Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06883682

Feasibility of ECG-Based Glucose Monitoring System

Led by Singular Wings Medical Co., Ltd. · Updated on 2025-03-21

165

Participants Needed

1

Research Sites

33 weeks

Total Duration

On this page

Sponsors

S

Singular Wings Medical Co., Ltd.

Lead Sponsor

L

Landseed International Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Feasibility of ECG-Based Glucose Monitoring System

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females, age 18 years or older.
  • Subjects who can communicate clearly, fully understand the informed consent form, and are aware of the rights and obligations of the study.
  • Category 1: Subjects without a medical history of hyperglycemia, hypoglycemia, or type 1 or type 2 diabetes.
  • Category 2: Subjects with diabetes mellitus and HbA1c value from 5.5% to 10%, with eGFR 60 mL/min.
  • Category 3: Subjects with chronic kidney disease and diabetes mellitus, with eGFR less than 60 mL/min.
  • Willing and able to participate in all aspects of the study.
Not Eligible

You will not qualify if you...

  • Subjects with insomnia or severe digestive system disorders within 3 months before screening.
  • Subjects addicted to alcohol or caffeine.
  • Subjects with severe cardiac conditions such as recent myocardial infarction or advanced heart failure within 6 months before screening.
  • Subjects who experienced diabetic ketoacidosis within 6 months before screening.
  • Vulnerable groups or higher risk individuals such as HIV carriers, pregnant women or planning pregnancy during the study, breastfeeding mothers, subjects with rare diseases, physical disabilities, incurable fatal diseases, nursing home dependents, incapacity, or intellectual or mental disabilities.
  • Subjects with concomitant diseases compromising safety like unstable coronary heart disease, cystic fibrosis, serious psychiatric disorders, or other uncontrolled medical conditions.
  • Subjects with active infection or malignancy needing acute therapy.
  • Subjects with coagulation disorders.
  • Subjects allergic to medical adhesives.
  • Subjects with cardiac implantable devices like pacemakers.
  • Subjects on drugs known to cause arrhythmias or significantly affect kidney function or blood glucose (except current daily medications).
  • Subjects who used defibrillators within 3 months before screening.
  • Subjects currently in another device or drug study.
  • Subjects currently receiving or planning dialysis during the study.
  • Any other clinical condition that might affect study compliance or safety evaluation according to investigator judgment.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Landseed International Hospital

Taoyuan, Taiwan

Actively Recruiting

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Research Team

J

Jasper Yang, Ph.D.

CONTACT

J

Jesse Liao

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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