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Project VerioVue Enhancements - Neonate Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06052371
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : November 3, 2023
Sponsor:
Information provided by (Responsible Party):
LifeScan Scotland Ltd

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.


Condition or disease Intervention/treatment
Diabetes Mellitus Device: VerioVue (Enhancements) blood glucose monitoring system

Detailed Description:
UK NHS Hospital sites (between 1 and 3 sites) will be used to collect a minimum of 200 evaluable blood samples from neonates meeting the inclusion criteria. Consent will be taken from the neonates parent prior to participation in the study. They will consent to one or two blood samples to be taken from their child. If the participant meets the enrolment criteria then demographics and prescription medication (including dietary supplements) information will be collected. A small volume of blood (max 150µl) will be collected from an existing arterial line or from a heel prick that is being performed for medical purposes. This blood will then be applied to six investigational One Touch VerioVue meters (with expanded haematocrit range of 20-65%) fitted with OneTouch Verio test strips and the blood glucose meter readings recorded. Three different lots of test strips will used in rotation across the study. Within 5 minutes of the last meter test, NHS study staff will use blood from the same sample and perform a test on the iSTAT 1 Analyser to obtain blood glucose, haematocrit and oxygen levels of the sample. No treatment decisions will be made based on the blood glucose results obtained for this study. The study documentation will be reviewed by LifeScan monitors for completeness and accuracy and the results entered into a validated database. The data will be extracted and statistically analysed to determine the accuracy of the blood glucose results obtained using the OneTouch VerioVue BGMS when compared to the blood glucose results obtained on the iSTAT 1 Analyser.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: VerioVue Enhancements Regulatory Clinical Evaluation - Professional Comparison to Validated Method: Neonate Study
Actual Study Start Date : October 16, 2023
Estimated Primary Completion Date : January 30, 2024
Estimated Study Completion Date : February 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Glucose

Group/Cohort Intervention/treatment
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
VerioVue meter with expanded haematocrit range
Other Name: OneTouch VerioVue blood glucose monitoring system




Primary Outcome Measures :
  1. Performance evaluation: blood glucose monitoring system accuracy: BGMS vs reference instrument [ Time Frame: 1 hour ]
    Performance Evaluation to compare the VerioVue BGMS blood glucose results to results obtained using the iSTAT 1 Analyser, a validated comparator method.



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Days to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Neonates will be enrolled into the study from NHS hospital neonatal units and wards.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06052371


Contacts
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Contact: Ayaz Alam +44 (0) 7515412196 aalam11@lifescan.com
Contact: Barry Irvine +44 (0)7990 827 341 birvine1@lifescan.com

Locations
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United Kingdom
Whipps Cross University Hospital (Barts Health NHS Trust) Recruiting
London, United Kingdom, E1 1FR,
Contact: Hafiza Khatun       hafiza.khatun@nhs.net   
Queens Hospital Romford (BHRUT) Not yet recruiting
London, United Kingdom, RM7 0AG
Contact: Heidi Chandler       heidi.chandler@nhs.net   
The Royal Oldham Hospital (Northern Care Alliance NHS Foundation Trust) Recruiting
Manchester, United Kingdom, OL1 2JH
Contact: Grainne O'Connor       grainne.oconnor@nca.nhs.uk   
Sponsors and Collaborators
LifeScan Scotland Ltd
Investigators
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Principal Investigator: Nicola Zammitt, MBCHB Edinburgh Centre for Endocrinology and Diabetes
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Responsible Party: LifeScan Scotland Ltd
ClinicalTrials.gov Identifier: NCT06052371    
Other Study ID Numbers: FILE-PROT-005443
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: November 3, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LifeScan Scotland Ltd:
Neonate