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

Launched by SHANXI BETHUNE HOSPITAL · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help manage blood sugar levels in patients with diabetes who have recently received a kidney transplant. The researchers want to see how well a hybrid closed-loop system— which works with an insulin pump and continuous glucose monitoring (CGM) devices—can control blood sugar, compared to just using an insulin pump with CGM. This study is important because it focuses specifically on hospitalized patients, and it hopes to provide better blood sugar management plans tailored to individual needs.

To participate in this trial, patients need to be between 18 and 70 years old and diagnosed with diabetes according to specific guidelines. They should also be able to use insulin pumps and CGM devices correctly. Patients who have had recent severe diabetes complications or other serious health issues may not be eligible. Those who join the study can expect to receive close monitoring and support as they test the new system, and their experiences could help improve diabetes care for others in the future.

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Eligibility criteria

• 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.