Status:
RECRUITING
Feasibility of ECG-Based Glucose Monitoring System
Lead Sponsor:
Singular Wings Medical Co., Ltd.
Collaborating Sponsors:
Landseed International Hospital
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
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.
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT06883682
Start Date
February 10 2025
End Date
September 30 2025
Last Update
March 21 2025
Active Locations (1)
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1
Landseed International Hospital
Taoyuan District, Taiwan