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.
Single group
FLEX-AP system will be implemented to T1D patients
DeviceA FLEX-AP system will be implemented to T1D patients after they have been given a Minimed 780G hybrid closed-loop system
Efficacy of the FLEX-AP system
Percentage of time spent in target sensor glucose range (70-180 mg/dL, Time in range (TIR)) during the FLEX-AP controlled ambulatory phase in Automatic mode.
Safety of the FLEX-AP system
To assess the safety of the FLEX-AP system in a controlled ambulatory setting simulating real-life conditions:Number of symptomatic hypoglycemia events, Number of severe hypoglycemia events, Episodes of diabetic ketoacidosis (DKA) or ketosis, Technical issues related to the insulin pump and dermatological issues related to device use.
Continuous glucose monitoring (CGM) data during the FLEX-AP controlled ambulatory phase in automatic mode will be analyzed according to the following standardized CGM metrics for clinical trials.
1\) Percentage of participants able to maintain TIR\>70% (70-180 mg/dL). This outcome will be calculated for two time periods: 1) daytime (06:00 - 23:59 hours), and 2) nighttime (00:00 - 05:59 hours).
Continuous glucose monitoring (CGM) data during the FLEX-AP controlled ambulatory phase in automatic mode will be analyzed according to the following standardized CGM metrics for clinical trials.
2\) TIR, defined as % CGM time 70-140 mg/dL. This outcomes will be calculated for two time periods: 1) daytime (06:00 - 23:59 hours), and 2) night time (00:00 - 05:59 hours).
Continuous glucose monitoring (CGM) data during the FLEX-AP controlled ambulatory phase in automatic mode will be analyzed according to the following standardized CGM metrics for clinical trials.
3\) % CGM time in Level 1 hypoglycemia (CGM \<70 mg/dL and \> 54 mg/dL). This outcomes will be calculated for two time periods: 1) daytime (06:00 - 23:59 hours), and 2) night time (00:00 - 05:59 hours).
Continuous glucose monitoring (CGM) data during the FLEX-AP controlled ambulatory phase in automatic mode will be analyzed according to the following standardized CGM metrics for clinical trials.
4\) % CGM time in Level 2 hypoglycemia (CGM ≤ 54 mg/dL). This outcome will be calculated for two time periods: 1) daytime (06:00 - 23:59 hours), and 2) night time (00:00 - 05:59 hours).
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead sponsor
Universitat Politècnica de València
Collaborator
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