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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Contact Information
Primary
Shiwei Liu, Doctor's degree
lswspring6@aliyun.com
+86 13191072733
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 50
Treatments
Experimental: Hybrid Closed-Loop Artificial Pancreas System with CGM Group
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.
Placebo_comparator: Conventional Insulin Pump Combined with CGM Group
\*\*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.\*\*
Related Therapeutic Areas
Sponsors
Leads: Shanxi Bethune Hospital

This content was sourced from clinicaltrials.gov