NCT06962410

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanxi Bethune Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Based on the difficulty in blood glucose control for patients with diabetes after kidney transplantation and the insufficiency of previous studies, this research intends to conduct a clinical comparative study to evaluate the short-term blood glucose control effect of the closed-loop system combined with a regular insulin pump and CGM in hospitalized patients with diabetes after kidney transplantation, explore its clinical application value in this patient group, and provide more precise and personalized blood glucose management plans for them. This study will be the first to focus on patients with diabetes after kidney transplantation, especially the hospitalized ones, filling the gap in this field. Meanwhile, by introducing the most advanced closed-loop system technology, it aims to offer new ideas and solutions for the clinical blood glucose management of these patients. Through the comparative analysis of the short-term blood glucose control effects of the closed-loop system and the regular insulin pump combined with CGM, this research aims to provide more precise and personalized treatment strategies for patients with diabetes after kidney transplantation and promote the further development of diabetes treatment technologies.

Conditions

• Diabetes Mellitus Patients With Kidney Transplantation

Interventions

Type	Name	Description
OTHER	Hybrid Closed-Loop Artificial Pancreas System	The pump was loaded with ultra-short-acting insulin (Manufacturer: Novo Nordisk A/S, Denmark; Approval Number: National Drug Approval No. J20050097; Specification: 3 mL: 300 U). The total daily insulin requirement was calculated at 0.2-0.4 U/(kg·d) based on the patient's weight. During operation, the system automatically adjusted the basal rate according to the blood glucose level. After the physician issued a large-dose order based on previous treatment experience and blood glucose conditions, the nurse manually entered the large-dose treatment instruction in the AAPS software.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-08-31
• Completion: 2027-08-31
• First posted: 2025-05-08
• Last updated: 2025-05-08

Locations

1 site across 1 country: China