Using ECG to monitor glucose levels in diabetes patients
Feasibility Assessment of Novel ECG-Based Continuous Glucose Monitoring System
This study is testing if a portable ECG device can help monitor blood sugar levels in diabetes patients to see if it works as well as traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 165 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Singular Wings Medical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT06883682 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of a continuous glucose monitoring system based on ECG data in adult subjects. Approximately 165 participants will be categorized based on their risk of hyperglycemia or hypoglycemia and will wear a portable ECG recorder while using three blood glucose monitoring methods over a 21-day period. The collected data will be utilized to train an artificial intelligence algorithm to develop a model for blood glucose detection using ECG features.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older, with or without diabetes, categorized by their risk of glucose level fluctuations.
Not a fit: Patients with severe cardiac conditions or recent myocardial infarction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive and continuous method for glucose monitoring in diabetic patients.
How similar studies have performed: While the use of ECG for glucose monitoring is a novel approach, similar studies have shown promise in utilizing wearable technology for health monitoring.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taoyuan
- Landseed International Hospital — Taoyuan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Ying-Kuang Lin, M.D. Ph.D. — Landseed International Hospital
- Study coordinator: Jasper Yang, Ph.D.
- Email: jasper@singularwings.com
- Phone: 886 3667 5801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.