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Recruiting NCT06962410

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

Trial Parameters

Condition Diabetes Mellitus Patients With Kidney Transplantation
Sponsor Shanxi Bethune Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2025-04-01
Completion 2026-08-31
Interventions
Hybrid Closed-Loop Artificial Pancreas System

Brief Summary

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.

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, hyperglycem

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