Clinical Trials in Taiwan / NCT06883682
Recruiting Observational

Feasibility of ECG-Based Glucose Monitoring System

NCT06883682 · tracked via the Priya Life Science Taiwan tracker
Sponsor
Singular Wings Medical Co., Ltd
Phase
Observational
Started
2025-02-10
Last updated
2025-03-21

Condition(s) studied

Diabetes Mellitus

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention is conducted in this study.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Males and females, age 18 years or older. * Subjects 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 / type 2 diabetes. Category 2: Subjects having diabetes mellitus (DM) and HbA1c value of. 5.5% to 10%, with eGFR ≥ 60 mL/min. Category 3: Subjects having chronic kidney disease (CKD) and diabetes. mellitus (DM), with eGFR \< 60 mL/min. • Willing and able to participate in all aspects of the study. Exclusion Criteria: * Subjects suffering from insomnia or severe digestive system disorders within 3 months prior to the screening visit. * Subjects who are addicted to alcohol or caffeine. * Existing severe cardiac conditions such as recent myocardial infarction or advanced heart failure within 6 months prior to the screening visit. * Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) within 6 months prior to the screening visit. * Subjects who are vulnerable groups or with higher risks, such as HIV carriers, pregnant women or planning to become pregnant within the study duration, breast-feeding mothers, subjects with rare diseases, physical disabilities, incurable fatal diseases, dependents in nursing homes, incapacity, or intellectual or mental disabilities. * Has a concomitant disease or condition that may compromise subject safety such as unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical conditions. * Any active infection or malignancy requiring acute therapy. * Having coagulation disorders. * Has known allergy to medical adhesives. * Subjects using any cardiac related implantable medical devices such as a pacemaker and so on. * Subjects on certain drugs known to cause arrhythmias or significantly impact kidney function or blood glucose levels (except for the current daily use medication). * Subjects have used defibrillators within 3 months prior to the screening visit. * Currently participating in another device or drug study. * Currently receiving dialysis treatment or planning to receive dialysis during the study. * Any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Landseed International Hospital Taoyuan Taiwan Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06883682 on ClinicalTrials.gov ↗ ← All trials in Taiwan