Hybrid Closed-Loop System in LADA Patients: A Randomized Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanxi Bethune Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age between 18 and 70 years old.

The onset age of diabetes is ≥ 18 years old.

Positive for islet autoantibodies or islet autoimmunity T cells.

Do not rely on insulin therapy for at least 6 months after the diagnosis of diabetes.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Hybrid Closed-Loop Artificial Pancreas System

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators