Status:
COMPLETED
Machine-Learning Algorithm for Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate From Digital Retinal Images
Eligibility:
All Genders
35-130 years
Brief Summary
This is a non-interventional pilot study with the following objectives: * Establish scalable methodology for collection of retinal images, blood pressure (BP) and laboratory-based assessments * Compa...
Eligibility Criteria
Inclusion
- Participant must be ≥ 35 years of age, at the time of signing the informed consent.
- With or without DM (at least 50% of participants will have an HbA1c ≥ 6.5%\* and/or a known diagnosis of DM)
- Male or female (at least 40% of participants must be male, and at least 40% must be female)
- Capable of giving signed informed consent as described in Appendix A
Exclusion
- As judged by the investigator, any evidence of a medical condition which in the investigator's opinion makes it undesirable for the participant to participate in the study for example, but not limited to, if a participant is critically unwell or requiring ongoing emergency treatment
- Any known eye condition that may preclude clear imaging of the retina for example; cataracts
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
- Previous enrolment in the present study with the exception of roll-in participants who may be re-screened and re-enrolled.
Key Trial Info
Start Date :
November 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT04814680
Start Date
November 8 2021
End Date
February 10 2022
Last Update
January 4 2023
Active Locations (2)
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1
Research Site
Nairobi, Kenya, 00100
2
Research Site
Nairobi, Kenya, 00200