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Recruiting NCT06883682

Feasibility of ECG-Based Glucose Monitoring System

Trial Parameters

Condition Diabetes Mellitus
Sponsor Singular Wings Medical Co., Ltd.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 165
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-02-10
Completion 2025-08-31
Interventions
No intervention

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.

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 ketoacid

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