Periodic Reporting for period 2 - FORGETDIABETES (A BIONIC INVISIBLE PANCREAS TO FORGET DIABETES)
Periodo di rendicontazione: 2022-04-01 al 2023-09-30
The last decade has seen important developments in closed‐loop subcutaneous (sc) sensing and insulin delivery closed‐loop systems. However major limitations of subcutaneous insulin delivery still exist, including the hyper‐insulinemia due to the non‐physiologic sc route and need for meal announcement. FORGETDIABETES introduces a radically new approach to Type 1 Diabetes (T1D) treatment, by developing a fully‐implantable, fully‐automated bionic invisible pancreas (BIP) based on physiological intraperitoneal (ip) hormone delivery, thus enabling an optimal glycemic control. BIP will free individuals with T1D from therapeutic actions and from the related psychological burden. BIP will become a life‐condition (like contact lens), allowing T1D patients to live just as everybody else. An interdisciplinary team with top experts in micronano mechatronics, control engineering, biomaterials, endocrinology, surgery and behavioral sciences has been assembled to develop a long‐lasting system relying on a physiological glucose sensing and hormone delivery, orchestrated by personalized adaptive algorithms with advanced self‐diagnostic capabilities. Pump refilling through a weekly oral recyclable drug pill will free T1D subjects from the burden of treatment actions. Wireless power transfer and data transmission to cloud‐based data management system round‐up to a revolutionary treatment device for this incurable chronic disease. In this project, the key technologies enabling BIP will be developed. Furthermore, extensive in vivo preclinical experiments along with massive in silico testing will establish the prototype system, paving the way to the ambitious first‐in‐human inpatient trial of BIP. This paradigm will revolutionize diabetes treatment and stimulate an innovation ecosystem including research bodies, SMEs, patient organizations, diabetes societies and clinicians.
During the first 18 months of the project we have successfully achieved three goals:
1. development of the prototype implantable pump for intraperitoneal insulin delivery.
2. development of the prototype implantable sensor for intraperitoneal glucose sensing
3. development of the control algorithm for the ip insulin delivery and the in silico simulation tool to test ip controller.
These are the three essential components of the BIP system that will be tested in vivo in the animal model over the next year. Component connectivity and bench safety tests are ongoing.
During the second Reporting Period we have pursued the following objectives:
1. the intraperitoneal (IP) implantable delivery system (WP1)
2. the IP sensor (WP2)
3. the porting of the control algorithm (WP3)
4. the preclinical testing of BIP components (IP sensor and pump) (WP4)
5. the evaluation of human factors involved in system development (WP5)
6. the bench testing of BIP (WP6)
1. development of the prototype implantable pump for intraperitoneal insulin delivery.
2. development of the prototype implantable sensor for intraperitoneal glucose sensing
3. development of the control algorithm for the ip insulin delivery and the in silico simulation tool to test ip controller.
These are the three essential components of the BIP system that will be tested in vivo in the animal model over the next year. Component connectivity and bench safety tests are ongoing.
During the second Reporting Period we have pursued the following objectives:
1. the intraperitoneal (IP) implantable delivery system (WP1)
2. the IP sensor (WP2)
3. the porting of the control algorithm (WP3)
4. the preclinical testing of BIP components (IP sensor and pump) (WP4)
5. the evaluation of human factors involved in system development (WP5)
6. the bench testing of BIP (WP6)
The proposal is expected to provide a device prototype by the end of the project (TRL3/4) that will require further industrial development to reach a higher TRL. The BIP is expected to change diabetes treatment by shifting the paradigm form classical subcutaneous insulin delivery to intraperitoneal delivery. Each component is susceptible of further implementation with an expected time-line bench-to-market of 10 years.