NCT05765097

Clinical Application of an Open-source Artificial Pancreas System in Adult Inpatients With Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Artificial pancreas treatment	five to seven days treatment by artificial pancreas system

Timeline

• Start date: 2022-09-28
• Primary completion: 2023-05-31
• Completion: 2023-12-30
• First posted: 2023-03-13
• Last updated: 2024-03-01

Locations

1 site across 1 country: China