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Calibration and Evaluation of Non-Invasive Wireless Blood Glucose Monitoring

NCT05504096 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-02-21

No results posted yet for this study

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

Interventions

DEVICE

Actxa BGM Tracker (GLO2)

Wrist-worn wearable

DEVICE

SVT In-Ear Prototype (IEP)

In-Ear wearable

Sponsors & Collaborators

  • Actxa Pte Ltd

    collaborator UNKNOWN

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Seng Bin Ang · KK Women's and Children's Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2023-02-18
Completion
2023-02-18

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05504096 on ClinicalTrials.gov