A BIONIC INVISIBLE PANCREAS TO FORGET DIABETES

Informazioni relative al progetto

FORGETDIABETES

ID dell’accordo di sovvenzione: 951933

DOI

10.3030/951933

Progetto chiuso

Data della firma CE 28 Maggio 2020

Data di avvio 1 Ottobre 2020

Data di completamento 30 Settembre 2025

Finanziato da

• EXCELLENT SCIENCE - Future and Emerging Technologies (FET)

Costo totale

€ 3 901 014,75

Contributo UE

€ 3 901 005,75

Coordinato da

UNIVERSITA DEGLI STUDI DI PADOVA
Italy

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

Open Research Data Pilot (1)

Updated Data Management Plan

DMP will be updated.

Documents, reports (14)

Intraperitoneal T1D simulator

The intraperitoneal T1D simulator will be developed according to the data available from the preclinical trial and modeled on the framework of the T1D Padova/UVa simulator.

Prelim. report on sensor, control algo and pump bench testing
Project management handbook

Handbook

Online education and training tool

This deliverable is directly related to Task 5.3: Online education and training tools for patients and healthcare professionals to facilitate implementation and increase safety (FIDAM, PSHI) (M6-M48).Education and training tools will be developed that inform patients and healthcare professionals about essential components and functionality of the system and how to deal with problems and system alerts. These training materials will address the following aspects: a) how the system works, b) safety, c) possible indications which patients profit most, d) possible patient characteristics indicating high vulnerability for device-related burden or unsafe use, e) typical barriers of patients and how to address these. These training materials will positively influence the risk-to-benefit ratio of the BIP by providing necessary knowledge and skills to patients and healthcare professionals. Furthermore, unrealistic expectations will be addressed to reduce barriers and burden potentially associated with the system.This deliverable will be in the form of written and graphically designed education material that can be presented and conducted online.

Safety of implantation and ip sensor functionality in pigs

The new system will be tested in pigs after obtaining Ethic committee approval.

In vivo validation of BIP components and full system
Ethical committee approval 1

Ethical committee approval will be filed by CHUM.

Focus Group & human factors identification

This deliverable is directly related to Task 5.1:Semi-structured interviews in different user population subgroupsPatients will be interviewed with regard to potential benefits and barriers for adoption of the new technology. In addition, interviews will focus on human factors associated with successful long-term use as well as on vigilance to ensure early identification of any problems and malfunctions. These interviews will be conducted in three different subgroups with 10 patients with type 1 diabetes per group: (16-75 years, equal gender distribution): 1) Multiple Daily Insulin injection therapy + Continuous Glucose Monitoring (CGM) users 2) Insulin pump + CGM users 3) patients with self-built closed-loop system. For these interviews, mock versions of the charging belt and control unit will be handed to patient to explore their perception and ease of use of those components.Deliverables of this taks will be a report on the outcomes of the focus group discussions and identification of human factors associated with use of BIP.

New questionnaire to assess patient satisfaction

Assessment tool to inform eligibilityThis deliverable is directly related to Task 5.2: Assessment tool to inform eligibility (FIDAM, PSHI) (M11-M48).Selection of most-suited users is a potential strategy to reduce risks associated with the BIP. Based on the interviews, handling of the mock versions, and experiences from the first in-human trials, a possible set of items will be generated depicting important aspects of safe and effective use of the BIP such as perceived barriers and benefits as well as satisfaction. This assessment tool will be validated in adolescent and adult patients either using sensor-augmented pump therapy or “self-built closed-loop systems”. This will allow identification of users most likely to benefit from the BIP and exclude vulnerable patients with high levels of psychological and medical barriers towards an effective and safe use of the BIP.The deliverable will be a questionnaire (assessment tool)

Eligibility criteria & patient emergency card for risk mitigation

This deliverable is directly related to Task 5.4: Ethical implication (FIDAM, PSHI, UNIPD) (M36-M48).The above-mentioned assessment tool as well as the training materials will be integrated in an overall risk mitigation strategy to improve the risk-to-benefit ratio of the BIP. Based on identified human factors, eligibility criteria will be developed or revised for the use of the BIP to reduce risk and harm potentially associated with the new device. Based on human factors results and other experiences during the project, a patient emergency card will be developed that contains safety precautions and instructions in case of device alerts or device-related problems.This deliverable will be a written card for patient.

Fin. reports on each single-exposure experiments
Fin. report on sensor, control algo and pump bench testing
Ethical committee approval
Prelim. report on ip personalized, control algorithm

The algorithm will be developed according to the preliminary data gathered and to the performance of the sensor.

Websites, patent fillings, videos etc. (2)

Fin. project report

final project presentation by website, public conferences, meetings and scientific reports.

Project website

website with project description will be developed

Pubblicazioni

Peer reviewed articles (15)

Kernel-based methods for Volterra series identification

Autori: Alberto Dalla Libera; Ruggero Carli; Gianluigi Pillonetto
Pubblicato in: Automatica, 2021, Pagina/e 1-11, ISSN 0005-1098
Editore: Pergamon Press Ltd.
DOI: 10.1016/j.automatica.2021.109686

<i>In silico</i> design and validation of a time-varying PID controller for an artificial pancreas with intraperitoneal insulin delivery and glucose sensing

Autori: Alberto Dalla Libera, Chiara Toffanin, Martina Drecogna, Alfonso Galderisi, Gianluigi Pillonetto, Claudio Cobelli
Pubblicato in: APL Bioengineering, Numero 7, 2025, ISSN 2473-2877
Editore: AIP Publishing
DOI: 10.1063/5.0145446

Minimal and Maximal Models to Quantitate Glucose Metabolism: Tools to Measure, to Simulate and to Run in Silico Clinical Trials

Autori: Claudio Cobelli; Chiara Dalla Man
Pubblicato in: Journal of Diabetes Science and Technology, 2021, Pagina/e 1-29, ISSN 1932-2968
Editore: Diabetes Technology Society
DOI: 10.1177/19322968211015268

796-P: Perceived Potential Benefits and Barriers for Using a Bionic Invisible Pancreas

Autori: NORBERT HERMANNS, KATHARINA FINKE-GROENE, BERNHARD KULZER, DOMINIC EHRMANN
Pubblicato in: Diabetes, Numero 71, 2022, ISSN 0012-1797
Editore: American Diabetes Association
DOI: 10.2337/db22-796-p

Intraperitoneal Insulin Delivery: Evidence of a Physiological Route for Artificial Pancreas From Compartmental Modeling

Autori: Jorge Lo Presti; Alfonso Galderisi; Francis J. Doyle, III; Howard C. Zisser; Eyal Dassau; Eric Renard; Chiara Toffanin; Claudio Cobelli
Pubblicato in: Journal of Diabetes Science and Technology, 2022, ISSN 1932-2968
Editore: Diabetes Technology Society
DOI: 10.1177/19322968221076559

Comparison between SBMA and MPC coatings on PEEK surface: stability over time and anti-inflammatory effects in vitro

Autori: Erika Roventini, Francesco Iacoponi, Aliria Poliziani, Paolo Canepa, Ornella Cavalleri, Maria A. Cassa, Paola Parlanti, Carlotta Pucci, Mauro Gemmi, Chiara Tonda-Turo, Leonardo Ricotti
Pubblicato in: Scientific Reports, Numero 15, 2025, ISSN 2045-2322
Editore: Nature Publishing Group
DOI: 10.1038/s41598-025-25082-5

Laboratory Protocol and Pilot Results for Dynamic Interference Testing of Continuous Glucose Monitoring Sensors

Autori: Andreas Pfützner; Hendrick Jensch; Christopher Cardinal; Geetham Srikanthamoorthy; Eric Riehn; Nicole Thomé
Pubblicato in: Journal of Diabetes Science and Technology, 2022, Pagina/e 1-7, ISSN 1932-2968
Editore: Diabetes Technology Society
DOI: 10.1177/19322968221095573

Deep prediction networks

Autori: Alberto Dalla Libera; Gianluigi Pillonetto
Pubblicato in: Neurocomputing, 2022, Pagina/e 321-329, ISSN 0925-2312
Editore: Elsevier BV
DOI: 10.1016/j.neucom.2021.10.054

"Response to Comment on ""Minimal and Maximal Models to Quantitate Glucose Metabolism: Tools to Measure, to Simulate and to Run in Silico Clinical Trials"""

Autori: Claudio Cobelli; Chiara Dalla Man
Pubblicato in: Journal of Diabetes Science and Technology, 2021, Pagina/e 1-2, ISSN 1932-2968
Editore: Diabetes Technology Society
DOI: 10.1177/19322968211060069

Optimized Magnetically Docked Ingestible Capsules for Non‐Invasive Refilling of Implantable Devices

Autori: Hind Al‐Haddad, Daniele Guarnera, Izadyar Tamadon, Lorenzo Arrico, Giulia Ballardini, Francesco Mariottini, Alessio Cucini, Simone Ricciardi, Fabio Vistoli, Maria Isabella Rotondo, Daniela Campani, Xuyang Ren, Gastone Ciuti, Benjamin Terry, Veronica Iacovacci, Leonardo Ricotti
Pubblicato in: Advanced Intelligent Systems, Numero 6, 2025, ISSN 2640-4567
Editore: Wiley
DOI: 10.1002/aisy.202400125

650-P: Attitudes and Barriers to Implantable AID Solutions—Development of a New Assessment Tool

Autori: NORBERT HERMANNS, KATHARINA FINKE-GROENE, BERNHARD KULZER, DOMINIC EHRMANN
Pubblicato in: Diabetes, Numero 73, 2024, ISSN 0012-1797
Editore: American Diabetes Association
DOI: 10.2337/db24-650-p

Artificial Pancreas: In Silico Study Shows No Need of Meal Announcement and Improved Time in Range of Glucose With Intraperitoneal vs. Subcutaneous Insulin Delivery

Autori: Chiara Toffanin; Lalo Magni; Claudio Cobelli
Pubblicato in: IEEE Transactions on Medical Robotics and Bionics, 2021, Pagina/e 306-314, ISSN 2576-3202
Editore: IEEE
DOI: 10.1109/tmrb.2021.3075775

968-P: Factors Associated with the Decision to Use an Implantable AID System

Autori: DOMINIC EHRMANN, KATHARINA FINKE-GROENE, BERNHARD KULZER, NORBERT HERMANNS
Pubblicato in: Diabetes, Numero 73, 2024, ISSN 0012-1797
Editore: American Diabetes Association
DOI: 10.2337/db24-968-p

606-P: What Do People with Type 1 Diabetes Think of a Fully Implantable Bionic Invisible Pancreas? A Qualitative Study

Autori: DOMINIC EHRMANN, KATHARINA FINKE-GROENE, BERNHARD KULZER, NORBERT HERMANNS
Pubblicato in: Diabetes, Numero 71, 2022, ISSN 0012-1797
Editore: American Diabetes Association
DOI: 10.2337/db22-606-p

Early Impairment of Insulin Sensitivity, β-Cell Responsiveness, and Insulin Clearance in Youth with Stage 1 Type 1 Diabetes

Autori: Galderisi, Alfonso; Moran, Antoinette; Evans-Molina, Carmella; Martino, Mariangela; Santoro, Nicola; Caprio, Sonia; Cobelli, Claudio
Pubblicato in: The Journal of Clinical Endocrinology & Metabolism, 2021, ISSN 0021-972X
Editore: The Endocrine Society
DOI: 10.1210/clinem/dgab344

Conference proceedings (3)

Personalized LSTM-Based Alarm Systems for Hypoglycemia Prevention in an Intraperitoneal Artificial Pancreas

Autori: Martina Drecogna, Claudio Cobelli, Chiara Toffanin
Pubblicato in: 2024 32nd Mediterranean Conference on Control and Automation (MED), 2024, Pagina/e 233-238
Editore: IEEE
DOI: 10.1109/med61351.2024.10566183

The Official Journal of ATTD Advanced Technologies &amp; Treatments for Diabetes Conference 22‐25 February 2023 I Berlin &amp; Online

Autori: Drecogna M., Toffanin C., Galderisi A., & Cobelli C
Pubblicato in: Diabetes Technology &amp; Therapeutics, Numero 25, 2023, Pagina/e A-1-A-269, ISSN 1520-9156
Editore: Mary Ann Liebert Inc.
DOI: 10.1089/dia.2023.2525.abstracts

The Official Journal of ATTD Advanced Techologies &amp; Treatments for Diabetes CONFERENCE 6–9 MARCH 2024 I FLORENCE &amp; ONLINE

Autori: Drecogna M., Toffanin C., Galderisi A., & Cobelli C
Pubblicato in: Diabetes Technology &amp; Therapeutics, Numero 26, 2024, Pagina/e A-1-A-376, ISSN 1520-9156
Editore: Mary Ann Liebert Inc.
DOI: 10.1089/dia.2024.2525.abstracts