- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04769141
Artificial Intelligence Guided Personalised Medicine in Patients With Hypertension and Diabetes
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Amartya Mukhopadhyay
- Telefonnummer: 6772 2002
- E-mail: Amartya_Mukhopadhyay@nuhs.edu.sg
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Hypertension patients
a prospective 4-month, cohort feasibility study will evaluate blood pressure (n=20) using the CURATE.AI platform.
|
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
a prospective 4-month, cohort feasibility study will evaluate glycaemic (n=20) control using the CURATE.AI platform.
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Medication dosing optimization
Tidsramme: 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.
|
3 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
(CURATE.AI) pilot deployment using prospective data
Tidsramme: 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.
|
3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AlexandraHosp
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Forhøjet blodtryk
-
BayerAfsluttet
-
National Taiwan University Hospital Hsin-Chu BranchRekrutteringHypertension, essentiel | Hypertension, maskeretTaiwan
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldAfsluttetIdiopatisk pulmonal arteriel hypertension | Kronisk tromboembolisk pulmonal hypertensionDet Forenede Kongerige
-
University of Kansas Medical CenterRekrutteringPulmonal arteriel hypertension | Pulmonal hypertension | Kronisk tromboembolisk pulmonal hypertension | Pulmonal hypertension på grund af venstre hjertesygdom | Pulmonal hypertension, primær, 4 | Pulmonal hypertension, primær, 2 | Pulmonal hypertension, primær, 3 | Pulmonal hypertension, primær | Pulmonal...Forenede Stater
-
University of South FloridaTrukket tilbagePulmonal arteriel hypertension | Familiær primær pulmonal hypertension | Idiopatisk pulmonal arteriel hypertension | Primær pulmonal hypertensionForenede Stater
-
Papworth Hospital NHS Foundation TrustMerck Sharp & Dohme LLCAfsluttet
-
Centre Chirurgical Marie LannelongueUkendtKronisk trombo-embolisk pulmonal hypertension og pulmonal arteriel hypertensionFrankrig
-
Heidelberg UniversityMerck Sharp & Dohme LLCRekrutteringKronisk tromboembolisk pulmonal hypertension | Primær pulmonal arteriel hypertensionTyskland
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Aktiv, ikke rekrutterendeWhite Coat Hypertension | Hypertension, essentielForenede Stater
-
Vanderbilt University Medical CenterJohns Hopkins UniversityAfsluttetPulmonal arteriel hypertension | Idiopatisk pulmonal arteriel hypertension | Associeret pulmonal arteriel hypertension | Arvelig pulmonal arteriel hypertensionForenede Stater
Kliniske forsøg med CURATE.AI
-
Alexandra HospitalNational University Hospital, SingaporeRekruttering
-
National University Hospital, SingaporeNational University, Singapore; The N.1 Institute for Health (N.1)Rekruttering
-
National University Hospital, SingaporeThe N.1 Institute for Health (N.1)Rekruttering
-
National University Hospital, SingaporeNatera, Inc.; The N.1 Institute for Health (N.1)Rekruttering
-
National University Hospital, SingaporeThe N.1 Institute for Health (N.1); Cancer Science Institute of SingaporeIkke rekrutterer endnuBrystkræft | Solid tumor | Gastrointestinal kræftSingapore
-
National University Hospital, SingaporeNational University of SingaporeRekruttering