Clinical trial NCT06883682: Feasibility of ECG-Based Glucose Monitoring System
Official title: Feasibility Assessment of Novel ECG-Based Continuous Glucose Monitoring System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Keywords: ECG
glucose
singular wings
Lead sponsor: Singular Wings Medical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Landseed International Hospital
First posted: 2025-03-19
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers or subjects with diabetes mellitus.

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 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 criteria: 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.

Primary outcomes:
measure: To assess the accuracy of glucose level determined by the glucose detection model through ECG data and blood glucose monitoring values.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Landseed International Hospital
Study officials:
affiliation: Landseed International Hospital
name: Ying-Kuang Lin, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: