AI-Assisted Remote Insulin Pump Optimization in T1DM
NCT07732777 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-07-29
Summary
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.
Conditions
- Type 1 Diabetes Mellitus
- Type 1 Diabetes (T1D)
Interventions
- DEVICE
-
AI-Assisted Insulin Pump Settings Optimization System
A cloud-based software system that analyzes continuous glucose monitoring and insulin pump data to generate recommendations for optimizing insulin pump settings. All recommendations are reviewed and approved by a physician prior to implementation.
- DEVICE
-
Conventional Insulin Pump Therapy
Sensor-augmented insulin pump therapy using continuous glucose monitoring with dose adjustments made by the participant and/or physician per standard clinical practice, without AI-assisted algorithmic recommendations.
Sponsors & Collaborators
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 14 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-28
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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