Clinical Application of an Open-source Artificial Pancreas System in Adult Inpatients With Diabetes
Diabetes Mellitus
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: Age is 18~75 years old (including 18 years old and 75 years old), gender is not limited; Patients with type 1 diabetes mellitus (T1DM); Patients with type 2 diabetes mellitus (T2DM) who require insulin therapy; Those who sign the informed consent form and voluntarily participate in this clinical trial; Be able to understand the trial and cooperate with the test procedure, and be able to follow up the observer as required. Exclusion Criteria: Patients who are not suitable for insulin pump therapy; Acute complications of diabetes, such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma; Hyperglycemia with severe circulatory disorders and patients with shock; Cardiac function grade III or above; ALT or AST exceeds the upper limit of normal value by more than 3 times; Serum creatinine more than 442μmol/L; Hemoglobin less than 90g/L; White blood cell count < 4.0×109/L or platelet count <90×109/L; Those who are allergic to adhesive tape; Patients with skin diseases such as rash and prurigo, or abnormal coagulation function; Women who are pregnant or lactating, or those who have a family plan during clinical trials; Those who suffer from mental illness, have no self-control, and cannot express themselves clearly; Those who have participated in clinical studies of other drugs, biologics or medical devices before screening but have not reached the time limit of the primary research endpoint; Other circumstances that participants deems inappropriate to participate in the clinical trial.
Sites / Locations
- Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Experimental
Artificial pancreas group
Using artificial pancreas system (composed of a CGM, a pump and AndroidAPS software) to treat adult patients with diabetes