blood DEVICE

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.

Eligibility Criteria

• Age: 0 Days - 27 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The subject population will consist of neonates from hospital wards (e.g. routine/newborn nurseries, SCN, NICU) of the clinical investigational site.

You may qualify if:

• 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.

You may not qualify if:

• Samples from subjects who are ≥ 28 days of age.
• Samples from subjects who have previously been enrolled into this study.

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (1)

St. Louis Children's Hospital, Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Jane Wallace
• Organization: Ascensia Diabetes Care

jane.wallace@ascensia.com

5748501467

Study Officials

• Dennis Dietzen, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 20, 2022
• Study Start: August 24, 2022
• Primary Completion: November 30, 2022
• Study Completion: March 14, 2023
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-01

Locations

US (1)