Feasibility of ECG-Based Glucose Monitoring System

NCT06883682 | Recruiting

• 1 other identifier: SWM-BG-001
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Keywords

ECG; glucose; singular wings

Outcome Measures

Primary Outcomes (1)

• To assess the accuracy of glucose level determined by the glucose detection model through ECG data and blood glucose monitoring values.

  Part of the ECG and glucose data will be used for AI model training, and the rest will be used for accuracy testing (such as through the comparison of mean absolute relative difference (MARD) between glucose levels from different methods).

  14 days

Study Arms (1)

Monitoring arm

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention is conducted in this study.

Monitoring arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers or subjects with diabetes mellitus.

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.

Sponsors & Collaborators

• Singular Wings Medical Co., Ltd.: lead
• Landseed International Hospital: collaborator

Study Sites (1)

Landseed International Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ying-Kuang Lin, M.D. Ph.D.

  Landseed International Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasper Yang, Ph.D.

CONTACT

886 3667 5801; jasper@singularwings.com

Jesse Liao

CONTACT

886 3667 5801; jesse@singularwings.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 19, 2025
• Study Start: February 10, 2025
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)