Artificial Intelligence Guided Personalised Medicine in Patients With Hypertension and Diabetes

NCT04769141 | Unknown

• 1 other identifier: AlexandraHosp
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus; Hypertension

Outcome Measures

Primary Outcomes (1)

• Medication dosing optimization

  • 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.

  3 years

Secondary Outcomes (1)

• (CURATE.AI) pilot deployment using prospective data

  3 years

Study Arms (2)

Hypertension patients

a prospective 4-month, cohort feasibility study will evaluate blood pressure (n=20) using the CURATE.AI platform.

Combination Product: CURATE.AI

Diabetic patients

a prospective 4-month, cohort feasibility study will evaluate glycaemic (n=20) control using the CURATE.AI platform.

Combination Product: CURATE.AI

Interventions

CURATE.AI COMBINATION_PRODUCT

CURATE.AI is one example of an artificial intelligence guided dosing decision tool. It is customized to each individual and can be applicable across many different conditions, as it is disease agnostic. This platform has already demonstrated initial success in cancer and transplant populations but yet to be applied to chronic disease patients.

Diabetic patients; Hypertension patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

20 patients with a clinically confirmed diagnosis of T2DM and 20 patients with a diagnosis of hypertension will be screened, recruited and followed up.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandra Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Amartya Mukhopadhyay

CONTACT

6772 2002; Amartya_Mukhopadhyay@nuhs.edu.sg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Division of Respiratory & Critical Care Medicine, Department of Medicine, National University Hospital

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 24, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2023
• Last Updated: July 22, 2021

Record last verified: 2021-07