Feasibility of ECG-Based Glucose Monitoring System

Last updated: March 18, 2025
Sponsor: Singular Wings Medical Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Treatment

No intervention

Clinical Study ID

NCT06883682
SWM-BG-001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

  • Males and females, age 18 years or older.

  • Subjects can communicate clearly, fully understand the informed consent form, andare aware of the rights and obligations of the study.

  • Category 1: Subjects without a medical history of hyperglycemia / hypoglycemia ortype 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

Exclusion Criteria:

  • Subjects suffering from insomnia or severe digestive system disorders within 3months prior to the screening visit.

  • Subjects who are addicted to alcohol or caffeine.

  • Existing severe cardiac conditions such as recent myocardial infarction or advancedheart 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 intellectualor mental disabilities.

  • Has a concomitant disease or condition that may compromise subject safety such asunstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, orany 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 pacemakerand so on.

  • Subjects on certain drugs known to cause arrhythmias or significantly impact kidneyfunction 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 thestudy.

  • Any other clinical condition that, in the investigator's judgment, would potentiallycompromise study compliance or the ability to evaluate safety/efficacy.

Study Design

Total Participants: 165
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
February 10, 2025
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Landseed International Hospital

    Taoyuan,
    Taiwan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.