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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus Patients With Kidney Transplantation

• Registration Number: NCT06962410
• Lead Sponsor: Shanxi Bethune Hospital

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.

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.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-01
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Days Required to Achieve 70% TIR	2 years	The number of days required for a patient to achieve a Time in Range (TIR) of 70%, where TIR is defined as the percentage of time that blood glucose levels are maintained within the target range of 3.9-10.0 mmol/L. This metric is calculated using the formula: TIR = (Time in Range / Total Time) × 100%.
The blood glucose target achievement rate during 5×24 hours of treatment.	2 years	The blood glucose target achievement rate during 5×24 hours of treatment refers to the percentage of time that a patient's blood glucose levels are maintained within the target range (typically 3.9-10.0 mmol/L) over a continuous 5-day (120-hour) treatment period. This metric is used to assess the effectiveness of the treatment regimen in maintaining stable blood glucose levels over an extended period.

Secondary Outcome Measures

Name	Time	Method
Blood Glucose Target Achievement Rate (TAR)	2 years	In the absence of hypoglycaemia, the fasting blood glucose is less than 7.0 mmol/L, and the 2 - h postprandial blood glucose is less than 10.0 mmol/L. The blood glucose target achievement rate within one week of intensive insulin therapy is calculated as: Blood Glucose Target Achievement Rate = (Number of Patients with Blood Glucose under Control / Total Number of Patients) × 100%.
Time Below Range (TBR) ，Time Above Range (TAR)	2 years	Time Below Range (TBR) is the percentage of time that blood glucose is below the target range (\<3.9 mmol/L). It's calculated as TBR = (Time with blood glucose \<3.9 mmol/L / Total time) × 100%. Time Above Range (TAR) is the percentage of time that blood glucose is above the target range (\>10.0 mmol/L). It's calculated as TAR = (Time with blood glucose \>10.0 mmol/L / Total time) × 100%.
Hypoglycemia incidence	2 years	Hypoglycemia incidence rate refers to the frequency of blood glucose levels falling below a predefined threshold, typically \<3.9 mmol/L, during a specified monitoring period. It reflects how often hypoglycemic events occur in relation to the total monitoring time or number of patients monitored.
Blood Glucose Variability (IQR)	2 years	The 25th and 75th percentile values of blood glucose fluctuations (Interquartile Range, IQR).

Trial Locations

Locations (1)

Shanxi Bethune Hospital; 🇨🇳 Taiyuan, Shanxi, China