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

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

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 Overview

• Status: Completed
• Conditions: Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate From Digital Retinal Images

• Study Type: Observational
• Enrollment (Actual): 301

Contacts and Locations

Study Locations

• Kenya
  • Nairobi, Kenya, 00200
    • Research Site
  • Nairobi, Kenya, 00100
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	up to 66 day

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Iqvia Pty Ltd

Publications and helpful links

Helpful Links

• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): February 10, 2022
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: - Machine learning; retinal images; blood pressure; glycated haemoglobin; glomerular filtration rate
• Other Study ID Numbers: D9080C00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No