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Open-source artificial pancreas system has been applied in clinical settings abroad for several years, and its safety and effectiveness has been reported by many literature. However, there is no reporting of its clinical application in China. Taking the inpatients with diabetes in the Department of Endocrinology as the starting point of research, participants would like to explore the safety and efficacy of open source artificial pancreas system in domestic clinical application, further to promote the development and landing of artificial pancreas technology in China, and finally to provide better treatment options for the majority of diabetes patients in China.
Artificial Pancreas (AP), as the treatment of type 1 diabetes, has attracted more and more attention in recent years. The artificial pancreas system is an Automatic Insulin Delivery/AID device that consists of three main elements: The Continuous Glucose Monitoring , insulin pump and central algorithm control system ,it can automatically calculate the immediate insulin infusion dose according to the immediate blood glucose, giving continuous subcutaneous infusion, and maximizing the simulation of the physiological secretion pattern of human insulin, so as to achieve closed-loop blood glucose management. Compared with traditional insulin pump therapy , artificial pancreas system has advantages such as higher intelligence, more stable blood glucose control, and less burden of blood glucose management. While greatly improving patients' quality of life, its safety has also been verified in a number of foreign clinical studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial pancreas group | Experimental | Using artificial pancreas system (composed of a CGM, a pump and AndroidAPS software) to treat adult patients with diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial pancreas treatment | Device | five to seven days treatment by artificial pancreas system |
|
| Measure | Description | Time Frame |
|---|---|---|
| TIR | Time in range | 5-7days |
| Measure | Description | Time Frame |
|---|---|---|
| mean BG | mean blood glucose | 5-7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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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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The study was conducted in two phases: one subject only participated in one of the phases.
In phase 1, the semi-closed-loop open source AP system was used to treat the subjects, and the nurse manually entered the initial basal and the bolus instruction for three meals into the system according to the doctor's advice. When the Phase 1 trial is completed, all subjects have no serious adverse events and have been evaluated and confirmed by participants, the phase 2 trial can proceed. In phase 2, the full closed-loop open source AP system was used to treat the subjects. The nurses manually entered initial basal into the system according to the doctor's advice to start treatment, and the open source AP system automatically gave infusion instructions for boluses.Each phase will enroll up to 10 subjects.
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