NCT06941675 Hybrid Closed-Loop System in LADA Patients: A Randomized Trial
| NCT ID | NCT06941675 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanxi Bethune Hospital |
| Condition | Latent Autoimmune Diabetes in Adults (LADA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-04-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06941675 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Latent Autoimmune Diabetes in Adults (LADA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06941675 currently recruiting?
Yes, NCT06941675 is actively recruiting participants. Contact the research team at lswspring6@aliyun.com for enrollment information.
Where is the NCT06941675 trial being conducted?
This trial is being conducted at Taiyuan, China.
Who is sponsoring the NCT06941675 clinical trial?
NCT06941675 is sponsored by Shanxi Bethune Hospital. The trial plans to enroll 50 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.