Project VerioVue Enhancements - Neonate Study

ABSTRACT

ConditionDiabetes Mellitus

InterventionDevice VerioVue (Enhancements) blood glucose monitoring system

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

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.