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

Recruiting now · Not applicable

Conditions studied: Diabetes Mellitus Patients With Kidney Transplantation

In brief

Objective: To evaluate the short-term blood glucose control effect of the closed-loop system combined with a regular insulin pump and continuous glucose monitoring (CGM) in hospitalized patients with diabetes after kidney transplantation, explore its clinical application value, and provide precise and personalized blood glucose management plans. Methods: A clinical comparative study will be conducted. This will be the first study focusing on hospitalized patients with diabetes after kidney transplantation. The advanced closed-loop system technology will be introduced. Expected Results: The study aims to fill the gap in this field, offer new ideas and solutions for clinical blood glucose management of these patients, and promote the development of diabetes treatment technologies by comparing the short-term blood glucose control effects of the closed-loop system and the regular insulin pump combined with CGM.

Key facts

Study ID

NCT06962410

Run by

Shanxi Bethune Hospital

People needed

30

Starts

2025-04-01

Expected to finish

2027-08-31

Last updated by the study team

2025-05-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (enrolling)

Full record on ClinicalTrials.gov

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