Clinical trial NCT06941675: Hybrid Closed-Loop System in LADA Patients: A Randomized Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Latent Autoimmune Diabetes in Adults (LADA)
Lead sponsor: Shanxi Bethune Hospital
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 (LADA) through a single-center, open-label, randomized controlled trial. Referring to the designs of similar clinical trials, the number of cases in each group of this study is determined to be 25, with a total of 50 cases. The study subjects are LADA patients hospitalized in the Department of Endocrinology of Shanxi Bethune Hospital from April 2025 to April 2027. The study design is as follows: Starting from the second 24-hour period after the patient's admission, with each subsequent 24-hour period as a monitoring unit, after collecting baseline data, the patients are randomly divided into two groups: the closed-loop system group and the control group. The closed-loop system group uses a hybrid closed-loop artificial pancreas system combined with Continuous Glucose Monitoring (CGM), while the control group continues to use a traditional insulin pump combined with CGM. During the study, both groups wear CGM devices for continuous monitoring, and relevant clinical data are collected during and after the treatment for statistical analysis to compare the short-term blood glucose control effects of the two intensive insulin treatment regimens in hospitalized LADA patients.

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.

Primary outcomes:
measure: Time required to achieve 70% TIR
timeFrame: 2 years
measure: TIR achievement rate after 5 days of treatment
timeFrame: 5 days
Secondary outcomes:
measure: Blood Glucose Control Rate
timeFrame: 2 years
measure: Time Below Range (TBR)、Time Above Range (TAR)
timeFrame: 2 years
measure: Hypoglycemia Incidence Rate
timeFrame: 2 years
measure: Inter-quartile Range (IQR) of Blood Glucose
timeFrame: 2 years
measure: Average Daily Insulin Dosage
timeFrame: 2 years
measure: Adverse Event
timeFrame: 2 years
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
Study officials:
References: