NCT05504096

Calibration and Evaluation of Non-Invasive Wireless Blood Glucose Monitoring

Completed NA Last updated 21 February 2023

What this trial tests

NA trial testing Actxa BGM Tracker (GLO2) in Blood Glucose, High in 500 participants. Completed in 18 February 2023.

Timeline

8 October 2021

Primary endpoint
18 February 2023

18 February 2023

Quick facts

Lead sponsor	KK Women's and Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	500
Start date	8 October 2021
Primary completion	18 February 2023
Estimated completion	18 February 2023
Sites	1 location across Singapore

Drugs / interventions tested

• Actxa BGM Tracker (GLO2)
• SVT In-Ear Prototype (IEP)

Conditions studied

• Blood Glucose, High — all drugs for Blood Glucose, High →
• Blood Glucose, Low — all drugs for Blood Glucose, Low →

Sponsor

KK Women's and Children's Hospital

Who can join

21 and older, any sex, with Blood Glucose, High or Blood Glucose, Low. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Assessing Elevated Blood Glucose Levels Through Blood Glucose Evaluation and Monitoring Using Machine Learning and Wearable Photoplethysmography Sensors: Algorithm Development and Validation.
   Shi B, Dhaliwal SS, Soo M, Chan C, et al · · 2023 · cited 4× · PMID 38875549 · DOI 10.2196/48340
2. Assessment of Blood Glucose Measurement Using New Noninvasive Technology: Protocol and Methodology.
   Suradji EW, Dhaliwal SS, Li-Feng Z, Zhou E, et al · · 2026 · PMID 41505712 · DOI 10.2196/76558