Artificial Intelligence Guided Personalised Medicine in Patients With Hypertension and Diabetes

• Conditions: Hypertension; Diabetes Mellitus
• Interventions: Combination Product: CURATE.AI

• Registration Number: NCT04769141
• Lead Sponsor: Alexandra Hospital

Brief Summary

Hypertension and diabetes are chronic diseases that require long-term management and disease control is often sub-optimal, leading to complications which place additional burden on patients and the healthcare system.

This study aims to address factors such as gender, ethnicity and specific genetics that are not routinely considered during drug dosing but account for considerable variations in drug responses by tailoring the treatment to individual patient using CURATE.AI. CURATE.AI is an artificial intelligence guided dosing decision tool and can be applicable across many different conditions, as it is disease agnostic. This platform had demonstrated initial success in cancer and transplant populations but has yet to be applied to chronic disease patients.

The aim of this study is demonstrate that artificial intelligence guided treatment in chronic disease of hypertension and type 2 diabetes mellitus will yield actionable medication dosing optimization.

Detailed Description

The aim of this study is demonstrate that artificial intelligence guided treatment in chronic disease of hypertension and type 2 diabetes mellitus will yield actionable medication dosing optimization.

Study Objectives

1. Artificial intelligence (CURATE.AI) pilot deployment using prospective data in patients with hypertension and type 2 diabetes mellitus.

2. Artificial intelligence (CURATE.AI) for behavioural assessment and compliance prediction to disease management programme in patients with hypertension and type 2 diabetes mellitus.

Methods and Analysis Design and setting

This prospective cohort feasibility study will evaluate the blood pressure (n=20) and glycaemic (n=20) control of patients using the CURATE.AI platform. Participants will be recruited for a period of 4 months from the day of baseline visit and followed up for up to 4 clinic visits.

Recruitment Participants will be recruited from the study site, Alexandra Hospital, Singapore during their routine clinic visits. The doctor will identify individuals who meet the inclusion criteria and the research team will share further details regarding the study including the inclusion/ exclusion criteria that is presented below.

Interested individuals who meet the eligibility criteria will be required to sign the Informed Consent From prior to any study activity and a baseline visit will be scheduled.

Inclusion criteria

* Adult patients (≥ 21years) with T2DM or hypertension

* Expected to be followed up in Alexandra Hospital for the next 4-months

* Signed informed consent form

Exclusion criteria

* Patients with cognitive impairment

* Patients with active cancer undergoing chemotherapy

* Patients on haemodialysis or peritoneal dialysis (which can cause rapid fluctuation of BP and blood sugar, respectively)

* Pregnant patients

* Patients whose medications for T2DM and hypertension are changed simultaneously during the first clinic visit

* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.

Study procedures The CURATE.AI correlation requires three data-points to calculate the initial drug dose. Ongoing readings provide further data-points for dose modulation.

Once a patient with hypertension or T2DM is identified and consented, a BP or blood sugar will be recorded (1st data-point) and baseline assessment performed

Following any change of hypertension (or T2DM) medications, a 24-hour ambulatory BP (or continuous glucose monitoring) will be done during the 7-15 days after baseline visit (data-point 2 or data-point 3 if retrospective data is available). Data from these recordings will be used to titrate medications, if necessary, in the follow-up visits.

One month after baseline the patient will return to the clinic for follow-up (data-point 3 or data point 4 if retrospective data is available) and dose adjustment, if required.

Dosing decisions at this point and going forward will be made by CURATE.AI and verified by the clinician. If dose adjustment is required, then the patient will repeat the home monitoring (24-hour ambulatory BP or continuous glucose monitoring). If dose adjustment is not needed the patient will undertake no home monitoring. Either way each patient will return one month later for clinic follow-up (clinic visit 2). This monthly cycle is repeated until each patient has reached 4-months follow-up.

At the final clinic visit (4-months after baseline) the baseline assessments are repeated. At this point patients will also be approached to complete a patient experience survey.

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-24
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22
• Study Start: 2021-08
• Primary Completion: 2021-12
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult patients (≥ 21years) with T2DM or hypertension
• Expected to be followed up in Alexandra Hospital for the next 4-months
• Signed informed consent form

Exclusion Criteria

• Patients with cognitive impairment
• Patients with active cancer undergoing chemotherapy
• Patients on hemodialysis or peritoneal dialysis (which can cause rapid fluctuation of BP and blood sugar, respectively)
• Pregnant patients
• Patients whose medications for T2DM and hypertension are changed simultaneously during the first clinic visit
• Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypertension patients	CURATE.AI	a prospective 4-month, cohort feasibility study will evaluate blood pressure (n=20) using the CURATE.AI platform.
Diabetic patients	CURATE.AI	a prospective 4-month, cohort feasibility study will evaluate glycaemic (n=20) control using the CURATE.AI platform.

Primary Outcome Measures

Name	Time	Method
Medication dosing optimization	3 years	• Artificial intelligence guided treatment in chronic disease of hypertension and type 2 diabetes mellitus will yield actionable medication dosing optimization and to demonstrate technical development of artificial intelligence platform (CURATE.AI) using retrospective data in patients with hypertension and type 2 diabetes mellitus.

Secondary Outcome Measures

Name	Time	Method
(CURATE.AI) pilot deployment using prospective data	3 years	• Artificial intelligence (CURATE.AI) for behavioural assessment and compliance prediction to disease management programme in patients with hypertension and type 2 diabetes mellitus.