Hybrid Closed-Loop System in LADA Patients: A Randomized Trial

Not Applicable

Recruiting

• Conditions: Latent Autoimmune Diabetes in Adults (LADA)

• Registration Number: NCT06941675
• Lead Sponsor: Shanxi Bethune Hospital

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-27
• Study Start: 2025-04-01
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Primary Completion: 2027-06-30
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time required to achieve 70% TIR	2 years	Time in Range (TIR) refers to the percentage of time that blood glucose levels are within the target range of 3.9 to 10.0 mmol/L. The calculation formula is: TIR = (Time within the target range / Total time) × 100%
TIR achievement rate after 5 days of treatment	5 days	Time in Range (TIR) refers to the percentage of time that blood glucose levels are within the target range of 3.9 to 10.0 mmol/L. The calculation formula is: TIR = (Time within the target range / Total time) × 100%

Secondary Outcome Measures

Name	Time	Method
Blood Glucose Control Rate	2 years	The criteria for blood glucose target achievement are as follows: fasting blood glucose should be controlled within 4.0 - 7.0 mmol/L, postprandial blood glucose within 5.0 - 10.0 mmol/L, and blood glucose before going to bed within 4.4 - 7.8 mmol/L. The rate of blood glucose target achievement within 1 week of intensive insulin therapy will be statistically analyzed. The calculation formula is: Rate of blood glucose target achievement = (Number of patients achieving blood glucose targets / Total number of patients) × 100%
Time Below Range (TBR)、Time Above Range (TAR)	2 years	Time below the blood glucose target range, which is the percentage of time that blood glucose is below the target range of 3.9 mmol/L. The calculation formula is: TBR = (Time when blood glucose \< 3.9 mmol/L in the target range / Total time) × 100%.; Time above the blood glucose target range, which is the percentage of time that blood glucose is above the target range of 10.0 mmol/L. The calculation formula is: TAR = (Time when blood glucose \> 10.0 mmol/L in the target range / Total time) × 100%.
Hypoglycemia Incidence Rate	2 years	The diagnostic criterion for hypoglycemia is a blood glucose level of 3.0 - 3.9 mmol/L. The hypoglycemia incidence rates during the treatment process in the two groups will be counted and compared. The diagnostic criterion for severe hypoglycemia is a blood glucose level \< 3.0 mmol/L. The severe hypoglycemia incidence rates during the treatment process in the two groups will be counted and compared.
Inter-quartile Range (IQR) of Blood Glucose	2 years	The 25th and 75th percentile values of the blood glucose fluctuation range (inter - quartile range, IQR).
Average Daily Insulin Dosage	2 years	During the calculation period, record the specific dose of each injection every day.
Adverse Event	2 years	Count and compare the incidences of adverse events and serious adverse events during the treatment process between the two groups.

Trial Locations

Locations (1)

Shanxi Bethune Hospital; 🇨🇳 Taiyuan, Shanxi, China