NCT06883682

Feasibility of ECG-Based Glucose Monitoring System

Feasibility Assessment of Novel ECG-Based Continuous Glucose Monitoring System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 165 (estimated)
• Sponsor: Singular Wings Medical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, open-label clinical trial to assess the feasibility of using ECG information in estimating glucose level continuously in adult subjects.

Detailed description

About 165 subjects distributed in 3 categories according to the risk of developing events of hyperglycemia or hypoglycemia will be enrolled. Subjects will wear a portable ECG recorder to monitor ECG information and use 3 blood glucose monitoring methods to monitor blood glucose level over time. All data will be pooled together to train a specific artificial intelligence (AI) algorithm to conduct a blood glucose detection model using ECG features. The trial period is about 21 days.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	No intervention	No intervention is conducted in this study.

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-08-31
• Completion: 2025-09-30
• First posted: 2025-03-19
• Last updated: 2025-03-21

Locations

1 site across 1 country: Taiwan