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 ofDiabetes in China (2024 Edition)": A patient can be diagnosed with diabetes ifhe/she presents typical symptoms of diabetes (including polydipsia, polyuria,polyphagia, and unexplained weight loss) and meets one of the four criteria: ①random blood glucose ≥ 11.1 mmol/L; ② fasting blood glucose ≥ 7.0 mmol/L; ③ 2 - hourpost - load blood glucose during an oral glucose tolerance test ≥ 11.1 mmol/L. Forpatients without typical symptoms, the diagnosis requires two abnormal test resultsobtained either simultaneously or at two different time points.

• Able to correctly use insulin pumps and CGM devices, and has certain learning andoperational 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, suchas 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 coagulationfunction.

• The patient has diseases related to glucose metabolism, such as uncontrolledhyperthyroidism, 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 hematologicalmalignancies).

• The patient has impaired consciousness or mental illness, lacks self-control, and isunable to express clearly.

• Lactating women, pregnant women, or women who plan to become pregnant during thetrial period.

• The patient is allergic to the drugs involved in the clinical diagnosis andtreatment plan.

• The patient is currently using other closed-loop systems.

• Populations not suitable for conventional insulin pump therapy andcontraindications.

• 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 inthe clinical trial.