1.
ClinicalTrials.gov; 02/11/2023; TrialID: NCT06121856
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06121856
ABSTRACT
Condition:
Diabetes MellitusIntervention:
Device: VerioVue Enhancements BGMSPrimary outcome:
Performance evaluation: blood glucose monitoring system accuracy: BGMS vs reference instrument using arterial bloodCriteria:
Inclusion Criteria:
Age - The potential Subject is at least 16 years old. Language - Subject reads and
understands English. Informed Consent - The potential subject must read the Participant
Information Sheet and sign the Informed Consent Form.
Subject agrees to provide relevant demographic, medical history, and prescription
medication information.
The subject agrees to allow study staff access to medical records where necessary.
The Subject agrees to all aspects of the study process, including arterial blood draws
performed by an HCP.
Exclusion Criteria:
Age - Subject is under 16 years old. Current Covid-19 positive test result.
2.
ClinicalTrials.gov; 18/09/2023; TrialID: NCT06052371
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06052371
ABSTRACT
Condition:
Diabetes MellitusIntervention:
Device: VerioVue (Enhancements) blood glucose monitoring systemPrimary outcome:
Performance evaluation: blood glucose monitoring system accuracy: BGMS vs reference instrumentCriteria:
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.