Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose Target Achievement Rate (TAR) | 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%. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiwei Liu, Doctor | Contact | +86 13191072733 | 0351-2170956 | lswspring6@aliyun.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanxi Bethune Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
If there is a need to use data, please contact the person in charge and follow the relevant procedures to achieve data sharing. Without permission, do not use the data directly.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 2 years |
| Time Below Range (TBR) ，Time Above Range (TAR) | 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%. | 2 years |
| Hypoglycemia incidence | 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. | 2 years |
| Blood Glucose Variability (IQR) | The 25th and 75th percentile values of blood glucose fluctuations (Interquartile Range, IQR). | 2 years |