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

NCT06941675 | Recruiting

• 1 other identifier: YXLL-2025-082
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Latent Autoimmune Diabetes in Adults (LADA)

Outcome Measures

Primary Outcomes (2)

• Time required to achieve 70% TIR

  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%

  2 years

• TIR achievement rate after 5 days of treatment

  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%

  5 days

Secondary Outcomes (6)

• Blood Glucose Control Rate

  2 years

• Time Below Range (TBR)、Time Above Range (TAR)

  2 years

• Hypoglycemia Incidence Rate

  2 years

• Inter-quartile Range (IQR) of Blood Glucose

  2 years

• Average Daily Insulin Dosage

  2 years

Study Arms (2)

Hybrid Closed-Loop Artificial Pancreas System with CGM Group

EXPERIMENTAL

This group uses an open-source hybrid closed-loop artificial pancreas system with ultra-rapid-acting insulin (Novo Nordisk, Denmark). Daily insulin needs are calculated based on weight (0.3-0.6U/kg/day) \& adjusted by the system. Physicians provide bolus instructions, entered by nurses. CGM \& daily finger pricks are used for monitoring \& calibration. The system predicts \& prevents hypoglycemia, halting insulin when BG ≤ 4.4mmol/L. An alarm alerts for BG \<3.9mmol/L.

Other: Hybrid Closed-Loop Artificial Pancreas System

Conventional Insulin Pump Combined with CGM Group

PLACEBO COMPARATOR

\*\*According to the patient's weight, the total daily insulin requirement is calculated at a rate of 0.3 - 0.6 U/(kg·d) and distributed to pre-meal administrations based on the patient's specific condition. Blood glucose is monitored using a continuous glucose monitoring system in combination with daily fingerstick capillary blood glucose measurements (fasting blood glucose, and blood glucose 2 hours after breakfast, lunch, and dinner, for a total of 4 measurements). Insulin dosage is adjusted according to the patient's blood glucose levels until the blood glucose reaches the target level.\*\*

Other: Hybrid Closed-Loop Artificial Pancreas System

Interventions

Hybrid Closed-Loop Artificial Pancreas System OTHER

Hybrid Closed-Loop Artificial Pancreas System Group: Uses an open-source system with Novo Nordisk ultra-rapid-acting insulin (approval: J20050097, 3 mL: 300 U). Daily insulin dose calculated at 0.3-0.6 U/(kg\*d) based on weight; system auto-adjusts basal rate. Physicians prescribe bolus doses, entered by nurses via AAPS software. Glucose correction uses CGM + 4 daily capillary tests (fasting, 2h post-meal). AAPS features hypoglycemia prediction suspend (pauses basal if glucose ≤4.4 mmol/L, resumes upon recovery) and alarms (\<3.9 mmol/L, ensures nighttime alert).

Conventional Insulin Pump Combined with CGM Group; Hybrid Closed-Loop Artificial Pancreas System with CGM Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanxi Bethune Hospital: lead

Study Sites (1)

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

MeSH Terms

Conditions

Latent Autoimmune Diabetes in Adults

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Shiwei Liu, Doctor's degree

CONTACT

+86 13191072733; lswspring6@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 24, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)