Hybrid Closed-Loop in Diabetes Post-Kidney Transplant: A Randomized Trial

Inclusion criteria:

• Aged 18 - 70 years;
• Meets the diagnostic criteria in the "Guidelines for Prevention and Control of Diabetes in China (2024 Edition)": A patient can be diagnosed with diabetes if he/she presents typical symptoms of diabetes (including polydipsia, polyuria, polyphagia, and unexplained weight loss) and meets one of the four criteria: ① random blood glucose ≥ 11.1 mmol/L; ② fasting blood glucose ≥ 7.0 mmol/L; ③ 2 - hour post - load blood glucose during an oral glucose tolerance test ≥ 11.1 mmol/L. For patients without typical symptoms, the diagnosis requires two abnormal test results obtained either simultaneously or at two different time points.
• Able to correctly use insulin pumps and CGM devices, and has certain learning and operational abilities;
• Agrees to participate in the study and signs the informed consent form.

Exclusion criteria:

• The patient has experienced acute diabetic complications within the past month, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.
• The patient has severe symptoms of hypoglycemic intolerance.
• The patient has skin diseases such as rashes and prurigo, or abnormal coagulation function.
• The patient has diseases related to glucose metabolism, such as uncontrolled hyperthyroidism, uncontrolled hypothyroidism, Cushing's syndrome, etc.
• The patient has severe diseases of the liver, kidneys, gastrointestinal tract, hematopoietic system, brain, circulatory system, etc.
• Patients with malignant tumors (including solid tumors and hematological malignancies).
• The patient has impaired consciousness or mental illness, lacks self-control, and is unable to express clearly.
• Lactating women, pregnant women, or women who plan to become pregnant during the trial period.
• The patient is allergic to the drugs involved in the clinical diagnosis and treatment plan.
• The patient is currently using other closed-loop systems.
• Populations not suitable for conventional insulin pump therapy and contraindications.
• The patient has known or suspected insulin allergy, or is allergic to adhesive tape, insulin pumps, or CGM devices.
• Other situations where the investigator deems the patient unfit to participate in the clinical trial.