Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06962410

Hybrid Closed-Loop in Diabetes Post-Kidney Transplant: A Randomized Trial

Led by Shanxi Bethune Hospital · Updated on 2025-05-08

30

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Hybrid Closed-Loop in Diabetes Post-Kidney Transplant: A Randomized Trial

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 - 70 years
  • Diagnosed with diabetes according to the "Guidelines for Prevention and Control of Diabetes in China (2024 Edition)"
  • Able to correctly use insulin pumps and continuous glucose monitoring devices
  • Willing to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Experienced acute diabetic complications such as diabetic ketoacidosis or hyperglycemic hyperosmolar coma within the past month
  • Severe symptoms of hypoglycemic intolerance
  • Skin diseases like rashes, prurigo, or abnormal blood clotting
  • Diseases affecting glucose metabolism like uncontrolled hyperthyroidism, hypothyroidism, or Cushing's syndrome
  • Severe liver, kidney, gastrointestinal, blood, brain, or circulatory system diseases
  • Malignant tumors including solid or blood cancers
  • Impaired consciousness, mental illness, or inability to communicate clearly
  • Lactating or pregnant women, or women planning pregnancy during the trial
  • Allergic to drugs involved in the study
  • Currently using other closed-loop systems
  • Not suitable for conventional insulin pump therapy or have contraindications
  • Known or suspected allergy to insulin, adhesive tape, insulin pumps, or CGM devices
  • Other conditions deemed unfit by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Shanxi Bethune Hospital

Taiyuan, Shanxi, China, 030000

Actively Recruiting

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Research Team

S

Shiwei Liu, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Hybrid Closed-Loop in Diabetes Post-Kidney Transplant: A Randomized Trial | DecenTrialz