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OpenTrials
Completed

NCT Number: NCT06642467

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

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ukrida Hospital

Jakarta, Jakarta Special Capital Region, 11510, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BGEM

Device

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

Primary outcomes

  1. Prediction value of BGEM

    Time frame: July-December 2024

    Result of predictive model will be compared with blood glucose analysis

  2. Prediction value of BGEM

    Time frame: July-December 2024

    Result of predictive model will be compared with Hba1c

Secondary outcomes

  1. Variables influencing BGEM

    Time frame: July-December 2024

    Analysis to determine any variables from subjects that influence BGEM

Sponsors and collaborators

Lead sponsor

Krida Wacana Christian University

Other

Collaborators

  • Actxa
  • Lif

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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