Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT06642467
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2024-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BGEM Use as Blood Glucose Prediction Model in T2DM Population of Indonesia
Sponsor:
Krida Wacana Christian University
Organization:
Study Overview
Official Title:
BGEM Use as Blood Glucose Prediction Model in T2DM Population of Indonesia
Status:
COMPLETED
Status Verified Date:
2024-10
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:
Using signals from consumer-grade PPG sensors on wrist wearables, smart rings or hearables, BGEM® AI model computes the relevant digital biomarkers correlated with the change of blood glucose level to predict a blood glucose result for monitoring and evaluating diabetic risks Ukrida in collaboration with Actxa \& Lif aims to enhance the current model's prediction accuracy to predict the blood glucose levels of individuals almost as accurately as a glucometer. To achieve this, Actxa aims to collect data from around 500 individuals with diabetes in this exercise and 400 healthy or undiagnosed (prediabetes/diabetes) individuals.
Detailed Description:
Background Powered by our AI-driven algorithm, the Actxa's Blood Glucose Evaluation and Monitoring (BGEM®) is a cloud-based technology that enables wearables with photoplethysmography (PPG) sensors to monitor and evaluate diabetic risk of individuals regularly in a non-invasive way.
Using signals from consumer-grade PPG sensors on wrist wearables, smart rings or hearables, BGEM® AI model computes the relevant digital biomarkers correlated with the change of blood glucose level to predict a blood glucose result for monitoring and evaluating diabetic risks. Our previous study has shown the potential of using PPG sensors to detect elevated blood glucose levels among a non-diabetic population1.
Objective Ukrida in collaboration with Actxa \& Lif to enhance the current model's prediction accuracy to predict the blood glucose levels of individuals almost as accurately as a glucometer. To achieve this, Actxa aims to collect data from around 500 individuals with diabetes in this exercise and 400 healthy or undiagnosed (prediabetes/diabetes) individuals, as part of Actxa's collaboration with UKRIDA Hospital.
With the data collected, our algorithm holds the potential to significantly improve the management of blood glucose levels for people with and without diabetes, ultimately enhancing their overall quality of life.
Using signals from consumer-grade PPG sensors on wrist wearables, smart rings or hearables, BGEM® AI model computes the relevant digital biomarkers correlated with the change of blood glucose level to predict a blood glucose result for monitoring and evaluating diabetic risks. Our previous study has shown the potential of using PPG sensors to detect elevated blood glucose levels among a non-diabetic population1.
Objective Ukrida in collaboration with Actxa \& Lif to enhance the current model's prediction accuracy to predict the blood glucose levels of individuals almost as accurately as a glucometer. To achieve this, Actxa aims to collect data from around 500 individuals with diabetes in this exercise and 400 healthy or undiagnosed (prediabetes/diabetes) individuals, as part of Actxa's collaboration with UKRIDA Hospital.
With the data collected, our algorithm holds the potential to significantly improve the management of blood glucose levels for people with and without diabetes, ultimately enhancing their overall quality of life.
Study Oversight
Has Oversight DMC:
False
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?: