NCT06941675

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

Application of a Hybrid Closed-Loop Artificial Pancreas System in Patients With Latent Autoimmune Diabetes in Adults (LADA): An Open-Label, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanxi Bethune Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study aims to compare the clinical effects of a hybrid closed-loop artificial pancreas system and a traditional insulin pump in hospitalized patients with Latent Autoimmune Diabetes in Adults (LADA) through a single-center, open-label, randomized controlled trial. Referring to the designs of similar clinical trials, the number of cases in each group of this study is determined to be 25, with a total of 50 cases. The study subjects are LADA patients hospitalized in the Department of Endocrinology of Shanxi Bethune Hospital from April 2025 to April 2027. The study design is as follows: Starting from the second 24-hour period after the patient's admission, with each subsequent 24-hour period as a monitoring unit, after collecting baseline data, the patients are randomly divided into two groups: the closed-loop system group and the control group. The closed-loop system group uses a hybrid closed-loop artificial pancreas system combined with Continuous Glucose Monitoring (CGM), while the control group continues to use a traditional insulin pump combined with CGM. During the study, both groups wear CGM devices for continuous monitoring, and relevant clinical data are collected during and after the treatment for statistical analysis to compare the short-term blood glucose control effects of the two intensive insulin treatment regimens in hospitalized LADA patients.

Conditions

• Latent Autoimmune Diabetes in Adults (LADA)

Interventions

Type	Name	Description
OTHER	Hybrid Closed-Loop Artificial Pancreas System	Hybrid Closed-Loop Artificial Pancreas System Group: Uses an open-source system with Novo Nordisk ultra-rapid-acting insulin (approval: J20050097, 3 mL: 300 U). Daily insulin dose calculated at 0.3-0.6 U/(kg\*d) based on weight; system auto-adjusts basal rate. Physicians prescribe bolus doses, entered by nurses via AAPS software. Glucose correction uses CGM + 4 daily capillary tests (fasting, 2h post-meal). AAPS features hypoglycemia prediction suspend (pauses basal if glucose ≤4.4 mmol/L, resumes upon recovery) and alarms (\<3.9 mmol/L, ensures nighttime alert).

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-06-30
• Completion: 2027-08-31
• First posted: 2025-04-24
• Last updated: 2025-04-24

Locations

1 site across 1 country: China