Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05504096
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2021-11-19
Brief Title:
Calibration and Evaluation of Non-Invasive Wireless Blood Glucose Monitoring
Sponsor:
KK Womens and Childrens Hospital
Organization:
KK Womens and Childrens Hospital
Study Overview
Official Title:
Calibration and Evaluation of Non-Invasive Wireless Blood Glucose Monitoring
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Diabetic patients have a two to three-fold higher risk of developing cardiovascular disease and that cardiovascular diseases accounted for 292 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 Womens and Childrens Hospital
Diabetic patients have a two to three-fold higher risk of developing cardiovascular disease and that cardiovascular diseases accounted for 292 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 Womens and Childrens 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 093 and mean absolute percentage errors ranging from 33 to 62 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 292 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 Womens and Childrens 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
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 093 and mean absolute percentage errors ranging from 33 to 62 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 292 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 Womens and Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None