Status:
RECRUITING
Hybrid Closed-Loop System in LADA Patients: A Randomized Trial
Lead Sponsor:
Shanxi Bethune Hospital
Conditions:
Latent Autoimmune Diabetes in Adults (LADA)
Eligibility:
All Genders
18-70 years
Phase:
NA
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 c...
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 (LA...
Eligibility Criteria
Inclusion
- Age between 18 and 70 years old.
- 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.
- Patients are able to correctly use insulin pumps and CGM devices and have a certain learning ability and operational ability.
- Baseline HbA1c \> 7.0% or HbA1c \> 6.0% combined with hypoglycemia.
- Patients agree to participate in the study and sign the informed consent form.
Exclusion
- 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.
- The patient has diseases related to impaired glucose metabolism, such as uncontrolled hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
- The patient has comorbid severe liver, kidney, gastrointestinal, hematological, brain, circulatory system diseases, etc.
- The patient has other severe chronic diseases (such as malignant tumors, end-stage organ failure, etc.).
- The patient has impaired consciousness or mental illness, lacks self-control, and cannot express clearly.
- Lactating women, pregnant women, or women who plan to become pregnant during the trial period.
- The patient is currently using or has used glucocorticoids or other drugs that interfere with glucose metabolism within 1 month before screening.
- The patient is allergic to the drugs involved in the clinical diagnosis and treatment plan.
- The patient is currently using other closed-loop systems.
- People who are not suitable for conventional insulin pump treatment and those with contraindications.
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06941675
Start Date
April 1 2025
End Date
August 31 2027
Last Update
April 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000