Blood Glucose, HighNCT05504096
Calibration and Evaluation of Non-Invasive Wireless Blood Glucose Monitoring
A study testing Actxa BGM Tracker (GLO2) and SVT In-Ear Prototype (IEP) in people with Blood Glucose, High and Blood Glucose, Low, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Wrist-worn wearables are used for fitness and health monitoring. This global expansion of wearable technology opens up opportunities for the diagnosis and management of chronic conditions. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, High, Blood Glucose, Low
- What is being tested?
- Actxa BGM Tracker (GLO2) and SVT In-Ear Prototype (IEP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Oct 2021to 18 Feb 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 21 years and above
- Are able to walk to, take public transport to or drive to the testing site independently
- Able to understand written and spoken English
Who cannot join
- Have difficulty in giving informed consent
- Have a pacemaker
- Are diagnosed with hypertension
- Are on anti-hypertensive drugs
- Are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Wrist-worn wearables are used for fitness and health monitoring. This global expansion of wearable technology opens up opportunities for the diagnosis and management of chronic conditions.
Diabetic patients have a two to three-fold higher risk of developing cardiovascular disease and that cardiovascular diseases accounted for 29.2.% of all deaths in Singapore. The wearable device is a promising avenue that allows for continuous monitoring of the large population of patients. Its ubiquitous and easy to use nature is an added advantage for its implementation.
In this study, the investigators aim to leverage existing photoplethysmography (PPG) technology, together with artificial intelligence, to accurately monitor blood glucose levels in a continuous and non-invasive manner. A simple non-invasive tool to monitor blood glucose will be developed, and alerts will be issued when the blood glucose levels fall in the unhealthy range. A standard glucometer will be used to calibrate and validate PPG measurements of blood glucose. This study aims to recruit 500 participants from KK Women's and Children's Hospital.
Read the detailed description
Wrist-worn wearables are currently being used for fitness and health monitoring. The global expansion of wearable technology combined with smartphones access creates new questions and opportunities in the diagnosis and management of chronic conditions.
High-end consumer wearables have integrated green light reflection photoplethysmography (PPG) sensors into their products. A PPG is an optically obtained plethysmogram that can be used to detect blood volume changes within mascrovasculature.
Smartphones, smartwatches and heart rate tracking devices are the most commonly used devices to feature PPG. In a published literature assessing smartphone apps using PPG for heart rate monitoring, it has found that these devices are reasonably accurate, with correlation coefficients > 0.93 and mean absolute percentage errors ranging from 3.3% to 6.2%. Although PPG sensors were initially only designed to track heart rate, there has been a push to use these with algorithms in the detection of arrhythmias such as AF, and other fields.
Diabetic patients have a two to three-fold higher risk of developing cardiovascular disease, and that cardiovascular diseases accounted for 29.2% of all deaths in Singapore. Wearable devices are ubiquitous, easy to use, and may allow for screening and further monitoring of a large population of patients.
This research proposes to leverage PPG technology, together with artificial intelligence, and incorporate this into affordable wearable lifestyle devices, wrist-worn and in-ear, to accurately monitor continuously and non-invasively glucose levels in humans. A simple non-invasive tool to monitor blood glucose will be developed, and alerts will be issued when the blood glucose level falls in the unhealthy range. The standard glucometer will be used to calibrate and validate the PPG measurements of blood glucose. This study targets to recruit and measure the blood glucose of 500 participants from KK Women's and Children's Hospital.
The primary aims of this study are: (1) Calibrate and validate PPG measurements of blood glucose, obtained both the wrist-worn and in-ear PPG devices, against the standard glucometer; (2) To develop a risk prediction model to identify subjects with blood glucose in the unhealthy range, using both subject characteristics and important features extracted from the PPG measurements using machine learning techniques.
The secondary aim of this study is to validate that in-ear and wrist-worn wearables both provide relative accurate heart rate and heart rate interval measurements.
- Conditions
- Blood Glucose, High, Blood Glucose, Low
- Being tested
- Actxa BGM Tracker (GLO2), SVT In-Ear Prototype (IEP)
- Keywords
- Blood Glucose Monitoring, Wearable, Photoplethysmography (PPG), Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actxa BGM Tracker (GLO2)Device
Wrist-worn wearable
SVT In-Ear Prototype (IEP)Device
In-Ear wearable
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm: Healthy Participants | Other | All participants will be administered with the In-Ear and Wearable devices concurrently for 8 minutes while the application records the readings from the devices. Participants with the first glucometer reading of less than 11.1 mmol/L will be required to return one-hour post sugary drink consumption for a second reading with both devices. Receives: Device: Actxa BGM Tracker (GLO2); Device: SVT In-Ear Prototype (IEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary blood glucose level using the glucometer and PPG signal readings
Raw PPG signal readings obtained from the devices will be collected via an application on a phone. Capillary glucose reading will be obtained using a glucometer at the same sitting.
Measured: Both the PPG signals and capillary blood glucose will be collected at the same time during the visit lasting up to 2 hour per subject. A total of 500 subjects will be recruited up to 6 months
Risk prediction model of diabetes using PPG features on the wearables
This study aims to develop means for non-invasive measurement of blood glucose and to assist with the early detection of diabetes among subjects who do not exhibit any noticeable signs of the disease.
PPG data will be collected from the wearables, and the standard glucometer will be used to calibrate and validate these PPG measurements of blood glucose. The objective is to calibrate and evaluate PPG as a means for assessing and monitoring blood glucose levels.
The effects of each of the PPG variables collected will be assessed by its ability to detect an increased blood glucose level, in terms of sensitivity, specificity, and positive and negative predictive values.
A risk prediction model will be developed to identify subjects with blood glucose in the unhealthy range, using both subject characteristics and important features extracted from the PPG measurements using artificial intelligence and machine learning techniques.
Measured: The study will be completed within 6 months involving 500 subjects. Data analysis and risk prediction model will be completed up to 12 months
Secondary outcomes (1)
Validate that in-ear and wrist-worn wearables both provide relative accurate heart rate and heart rate interval measurements.
Smartwatches in the market have been shown to provide relatively accurate data as to the measurement of heart rate and this feature has been incorporated into newly developed smartwatches.
In this study, PPG data collected will be used to assess by its ability to detect heart rate and heart rate intervals, in terms of sensitivity, specificity, and positive and negative predictive values.
Measured: Subjects will be assessed at one visit study. Total duration of the study is 15mins for subjects whose capillary blood glucose is greater than or equal to 11.1mmol/L, and about 90minutes for those less than 11.1mmol/L.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start8 Oct 2021
- Primary completion18 Feb 2023
- Study completion18 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Blood Glucose, HighStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Actxa Pte Ltd
- Responsible party
- Principal investigator, Ang Seng Bin, KK Women's and Children's Hospital
- Investigators
- Seng Bin Ang, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504096
- Sponsor's protocol ID
- 2020/2968
- Status last verified
- Feb 2023
- First submitted
- 19 Nov 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kviesis-Kipge, E., Zaharans, J., Rubenis, O., & Grabovskis, A. A photoplethysmography device for multipurpose blood circulatory system assessment. In European Conference on Biomedical Optics (p. 80900W). Optical Society of America.
Monte-Moreno E. Non-invasive estimate of blood glucose and blood pressure from a photoplethysmograph by means of machine learning techniques. Artif Intell Med. 2011 Oct;53(2):127-38. doi: 10.1016/j.artmed.2011.05.001. Epub 2011 Jun 22.
PubMed 21696930Philip, L.A., Rajasekaran, K., & Smily Jeya Jothi, E. Continuous monitoring of blood glucose using photophlythesmograph signal. Proceedings of IEEE International Conference on Innovations in Electrical, Electronics, Instrumentation and Media Technology (ICEEIMT). 2017: 187-191
Hina, H. Nadeem and W. Saadeh, A Single LED Photoplethysmography-Based Noninvasive Glucose Monitoring Prototype System. 2019 IEEE International Symposium on Circuits and Systems (ISCAS). 2019; 1-5
De Ridder B, Van Rompaey B, Kampen JK, Haine S, Dilles T. Smartphone Apps Using Photoplethysmography for Heart Rate Monitoring: Meta-Analysis. JMIR Cardio. 2018 Feb 27;2(1):e4. doi: 10.2196/cardio.8802.
PubMed 31758768
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration and Evaluation of Non-Invasive Wireless Blood Glucose Monitoring
- ClinicalTrials.gov ID
- NCT05504096
- Acronym / sponsor ID
- 2020/2968
- Conditions
- Blood Glucose, High, Blood Glucose, Low
- Keywords
- Blood Glucose Monitoring, Wearable, Photoplethysmography (PPG), Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Actxa Pte Ltd
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 18 Feb 2023 (actual)
- Study completion
- 18 Feb 2023 (actual)
- First posted
- 17 Aug 2022 (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.
Wrist-worn wearables are used for fitness and health monitoring. This global expansion of wearable technology opens up opportunities for the diagnosis and management of chronic conditions.
Diabetic patients have a two to three-fold higher risk of developing cardiovascular disease and that cardiovascular diseases accounted for 29.2.% of all deaths in Singapore. The wearable device is a promising avenue that allows for continuous monitoring of the large population of patients. Its ubiquitous and easy to use nature is an added advantage for its implementation.
In this study, the investigators aim to leverage existing photoplethysmography (PPG) technology, together with artificial intelligence, to accurately monitor blood glucose levels in a continuous and non-invasive manner. A simple non-invasive tool to monitor blood glucose will be developed, and alerts will be issued when the blood glucose levels fall in the unhealthy range. A standard glucometer will be used to calibrate and validate PPG measurements of blood glucose. This study aims to recruit 500 participants from KK Women's and Children's Hospital.
Detailed description
Wrist-worn wearables are currently being used for fitness and health monitoring. The global expansion of wearable technology combined with smartphones access creates new questions and opportunities in the diagnosis and management of chronic conditions.
High-end consumer wearables have integrated green light reflection photoplethysmography (PPG) sensors into their products. A PPG is an optically obtained plethysmogram that can be used to detect blood volume changes within mascrovasculature.
Smartphones, smartwatches and heart rate tracking devices are the most commonly used devices to feature PPG. In a published literature assessing smartphone apps using PPG for heart rate monitoring, it has found that these devices are reasonably accurate, with correlation coefficients > 0.93 and mean absolute percentage errors ranging from 3.3% to 6.2%. Although PPG sensors were initially only designed to track heart rate, there has been a push to use these with algorithms in the detection of arrhythmias such as AF, and other fields.
Diabetic patients have a two to three-fold higher risk of developing cardiovascular disease, and that cardiovascular diseases accounted for 29.2% of all deaths in Singapore. Wearable devices are ubiquitous, easy to use, and may allow for screening and further monitoring of a large population of patients.
This research proposes to leverage PPG technology, together with artificial intelligence, and incorporate this into affordable wearable lifestyle devices, wrist-worn and in-ear, to accurately monitor continuously and non-invasively glucose levels in humans. A simple non-invasive tool to monitor blood glucose will be developed, and alerts will be issued when the blood glucose level falls in the unhealthy range. The standard glucometer will be used to calibrate and validate the PPG measurements of blood glucose. This study targets to recruit and measure the blood glucose of 500 participants from KK Women's and Children's Hospital.
The primary aims of this study are: (1) Calibrate and validate PPG measurements of blood glucose, obtained both the wrist-worn and in-ear PPG devices, against the standard glucometer; (2) To develop a risk prediction model to identify subjects with blood glucose in the unhealthy range, using both subject characteristics and important features extracted from the PPG measurements using machine learning techniques.
The secondary aim of this study is to validate that in-ear and wrist-worn wearables both provide relative accurate heart rate and heart rate interval measurements.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm: Healthy Participants | Other | Device: Actxa BGM Tracker (GLO2), Device: SVT In-Ear Prototype (IEP)All participants will be administered with the In-Ear and Wearable devices concurrently for 8 minutes while the application records the readings from the devices. Participants with the first glucometer reading of less than 11.1 mmol/L will be required to return one-hour post sugary drink consumption for a second reading with both devices. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 21 years and above
- Are able to walk to, take public transport to or drive to the testing site independently
- Able to understand written and spoken English
Key exclusion criteria (5 listed)
- Have difficulty in giving informed consent
- Have a pacemaker
- Are diagnosed with hypertension
- Are on anti-hypertensive drugs
- Are pregnant
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 |
|---|---|---|
| Actxa BGM Tracker (GLO2)Wrist-worn wearable | Device | Single-Arm: Healthy Participants |
| SVT In-Ear Prototype (IEP)In-Ear wearable | Device | Single-Arm: Healthy Participants |
Primary outcome
Capillary blood glucose level using the glucometer and PPG signal readings
Time frame: Both the PPG signals and capillary blood glucose will be collected at the same time during the visit lasting up to 2 hour per subject. A total of 500 subjects will be recruited up to 6 months
Raw PPG signal readings obtained from the devices will be collected via an application on a phone. Capillary glucose reading will be obtained using a glucometer at the same sitting.
Risk prediction model of diabetes using PPG features on the wearables
Time frame: The study will be completed within 6 months involving 500 subjects. Data analysis and risk prediction model will be completed up to 12 months
This study aims to develop means for non-invasive measurement of blood glucose and to assist with the early detection of diabetes among subjects who do not exhibit any noticeable signs of the disease. PPG data will be collected from the wearables, and the standard glucometer will be used to calibrate and validate these PPG measurements of blood glucose. The objective is to calibrate and evaluate PPG as a means for assessing and monitoring blood glucose levels. The effects of each of the PPG variables collected will be assessed by its ability to detect an increased blood glucose level, in terms of sensitivity, specificity, and positive and negative predictive values. A risk prediction model will be developed to identify subjects with blood glucose in the unhealthy range, using both subject characteristics and important features extracted from the PPG measurements using artificial intelligence and machine learning techniques.
1 secondary outcome
Validate that in-ear and wrist-worn wearables both provide relative accurate heart rate and heart rate interval measurements.
Time frame: Subjects will be assessed at one visit study. Total duration of the study is 15mins for subjects whose capillary blood glucose is greater than or equal to 11.1mmol/L, and about 90minutes for those less than 11.1mmol/L.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- BackgroundKviesis-Kipge, E., Zaharans, J., Rubenis, O., & Grabovskis, A. A photoplethysmography device for multipurpose blood circulatory system assessment. In European Conference on Biomedical Optics (p. 80900W). Optical Society of America.
- Background: PubMed 21696930Monte-Moreno E. Non-invasive estimate of blood glucose and blood pressure from a photoplethysmograph by means of machine learning techniques. Artif Intell Med. 2011 Oct;53(2):127-38. doi: 10.1016/j.artmed.2011.05.001. Epub 2011 Jun 22.
- BackgroundPhilip, L.A., Rajasekaran, K., & Smily Jeya Jothi, E. Continuous monitoring of blood glucose using photophlythesmograph signal. Proceedings of IEEE International Conference on Innovations in Electrical, Electronics, Instrumentation and Media Technology (ICEEIMT). 2017: 187-191
- BackgroundHina, H. Nadeem and W. Saadeh, A Single LED Photoplethysmography-Based Noninvasive Glucose Monitoring Prototype System. 2019 IEEE International Symposium on Circuits and Systems (ISCAS). 2019; 1-5
- Background: PubMed 31758768De Ridder B, Van Rompaey B, Kampen JK, Haine S, Dilles T. Smartphone Apps Using Photoplethysmography for Heart Rate Monitoring: Meta-Analysis. JMIR Cardio. 2018 Feb 27;2(1):e4. doi: 10.2196/cardio.8802.
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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.
Seng Bin Ang principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actxa BGM Tracker (GLO2) and SVT In-Ear Prototype (IEP) in people with Blood Glucose, High and Blood Glucose, Low, run by KK Women's and Children's Hospital 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 5 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: finished, as of the sponsor's last update on 21 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary blood glucose level using the glucometer and PPG signal readings (time frame: Both the PPG signals and capillary blood glucose will be collected at the same time during the visit lasting up to 2 hour per subject. A total of 500 subjects will be recruited up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504096, which also lists 5 linked publications.
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 21 Feb 2023.