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NCT06941675

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

Sponsor: Shanxi Bethune Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-04-01

Completion Date

2027-08-31

Last Updated

2025-04-24

Healthy Volunteers

Conditions

Latent Autoimmune Diabetes in Adults (LADA)

Interventions

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).

Inclusion Criteria: 1. Age between 18 and 70 years old. 2. Meet the diagnostic criteria for LADA in the "Chinese Expert Consensus on the Diagnosis and Treatment of Latent Autoimmune Diabetes in Adults (2021 Edition)": * 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. 3. Patients are able to correctly use insulin pumps and CGM devices and have a certain learning ability and operational ability. 4. Baseline HbA1c \> 7.0% or HbA1c \> 6.0% combined with hypoglycemia. 5. Patients agree to participate in the study and sign the informed consent form. Exclusion Criteria: 1. The patient has been clearly diagnosed with type 2 diabetes or special types of diabetes. 2. The patient has experienced acute diabetic complications within the past 1 month, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc. 3. The patient has severe symptoms of hypoglycemia intolerance. 4. The patient has skin diseases such as rashes and prurigo, or abnormal coagulation function. 5. The patient has diseases related to impaired glucose metabolism, such as uncontrolled hyperthyroidism, hypothyroidism, Cushing's syndrome, etc. 6. The patient has comorbid severe liver, kidney, gastrointestinal, hematological, brain, circulatory system diseases, etc. 7. The patient has other severe chronic diseases (such as malignant tumors, end-stage organ failure, etc.). 8. The patient has impaired consciousness or mental illness, lacks self-control, and cannot express clearly. 9. Lactating women, pregnant women, or women who plan to become pregnant during the trial period. 10. The patient is currently using or has used glucocorticoids or other drugs that interfere with glucose metabolism within 1 month before screening. 11. The patient is allergic to the drugs involved in the clinical diagnosis and treatment plan. 12. The patient is currently using other closed-loop systems. 13. People who are not suitable for conventional insulin pump treatment and those with contraindications. 14. The patient is known or suspected to have an insulin-allergic constitution and is allergic to adhesive tape, insulin pumps, or CGM devices. Other situations where the researcher deems the patient unfit to participate in the clinical trial.

Locations (1)

Shanxi Bethune Hospital

Taiyuan, Shanxi, China