Clinical trial NCT04814680: Machine-Learning Algorithm for Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate From Digital Retinal Images
Keywords: - Machine learning; retinal images; blood pressure; glycated haemoglobin; glomerular filtration rate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2021-03-24
Enrollment: 301
Sex: ALL
Minimum age (years): 35
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants have to be more than 35 years, able to provide written consent and meet the following inclusion criteria:

* 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)

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: up to 66 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Research Site
city: Nairobi
country: Kenya
facility: Research Site
Study officials:
References: