NCT04814680CompletedNot Applicable
A Non-Interventional Pilot Study to Evaluate A Machine-Learning Algorithm for Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate From Digital Retinal Images
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 301
- Locations
- 1
- Primary Endpoint
- To assess successful use of methodology for retinal image acquisition, BP (ABPM or manual), HbA1C (laboratory based or point of care test) and e-GFR measurement.
Study Overview
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
- Compare the results of a machine-learning algorithm in predicting BP, glycated haemoglobin (HbA1c) and estimated glomerular filtration rate (eGFR) from digital retinal images with clinical and laboratory-based measures
- Determine the required sample size needed to support a future study to fully validate the machine-learning algorithm
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 35 Years to 130 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
To assess successful use of methodology for retinal image acquisition, BP (ABPM or manual), HbA1C (laboratory based or point of care test) and e-GFR measurement.
Time Frame: up to 66 day
Proportion of participants with completed study procedures and interpretable results including both retinal images, systolic and diastolic BP (ABPM or manual), HbA1c (laboratory based or point of care test) and eGFR at Visit 1
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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