Using a closed-loop system to manage diabetes in kidney transplant patients

Application of a Hybrid Closed-Loop Artificial Pancreas System in Patients With Diabetes After Kidney Transplantation: An Open-Label, Randomized Controlled Trial

This study is testing a new system that combines an insulin pump and glucose monitor to see if it can help manage blood sugar levels better in people with diabetes who have had a kidney transplant.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanxi Bethune Hospital (Academic / other)
• Locations: 1 site (Taiyuan, Shanxi)
• Trial ID: NCT06962410 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a hybrid closed-loop system combined with a regular insulin pump and continuous glucose monitoring (CGM) for managing blood glucose levels in hospitalized patients with diabetes after kidney transplantation. The study aims to provide personalized blood glucose management plans and fill the existing gap in research focused on this specific patient population. By comparing the short-term blood glucose control effects of the closed-loop system against traditional methods, the trial seeks to explore the clinical application value of this advanced technology in diabetes treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 who have diabetes and have undergone kidney transplantation.

Not a fit: Patients who have experienced acute diabetic complications within the past month may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve blood glucose control for patients with diabetes after kidney transplantation.

How similar studies have performed: While this specific approach is novel, other studies have shown success with closed-loop systems in diabetes management, indicating potential for positive outcomes.

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.

Where this trial is running

Taiyuan, Shanxi

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

Study contacts

• Study coordinator: Shiwei Liu, Doctor

Conditions Diabetes Mellitus Patients With Kidney Transplantation