NCT06052371

Brief Summary

The goal of this performance evaluation is to compare the blood glucose results obtained using the VerioVue Blood Glucose Monitoring system (BGMS) with those obtained from a validated comparator method (iSTAT 1 Analyser) using blood obtained from neonates. The main question it aims to answer is: •How accurate is the VerioVue BGMS when compared to a product that has already been confirmed as accurate (iSTAT 1 Analyser) when hospital staff test blood taken from neonates on these instruments? Participants (neonates) will have a small amount of blood taken from a heel prick (performed by a HCP for medical purposes) or from an existing arterial line.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

September 18, 2023

Last Update Submit

December 20, 2023

Conditions

Diabetes Mellitus

Keywords

Neonate

Outcome Measures

Primary Outcomes (1)

  • Performance evaluation: blood glucose monitoring system accuracy: BGMS vs reference instrument

    Performance Evaluation to compare the VerioVue BGMS blood glucose results to results obtained using the iSTAT 1 Analyser, a validated comparator method.

    1 hour

Study Arms (1)

Neonates

Newborn babies who are 28 days old or less with a corrected gestational age of at least 34 weeks and a weight of at least 1700g or more at the time of participation. They will be recruited from hospital neonatal units or wards.

Device: VerioVue (Enhancements) blood glucose monitoring system

Interventions

VerioVue (Enhancements) blood glucose monitoring systemDEVICE

VerioVue meter with expanded haematocrit range

Also known as: OneTouch VerioVue blood glucose monitoring system
Neonates

Eligibility Criteria

Age0 Days - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates will be enrolled into the study from NHS hospital neonatal units and wards.

You may qualify if:

  • Age - Newborn babies, 28 days old or less with a corrected gestational age of at least 34 weeks and a weight of at least 1700g or more at the time of participation.
  • Informed Consent - Study participants parents must read the Parental Participant Information Sheet and sign the Parental Informed Consent Form
  • Study participants parent agrees to provide information related to demographics, prescription medication, dietary supplements, and results from other physician ordered testing e.g., Bilirubin (total, conjugated, and unconjugated) where available.
  • Study participants parent agrees to allow study staff access to medical records where necessary.
  • Study participants parents agree to all aspects of the study process, including where applicable arterial blood draw from an existing arterial line or a heel prick performed by an HCP for medical purposes.

You may not qualify if:

  • Age- Newborn more than 28 days old.
  • Study participants with a gestational age of less than 34 weeks at the time of participation.
  • Study participants with a gestational weight of less than 1700g
  • Current positive test result for Covid-19.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Whipps Cross University Hospital (Barts Health NHS Trust)

London, E1 1FR,, United Kingdom

Location

Queens Hospital Romford (BHRUT)

London, RM7 0AG, United Kingdom

Location

The Royal Oldham Hospital (Northern Care Alliance NHS Foundation Trust)

Manchester, OL1 2JH, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nicola Zammitt, MBCHB

    Edinburgh Centre for Endocrinology and Diabetes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 25, 2023

Study Start

October 16, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)