Blood Glucose MonitoringLSPPGNCT06717646
Using Laser Spatiotemporal Photoplethysmogram and Computational Method for Management of Chronic Disorders.
An observational study of Blood Glucose Monitoring and Blood Pressure Measurement, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
This investigational study is carried out to find out if a smartwatch monitor worn on the wrist that acts like a blood pressure monitor, will be able to replace the traditional blood pressure measurements using the traditional cuff that is wrapped around your arm. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Blood Glucose Monitoring, Blood Pressure Measurement
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Apr 2024to Jun 2025
- 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: Patients from National Heart Centre Singapore
Who may be able to join
- Above 21 years of age
- Sufficient language skills in English, Chinese, Malay or Tamil
- Provided informed consent
Who cannot join
- Skin sensitivity to adhesives
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, 169609
Alex Tan Weixian, MBBS, +65 67048945, alex.tan.w@singhealth.com.sg
Alex Tan Weixian, MBBS
About this study
Official title: Laser Spatiotemporal Photoplethysmogram and Computational Method for Extended Chronic Cardiometabolic Therapeutic Care
This investigational study is carried out to find out if a smartwatch monitor worn on the wrist that acts like a blood pressure monitor, will be able to replace the traditional blood pressure measurements using the traditional cuff that is wrapped around your arm.
Read the detailed description
NHC inpatients (Group A) Patients will be required to put on the LSPPG wearable sensor to take measurement once a day, starting from the day of recruitment till day of discharge. 3 ECG electrodes with cable linking to the LSPPG sensor wearable will also be attached on the chest. This helps to capture ECG rhythm at the same time. Study team member will assist the patient to take daily measurement.
NHC Outpatients scheduled for 24-Hour ABP monitoring (Group B) Patients will wear the LSPPG wearable sensor whilst wearing the 24-hour ambulatory blood pressure monitor. 3 ECG electrodes with cable linking to the LSPPG sensor wearable will also be attached on the chest. This helps to capture ECG rhythm at the same time. Readings will be obtained on an hourly basis during the duration of wearing the ambulatory blood pressure machine (clinical grade device).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient | Patients warded under National Heart Centre Singapore | |
| Outpatients | Patients scheduled for 24-hour Ambulatory Blood Pressure Monitoring at National Heart Centre Singapore |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparable results to traditional methods
Perform comparably to the 24-hour ambulatory blood pressure meters and continuous glucose monitors (CGM) to establish hypertension and blood glucose changes
Measured: 24 Hours
Improve efficiency
Provide real time feedback to patients and healthcare providers to individualize hypertension / hyperglycemic treatment
Measured: 24 Hours
Lifestyle Improvement
Consider patient lifestyle changes and reduce medication burden, especially in the elderly when blood pressure control is optimal.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start11 Apr 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose MonitoringStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717646
- Sponsor's protocol ID
- 2021/2724
- Acronym
- LSPPG
- Status last verified
- Mar 2024
- First submitted
- 18 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Spatiotemporal Photoplethysmogram and Computational Method for Extended Chronic Cardiometabolic Therapeutic Care
- ClinicalTrials.gov ID
- NCT06717646
- Acronym / sponsor ID
- LSPPG / 2021/2724
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 5 Dec 2024 (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.
This investigational study is carried out to find out if a smartwatch monitor worn on the wrist that acts like a blood pressure monitor, will be able to replace the traditional blood pressure measurements using the traditional cuff that is wrapped around your arm.
Detailed description
NHC inpatients (Group A) Patients will be required to put on the LSPPG wearable sensor to take measurement once a day, starting from the day of recruitment till day of discharge. 3 ECG electrodes with cable linking to the LSPPG sensor wearable will also be attached on the chest. This helps to capture ECG rhythm at the same time. Study team member will assist the patient to take daily measurement.
NHC Outpatients scheduled for 24-Hour ABP monitoring (Group B) Patients will wear the LSPPG wearable sensor whilst wearing the 24-hour ambulatory blood pressure monitor. 3 ECG electrodes with cable linking to the LSPPG sensor wearable will also be attached on the chest. This helps to capture ECG rhythm at the same time. Readings will be obtained on an hourly basis during the duration of wearing the ambulatory blood pressure machine (clinical grade device).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient | – | –Patients warded under National Heart Centre Singapore |
| Outpatients | – | –Patients scheduled for 24-hour Ambulatory Blood Pressure Monitoring at National Heart Centre Singapore |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from National Heart Centre Singapore
Key inclusion criteria (3 listed)
- Above 21 years of age
- Sufficient language skills in English, Chinese, Malay or Tamil
- Provided informed consent
Key exclusion criteria (1 listed)
- Skin sensitivity to adhesives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparable results to traditional methods
Time frame: 24 Hours
Perform comparably to the 24-hour ambulatory blood pressure meters and continuous glucose monitors (CGM) to establish hypertension and blood glucose changes
Improve efficiency
Time frame: 24 Hours
Provide real time feedback to patients and healthcare providers to individualize hypertension / hyperglycemic treatment
Lifestyle Improvement
Time frame: 24 Hours
Consider patient lifestyle changes and reduce medication burden, especially in the elderly when blood pressure control is optimal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Glucose Monitoring and Blood Pressure Measurement, run by National Heart Centre Singapore at 1 site in Singapore.
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 1 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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparable results to traditional methods (time frame: 24 Hours). The study lists 3 primary outcomes in all. 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 5 Dec 2024.