Status:
RECRUITING
Hybrid Closed-Loop in Diabetes Post-Kidney Transplant: A Randomized Trial
Lead Sponsor:
Shanxi Bethune Hospital
Conditions:
Diabetes Mellitus Patients With Kidney Transplantation
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
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 comparat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06962410
Start Date
April 1 2025
End Date
August 31 2027
Last Update
May 8 2025
Active Locations (1)
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1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000