Hybrid Closed-Loop in Diabetes Post-Kidney Transplant: A Randomized Trial
NCT ID: NCT06962410
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-04-01
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Hybrid Closed-Loop Artificial Pancreas System
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.
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.
Hybrid Closed-Loop Artificial Pancreas System
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.
Interventions
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Hybrid Closed-Loop Artificial Pancreas System
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Shanxi Bethune Hospital
OTHER
Responsible Party
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Locations
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Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YXLL-2025-027
Identifier Type: -
Identifier Source: org_study_id
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