Hybrid Closed-Loop System in LADA Patients: A Randomized Trial (NCT06941675) | Clinical Trial Compass
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Hybrid Closed-Loop System in LADA Patients: A Randomized Trial
China50 participantsStarted 2025-04-01
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age between 18 and 70 years old.
✓. Meet the diagnostic criteria for LADA in the "Chinese Expert Consensus on the Diagnosis and Treatment of Latent Autoimmune Diabetes in Adults (2021 Edition)":
✓. Patients are able to correctly use insulin pumps and CGM devices and have a certain learning ability and operational ability.
✓. Baseline HbA1c \> 7.0% or HbA1c \> 6.0% combined with hypoglycemia.
✓. Patients agree to participate in the study and sign the informed consent form.
Exclusion criteria
✕. The patient has been clearly diagnosed with type 2 diabetes or special types of diabetes.
✕. The patient has experienced acute diabetic complications within the past 1 month, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.
✕. The patient has severe symptoms of hypoglycemia intolerance.
✕. The patient has skin diseases such as rashes and prurigo, or abnormal coagulation function.