An interventional study of AP-A Dosage Decision Support System in Diabetes Mellitus, Type 1, sponsored by Peking University People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
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.
Device: AP-A Dosage Decision Support System
The injection dose of the control group was determined by the doctor solely.
Device: AP-A Dosage Decision Support System
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.
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.
Time frame: At the end of the treatment period
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.
Time frame: At the end of the treatment period
Other Secondary Outcomes1
The proportion of glucose data stored by CGM during the treatment period that is in the range of 3.0-3.8mmol/L.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the end of the treatment period
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital