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

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

August 31, 2027

Conditions
Latent Autoimmune Diabetes in Adults (LADA)
Interventions
OTHER

Hybrid Closed-Loop Artificial Pancreas System

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).

Trial Locations (1)

030000

RECRUITING

Shanxi Bethune Hospital, Taiyuan

All Listed Sponsors
lead

Shanxi Bethune Hospital

OTHER