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| Name | Class |
|---|---|
| Hebei Provincial People's Hospital | UNKNOWN |
| Xingtai People's Hospital | OTHER |
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This study is designed as a blinded, multi-center, non-inferiority randomized controlled clinical trial. It aims to enroll hospitalized T1D diabetes patients, ensuring an equal distribution with a 1:1 ratio between the intervention and control groups. The trial is set to take place across three locations in China: Peking University People's Hospital, Hebei Provincial People's Hospital, and Xingtai People's Hospital. Before participating, all subjects are required to provide their consent by signing a written informed consent form. Within the framework of the trial, the intervention group will receive insulin dosage recommendations from AP-A, subject to approval by a physician, whereas the control group will be treated with insulin dosages according to the current clinical guidelines established by their physicians.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AP-A Dosage Decision Support System | Experimental | The AP-A Dosage Decision Support System represents a new solution in diabetes care, offering customized insulin dosage recommendations to patients. This system is a product of integrating four pivotal modules: the individualized model learning module, the risk-sensitive control module, the Bayesian optimization module, and the safety constraint module. Together, they establish a robust framework that employs advanced computational methodologies to deliver precise and personalized insulin dosage guidance, significantly improving the effectiveness and safety of diabetes treatment plans. The actual injection dose in the intervention group was executed by the doctor after approval based on the recommendation of the AP-A Dosage Decision Support System. |
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| Physician decision-making | Active Comparator | The injection dose of the control group was determined by the doctor solely. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP-A Dosage Decision Support System | Device | The AP-A Dosage Decision Support System represents a new solution in diabetes care, offering customized insulin dosage recommendations to patients. This system is a product of integrating four pivotal modules: the individualized model learning module, the risk-sensitive control module, the Bayesian optimization module, and the safety constraint module. Together, they establish a robust framework that employs advanced computational methodologies to deliver precise and personalized insulin dosage guidance, significantly improving the effectiveness and safety of diabetes treatment plans. The actual injection dose in the intervention group was executed by the doctor after approval based on the recommendation of the AP-A Dosage Decision Support System. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range (TIR) | The proportion of time that the glucose levels, as recorded by CGM during the treatment period, are within the range of 3.9mmol/L to 10.0mmol/L. This metric can be directly obtained by the algorithm system through closed-loop reading of CGM data. | At the end of the treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Time Below Range (TBR) | The proportion of time that the glucose levels, as recorded by CGM during the treatment adjustment period, are below 3.9mmol/L. | At the end of the treatment period |
| Other Secondary Outcomes1 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The proportion of glucose data stored by CGM during the treatment period that is in the range of 3.0-3.8mmol/L.
| At the end of the treatment period |
| Other Secondary Outcomes2 | The proportion of glucose data stored by CGM during the treatment adjustment period that is below 3.0mmol/L. | At the end of the treatment period |
| Other Secondary Outcomes3 | The area under the curve (AUC) of glucose levels below 3.9mmol/L in the Ambulatory Glucose Profile (AGP) during the treatment adjustment period. | At the end of the treatment period |
| Other Secondary Outcomes4 | The proportion of glucose data stored by CGM during the treatment adjustment period that is above 10.0mmol/L. | At the end of the treatment period |
| Other Secondary Outcomes5 | The proportion of glucose data stored by CGM during the treatment adjustment period that is above 13.3mmol/L. | At the end of the treatment period |
| Other Secondary Outcomes6 | The area under the curve (AUC) of glucose levels below 10.0mmol/L in the AGP during the treatment adjustment period. | At the end of the treatment period |
| Other Secondary Outcomes7 | The mean of the glucose data stored by CGM during the treatment adjustment period (MEAN). | At the end of the treatment period |
| Other Secondary Outcomes8 | The standard deviation of the glucose data stored by CGM during the treatment adjustment period (SD). | At the end of the treatment period |
| Other Secondary Outcomes9 | The discrepancy between the physician-approved dosage and the AI-recommended dosage in the intervention group. | At the end of the treatment period |
| Other Secondary Outcomes10 | The number of times the physician-approved dosage differs from the AI-recommended dosage in the intervention group. | At the end of the treatment period |
| Other Secondary Outcomes11 | In the intervention group, the proportion of time that the glucose levels are within the range of 3.9mmol/L to 10.0mmol/L within 4 hours after insulin injection when there is a discrepancy between the physician-approved dosage and the algorithm-recommended dosage. | At the end of the treatment period |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |