Calibration and Evaluation of Non-Invasive Wireless Blood Glucose Monitoring

NCT05504096 | Completed

• 1 other identifier: 2020/2968
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Blood Glucose, High; Blood Glucose, Low

Keywords

Blood Glucose Monitoring; Wearable; Photoplethysmography (PPG); Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Validate that in-ear and wrist-worn wearables both provide relative accurate heart rate and heart rate interval measurements.

  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.

Study Arms (1)

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.

Device: Actxa BGM Tracker (GLO2); Device: SVT In-Ear Prototype (IEP)

Interventions

Actxa BGM Tracker (GLO2) DEVICE

Wrist-worn wearable

Single-Arm: Healthy Participants

SVT In-Ear Prototype (IEP) DEVICE

In-Ear wearable

Single-Arm: Healthy Participants

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have difficulty in giving informed consent
• Have a pacemaker
• Are diagnosed with hypertension
• Are on anti-hypertensive drugs
• Are pregnant

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Actxa Pte Ltd: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (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.

  BACKGROUND

• 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.

  PMID: 21696930 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 31758768 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Seng Bin Ang

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Head of Family Medicine Service and Head of Menopause Unit

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: August 17, 2022
• Study Start: October 8, 2021
• Primary Completion: February 18, 2023
• Study Completion: February 18, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

SG (1)