Actively Recruiting
Hybrid Closed-Loop System in LADA Patients: A Randomized Trial
Led by Shanxi Bethune Hospital · Updated on 2025-04-24
50
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Based on the difficulties in blood glucose control among the Latent Autoimmune Diabetes in Adults (LADA) population and the deficiencies of previous studies, this research aims to conduct a clinical comparative study. The short-term blood glucose control effects of the closed-loop system and the combination of a conventional insulin pump and Continuous Glucose Monitoring (CGM) in hospitalized LADA patients will be evaluated to explore the clinical application value of these methods in LADA patients. Moreover, this study aims to provide a more precise and personalized blood glucose management plan for LADA patients. As a slowly progressive subtype of autoimmune type 1 diabetes mellitus (T1DM), LADA patients have significant differences in pathological characteristics, clinical needs, and treatment effects compared with classical T1DM patients. However, they also face huge challenges in blood glucose management. This study will focus on LADA patients for the first time, especially the group of hospitalized patients, to fill the gap in this field. Meanwhile, by introducing the cutting-edge closed-loop system technology, it will provide new ideas and solutions for the clinical blood glucose management of LADA patients. Through a comparative analysis of the short-term blood glucose control effects of the closed-loop system and the combination of a conventional insulin pump and CGM, this study aims to provide more precise and personalized treatment strategies for LADA patients and promote the further development of diabetes treatment technologies.
CONDITIONS
Official Title
Hybrid Closed-Loop System in LADA Patients: A Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Diagnosed with LADA according to Chinese Expert Consensus (2021), including onset age ≥ 18, positive islet autoantibodies or autoimmunity T cells
- Not dependent on insulin therapy for at least 6 months after diagnosis
- Able to correctly use insulin pumps and CGM devices with sufficient learning and operational ability
- Baseline HbA1c greater than 7.0% or HbA1c greater than 6.0% combined with hypoglycemia
- Agree to participate and sign informed consent
You will not qualify if you...
- Diagnosed with type 2 diabetes or special types of diabetes
- Experienced acute diabetic complications within the past month (e.g., diabetic ketoacidosis, hyperglycemic hyperosmolar coma)
- Severe hypoglycemia intolerance
- Skin diseases like rashes or prurigo, or abnormal blood clotting
- Diseases affecting glucose metabolism such as uncontrolled thyroid disorders or Cushing's syndrome
- Severe liver, kidney, gastrointestinal, blood, brain, or circulatory system diseases
- Other severe chronic diseases like malignant tumors or end-stage organ failure
- Impaired consciousness or mental illness preventing clear expression or self-control
- Pregnant, breastfeeding, or planning pregnancy during the trial
- Using or recently used glucocorticoids or drugs affecting glucose metabolism within one month
- Allergic to drugs involved in diagnosis or treatment plan
- Currently using other closed-loop systems
- Unsuitable for conventional insulin pump treatment or with contraindications
- Known or suspected allergies to insulin, adhesive tape, pumps, or CGM devices
- Other conditions deemed unsuitable by researchers
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
Research Team
S
Shiwei Liu, Doctor's degree
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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