Blood Glucose, High Clinical Trial
Official title:
Calibration and Evaluation of Non-Invasive Wireless Blood Glucose Monitoring
Verified date | February 2023 |
Source | KK Women's and Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | February 18, 2023 |
Est. primary completion date | February 18, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Have difficulty in giving informed consent - Have a pacemaker - Are diagnosed with hypertension - Are on anti-hypertensive drugs - Are pregnant |
Country | Name | City | State |
---|---|---|---|
Singapore | KK Women's and Children's Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
KK Women's and Children's Hospital | Actxa Pte Ltd |
Singapore,
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. — View Citation
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
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. — View Citation
Philip, 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 | |
Primary | 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. |
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 | 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. |
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. |
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