This study evaluates an AI-assisted remote parameter optimization tool for individuals with type 1 diabetes (T1D) using insulin pump and continuous glucose monitoring (CGM). The Artificial Intelligence (AI) algorithm analyzes regularly CGM and insulin data to generate personalized recommendations for adjusting pump settings. All algorithm-generated recommendations are reviewed and approved by physicians before being transmitted to the participant's mobile application for implementation.
Inclusion Criteria:
Clinical diagnosis of T1D, meeting all three of the following criteria:
Age 14 to 65 years, inclusive, male or female.
HbA1c < 11.0% at the screening visit.
At least 3 months of documented T1D duration, and at least 3 months of treatment with either multiple daily insulin injections (MDI) or insulin pump therapy.
Willing to wear the study device continuously throughout the trial and to use either insulin aspart or insulin lispro.
Willing to perform at least one fingerstick blood glucose measurement per day.
Willing to upload data from the study device.
Willing and able to provide signed informed consent (by the participant and/or legally authorized representative) and to learn basic diabetes management and study device operation.
Exclusion Criteria:
lujingsnow@126.com0086-025-83106666-61431
During the inpatient stay, the AI-assisted decision support system will analyze continuous glucose monitoring and insulin pump data to generate daily recommendations for optimizing insulin dosage. All algorithm-generated recommendations will be reviewed and approved by physicians before implementation.
Participants in this arm will complete a home-based crossover trial. In the first 4-week period, they will receive AI-assisted remote optimization of insulin pump settings. The AI algorithm will analyze weekly uploaded CGM and insulin data to generate parameter adjustment recommendations, which will be reviewed and approved by a physician prior to remote transmission to the participant's mobile app. In the second 4-week period, they will switch to conventional pump therapy without AI-assisted recommendations.
Participants in this arm will complete a home-based crossover trial. In the first 4-week period, they will receive conventional pump therapy without AI-assisted recommendations In the second 4-week period, they will cross over to receive AI-assisted remote optimization of insulin pump settings. The AI algorithm will analyze weekly uploaded CGM and insulin data to generate parameter adjustment recommendations, which will be reviewed and approved by a physician prior to remote transmission to the participant's mobile app.