Feasibility of ECG-Based Glucose Monitoring System

Recruiting now

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT06883682

Run by

Singular Wings Medical Co., Ltd.

People needed

165

Starts

2025-02-10

Expected to finish

2025-09-30

Last updated by the study team

2025-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Landseed International Hospital — Taoyuan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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