Comparing blood glucose management methods in LADA patients

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

This study is testing whether a new artificial pancreas system can manage blood sugar better than a traditional insulin pump with continuous monitoring for people with Latent Autoimmune Diabetes in Adults (LADA) who are in the hospital.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanxi Bethune Hospital (Academic / other)
• Locations: 1 site (Taiyuan, Shanxi)
• Trial ID: NCT06941675 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a hybrid closed-loop artificial pancreas system compared to a traditional insulin pump combined with Continuous Glucose Monitoring (CGM) in hospitalized patients with Latent Autoimmune Diabetes in Adults (LADA). Conducted at Shanxi Bethune Hospital, the study will enroll 50 LADA patients and randomly assign them to one of the two treatment groups after their admission. The trial will monitor blood glucose levels over a series of 24-hour periods to assess the short-term control effects of each method. The goal is to provide a more personalized blood glucose management plan tailored to the unique needs of LADA patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 diagnosed with LADA who can use insulin pumps and CGM devices.

Not a fit: Patients with a clear diagnosis of type 2 diabetes or those who have experienced acute diabetic complications recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved blood glucose control and management strategies for LADA patients.

How similar studies have performed: While studies on closed-loop systems have shown promise in other diabetes populations, this specific approach in LADA patients is novel and untested.

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.

Where this trial is running

Taiyuan, Shanxi

• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)

Study contacts

• Study coordinator: Shiwei Liu, Doctor's degree

Conditions Latent Autoimmune Diabetes in Adults