NCT06962410 Hybrid Closed-Loop in Diabetes Post-Kidney Transplant: A Randomized Trial
| NCT ID | NCT06962410 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanxi Bethune Hospital |
| Condition | Diabetes Mellitus Patients With Kidney Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-04-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06962410 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Diabetes Mellitus Patients With Kidney Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06962410 currently recruiting?
Yes, NCT06962410 is actively recruiting participants. Contact the research team at lswspring6@aliyun.com for enrollment information.
Where is the NCT06962410 trial being conducted?
This trial is being conducted at Taiyuan, China.
Who is sponsoring the NCT06962410 clinical trial?
NCT06962410 is sponsored by Shanxi Bethune Hospital. The trial plans to enroll 30 participants.
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