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

NCT06962410 | Recruiting

• 1 other identifier: YXLL-2025-027
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Patients With Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

• Days Required to Achieve 70% TIR

  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%.

  2 years

• The blood glucose target achievement rate during 5×24 hours of treatment.

  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.

  2 years

Secondary Outcomes (4)

• Blood Glucose Target Achievement Rate (TAR)

  2 years

• Time Below Range (TBR) ，Time Above Range (TAR)

  2 years

• Hypoglycemia incidence

  2 years

• Blood Glucose Variability (IQR)

  2 years

Study Arms (2)

Conventional Insulin Pump and CGM Group

EXPERIMENTAL

Calculate the total daily insulin requirement based on the patient's weight at a rate of 0.2-0.4 U/（kg·d）, and allocate it to premeal doses according to the patient's specific condition. Monitor blood glucose levels using a continuous glucose monitoring system, combined with five daily capillary blood glucose tests (fasting, 2 hours after breakfast, 2 hours after lunch, 2 hours after dinner, and before bedtime). Adjust the insulin dosage according to the patient's blood glucose levels until the target range is achieved.

Other: Hybrid Closed-Loop Artificial Pancreas System

Hybrid Closed-Loop Artificial Pancreas with CGM Group

PLACEBO COMPARATOR

The hybrid closed-loop artificial pancreas group: An open-source hybrid closed-loop system was used with ultra-short-acting insulin (Novo Nordisk A/S, Denmark; Approval No.: J20050097; Spec.: 3 mL: 300 U). The total daily insulin dose was calculated at 0.2-0.4 U/(kg·d) based on patient weight. The system automatically adjusted the basal rate based on blood glucose levels. Physicians prescribed bolus doses based on prior experience and glucose readings, which nurses manually entered into the AAPS software. Continuous glucose monitoring (CGM) was used, with five daily fingerstick capillary blood glucose tests for correction (fasting, 2 hours post-breakfast, lunch, dinner, and before sleep). The AAPS system had a low glucose prediction suspend feature, pausing basal infusion when glucose was predicted to drop below 4.4 mmol/L until it returned to a safe range. An alarm threshold was set at \<3.9 mmol/L with a loud volume to awaken patients during deep sleep.

Other: Hybrid Closed-Loop Artificial Pancreas System

Interventions

Hybrid Closed-Loop Artificial Pancreas System OTHER

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.

Conventional Insulin Pump and CGM Group; Hybrid Closed-Loop Artificial Pancreas with CGM Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanxi Bethune Hospital: lead

Study Sites (1)

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

Central Study Contacts

Shiwei Liu, Doctor

CONTACT

+86 13191072733; lswspring6@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 8, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)