Diabetes MellitusNCT04769141
Artificial Intelligence Guided Personalised Medicine in Patients With Hypertension and Diabetes
An observational study of Diabetes Mellitus and Hypertension, run by Alexandra Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypertension
- What is being tested?
- CURATE.AI
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Jan 2023
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients (≥ 21years) with T2DM or hypertension
- Expected to be followed up in Alexandra Hospital for the next 4-months
- Signed informed consent form
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Artificial intelligence (CURATE.AI) pilot deployment using prospective data in patients with hypertension and type 2 diabetes mellitus.
- 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.
- Conditions
- Diabetes Mellitus, Hypertension
- Being tested
- CURATE.AI
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CURATE.AICombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Hypertension patients | a prospective 4-month, cohort feasibility study will evaluate blood pressure (n=20) using the CURATE.AI platform. Receives: Combination Product: CURATE.AI | |
| Diabetic patients | a prospective 4-month, cohort feasibility study will evaluate glycaemic (n=20) control using the CURATE.AI platform. Receives: Combination Product: CURATE.AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
(CURATE.AI) pilot deployment using prospective data
- Artificial intelligence (CURATE.AI) for behavioural assessment and compliance prediction to disease management programme in patients with hypertension and type 2 diabetes mellitus.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study startAug 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Alexandra Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amartya Mukhopadhyay, Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769141
- Sponsor's protocol ID
- AlexandraHosp
- Status last verified
- Jul 2021
- First submitted
- 22 Feb 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Guided Personalised Medicine in Patients With Hypertension and Diabetes
- ClinicalTrials.gov ID
- NCT04769141
- Acronym / sponsor ID
- AlexandraHosp
- Conditions
- Diabetes Mellitus, Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexandra HospitalUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Artificial intelligence (CURATE.AI) pilot deployment using prospective data in patients with hypertension and type 2 diabetes mellitus.
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertension patients | – | Combination Product: CURATE.AIa prospective 4-month, cohort feasibility study will evaluate blood pressure (n=20) using the CURATE.AI platform. |
| Diabetic patients | – | Combination Product: CURATE.AIa prospective 4-month, cohort feasibility study will evaluate glycaemic (n=20) control using the CURATE.AI platform. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adult patients (≥ 21years) with T2DM or hypertension
- Expected to be followed up in Alexandra Hospital for the next 4-months
- Signed informed consent form
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CURATE.AICURATE.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. | Combination product | Diabetic patients, Hypertension patients |
Primary outcome
Medication dosing optimization
Time frame: 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.
1 secondary outcome
(CURATE.AI) pilot deployment using prospective data
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Hypertension, run by Alexandra Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amartya Mukhopadhyay (6772 2002, Amartya_Mukhopadhyay@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication dosing optimization (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.