Hybrid Closed-Loop in Diabetes Post-Kidney Transplant: A Randomized Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanxi Bethune Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Hybrid Closed-Loop Artificial Pancreas System
Other interventionThe 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Conventional Insulin Pump and CGM GroupExperimental treatment 1 intervention
Group B: Hybrid Closed-Loop Artificial Pancreas with CGM GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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%.
Time frame
2 years2
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.
Time frame
2 yearsSecondary outcomes
1
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%.
Time frame
2 years2
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%.
Time frame
2 years3
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.
Time frame
2 years4
Blood Glucose Variability (IQR)
The 25th and 75th percentile values of blood glucose fluctuations (Interquartile Range, IQR).
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov