50
Participants
Start Date
April 1, 2025
Primary Completion Date
June 30, 2027
Study Completion Date
August 31, 2027
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).
RECRUITING
Shanxi Bethune Hospital, Taiyuan
Shanxi Bethune Hospital
OTHER