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| Name | Class |
|---|---|
| Landseed International Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitoring arm | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention is conducted in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the accuracy of glucose level determined by the glucose detection model through ECG data and blood glucose monitoring values. | Part of the ECG and glucose data will be used for AI model training, and the rest will be used for accuracy testing (such as through the comparison of mean absolute relative difference (MARD) between glucose levels from different methods). | 14 days |
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Inclusion Criteria:
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:
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Healthy volunteers or subjects with diabetes mellitus.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasper Yang, Ph.D. | Contact | 886 3667 5801 | jasper@singularwings.com | |
| Jesse Liao | Contact | 886 3667 5801 | jesse@singularwings.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying-Kuang Lin, M.D. Ph.D. | Landseed International Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landseed International Hospital | Recruiting | Taoyuan | Taiwan |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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