Feasibility of ECG-Based Glucose Monitoring System

Feasibility Assessment of Novel ECG-Based Continuous Glucose Monitoring System

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: No intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 165

Contacts and Locations

• Study Contact: Name: Jasper Yang, Ph.D.; Phone Number: 886 3667 5801; Email: jasper@singularwings.com
• Study Contact Backup: Name: Jesse Liao; Phone Number: 886 3667 5801; Email: jesse@singularwings.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Recruiting
    • Landseed International Hospital
    • Contact: Yi-Shu Chang; Phone Number: 886-3494-1234; Email: changys@landseed.com.tw
    • Contact: Ying-Kuang Lin, M.D. Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers or subjects with diabetes mellitus.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; No intervention is conducted in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Singular Wings Medical Co., Ltd.
• Collaborators: Landseed International Hospital
• Investigators: Principal Investigator: Ying-Kuang Lin, M.D. Ph.D., Landseed International Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: glucose; ECG; singular wings
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: SWM-BG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Unnecessary

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No