Application of a Hybrid Closed-Loop Artificial Pancreas System in Patients With Diabetes After Kidney Transplantation: An Open-Label, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Shanxi Bethune Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Days Required to Achieve 70% TIR
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Conventional Insulin Pump and CGM Group
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.
Intervention: Hybrid Closed-Loop Artificial Pancreas System (Other)
Hybrid Closed-Loop Artificial Pancreas with CGM Group
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.
Intervention: Hybrid Closed-Loop Artificial Pancreas System (Other)
Outcomes
Primary Outcomes
Days Required to Achieve 70% TIR
Time Frame: 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.
Time Frame: 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 Outcomes
- 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)