Hybrid Closed-Loop System in LADA Patients: A Randomized 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 conven
| Condition(s) | Latent Autoimmune Diabetes in Adults (LADA) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 tr |
| Who can participate | 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 type |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Shanxi Bethune Hospital |
| Locations | Taiyuan, Shanxi, China |
| Start date | 2025-04-01 |
| NCT ID | NCT06941675 |
| Official listing | https://clinicaltrials.gov/study/NCT06941675 |