Feasibility of ECG-Based Glucose Monitoring System

Официальное название

Feasibility Assessment of Novel ECG-Based Continuous Glucose Monitoring System

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое No intervention
  No intervention is conducted in this study.

Первичные конечные точки

• To assess the accuracy of glucose level determined by the glucose detection model through ECG data and blood glucose monitoring values. [Срок оценки: 14 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 1 центр

• Landseed International Hospital — Taoyuan

Идентификаторы

NCT: NCT06883682 · SWM-BG-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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