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Feasibility of ECG-Based Glucose Monitoring System | Clinical Trials | Clareo Health

RECRUITING

Feasibility of ECG-Based Glucose Monitoring System

Feasibility Assessment of Novel ECG-Based Continuous Glucose Monitoring System

NCT06883682•Singular Wings Medical Co., Ltd.

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+5 more criteria

Locations (1)

Landseed International Hospital

Taoyuan District, Taiwan

Key Dates

Start Date

February 10, 2025

Primary Completion Date

August 31, 2025

Completion Date

September 30, 2025

Last Updated

March 21, 2025

Enrollment

165

ESTIMATED participants

Conditions

Diabetes Mellitus

Interventions

No intervention

OTHER

Contacts

Jasper Yang, Ph.D.

CONTACT

886 3667 5801 jasper@singularwings.com

Jesse Liao

CONTACT

886 3667 5801 jesse@singularwings.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility of ECG-Based Glucose Monitoring System

Inclusion Criteria

Exclusion Criteria

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