Clinical Trial

Relieving Carb Counting Via Flexible-userinteraction Multiple-input Control Architectures

Study acronym: FLEX-AP
Not Yet Recruiting
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Record status
This record was last updated June 22, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
Developing algorithms for Automated Insulin Delivery (AID) systems that alleviate the burden of meal announcements, culminating in the FLEX-AP system. This fully automated artificial pancreas system is designed to operate without meal or exercise announcements while allowing for optional user input. FLEX-APaims to achieve a balance between glycemic control and user quality of life by incorporating user preferences into its operation. The FLEX-AP system features a flexible control architecture tailored to handle unannounced meals and exercise. It also allows for optional meal announcements and offers guidance for mitigating hypoglycemia, such as counterregulatory actions like rescue carbohydrate intake for patients who prefer it. The proposed benefit of FLEX-AP is to improve glycemic control while respecting individual preferences, which sets it apart from existing AID systems.
Trial Details
NCT Number NCT07031492
Lead Sponsor Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators: Universitat Politècnica de València
Conditions T1DM - Type 1 Diabetes Mellitus
Enrollment 10 participants
Start Date 2025-09
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-06-22