BGEM Use as Blood Glucose Prediction Model in T2DM Population of Indonesia

NCT ID: NCT06642467

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

885 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-30

Study Completion Date

2024-10-05

Brief Summary

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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

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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.

Conditions

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Diabete Type 2

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diabetic Group

Subjects age 18-59 years old who was diagnosed with type 2 diabetes mellitus, or pre DM or known to have abnormal Hba1c or blood glucose results

BGEM

Intervention Type DEVICE

BGEM is an ai driven model to predict blood glucose using ppg sensor

Non diabetic Group

Subjects age 18-59 years old who never diagnosed to have diabetes mellitus or pre DM

BGEM

Intervention Type DEVICE

BGEM is an ai driven model to predict blood glucose using ppg sensor

Interventions

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BGEM

BGEM is an ai driven model to predict blood glucose using ppg sensor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age between 18-59 yo
* diabetic or non diabetic
* healthy enough to undergoes normal daily activity

Exclusion Criteria

* o Wears a pacemaker

* Is currently pregnant
* Has an infection
* Has a fever
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actxa

UNKNOWN

Sponsor Role collaborator

Lif

UNKNOWN

Sponsor Role collaborator

Krida Wacana Christian University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ukrida Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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KridaWacanaCU

Identifier Type: -

Identifier Source: org_study_id

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