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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Page 1 of 1 (2 locations)

1

Research Site

Nairobi, Kenya, 00100

2

Research Site

Nairobi, Kenya, 00200

Machine-Learning Algorithm for Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate | DecenTrialz