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.
Aged 18-60 years inclusive.
T1D as per the American Diabetes Association classification for >12 months prior to the screening visit.
Minimed 780G®-hybrid closed-loop system users for at least 6 months. Use of automatic mode (Smartguard) > 80% of the time.
A1c level below 9.0% at Screening visit.
Not having met the previous criteria for inclusion.
Females who are pregnant or intend to become pregnant during the study period; a positive pregnancy test at screening will result in exclusion.
Breastfeeding.
Use of any non-insulin glucose-lowering therapy within three months prior to study initiation.
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead sponsor
Universitat Politècnica de València
Collaborator