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Project Progress

Timeline

Here you can follow the project development, exploring major achieves and project milestones as well. In the timeline will highlight publications and relevant public disseminations too. FORGETDIABETES follows the EC guidelines on Open Access, therefore, all public material produced is reachable and available hereunder.

1st of Oct 2020
Project Initiation
1st of Oct 2020
31 December 2020
Project management handbook

Project website
31 December 2020
31 July 2021
Focus Group & human factors identification
Semi-structured interviews in different user population subgroups Patients 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.
31 July 2021
30 September 2021
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.
30 September 2021
31 November 2021
Ethical committee approval 1
31 November 2021
30 January 2022
MS1- ip glucose sensing feeding the ip algorithm
30 January 2022
30 March 2022
MS2 - Regulatory approval of implementation surgical procedure and preclinical BIP validation in vivo trials
30 March 2022
30 September 2022
MS3 - Components of the ip delivery system (telemetry and coatings excluded
30 September 2022
1 October 2022
Preliminary report on ip personalized, control algorithm
The algorithm will be developed according to the preliminary data gathered and to the performance of the sensor.
1 October 2022
1 October 2022
Prelim. report on sensor, control algo and pump bench testing

Ethical committee approval
1 October 2022
30 September 2023
Safety of implantation and ip sensor functionality in pigs
The new system will be tested in pigs after obtaining Ethic committee approval
30 September 2023
30 September 2023
Final report on sensor, control algo and pump bench testing

MS4 - Results of bench tests and adaptations in view of in vivo tests
30 September 2023
30 September 2024
New questionnaire to assess patient satisfaction
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.
30 September 2024
30 September 2024
Online education and training tool
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.
30 September 2024
30 September 2024
Eligibility criteria & patient emergency card for risk mitigation
The abovementioned 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.
30 September 2024
30 September 2024
Final reports on each single-exposure experiments

Updated Data Management Plan

Ip algo (sc sensor & ip delivery) safety and efficacy in patients

MS5 - in vivo validation of BIP components
30 September 2024
31 May 2025
In vivo validation of BIP components and full system
31 May 2025
31 May 2025
Final project report
Final project presentation by website, public conferences, meetings and scientific reports
31 May 2025
31 May 2025
MS6 - First-in-human trial results
31 May 2025

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Information on personal-data processing by the FORGETDIABETES website

Information pursuant to Articles 13 and 14 of EU Regulation 2016/679
Pursuant to Articles 13 and 14 of EU Regulation 2016/679 on data protection (GDPR), we inform you that the personal data you provided voluntarily to the University of Padova will be processed by adopting suitable measures to ensure their safety and confidentiality in full compliance with the GDPR.

 1. Purposes and methods of data processing 

1.1. Navigation data. 
The information systems that run the FORGETDIABETES website (forgetdiabetes.eu) automatically acquire on a daily basis some of the personal data transmitted when web communication protocols are used. If these personal data are processed with data held by third parties, they could identify users and/or visitors. These personal data include the IP address and computer domain names used to connect to forgetdiabetes.eu. These data are normally collected for anonymous statistical surveys and are used to make it easier to navigate forgetdiabetes.eu.

1.2. Cookies.
The FORGETDIABETES website uses cookies, i.e. small text files that are sent from the website’s server to your browser and are automatically saved on your computer. They are used for statistical surveys for the sole purposes of improving the University’s services and we therefore recommend you configure your browser to accept them. The vast majority of browsers are configured to accept cookies; you can, however, change your browser settings to block them. See point 1.2.2 “How to disable cookies (opting-out)”.

1.2.1. Cookies
Cookies can be disabled without having any effect on your website experience. The University uses Google Analytics, a service provided by Google Inc., (hereinafter called “Google”) to generate statistics on how its website is used. Google Analytics uses cookies, but they do not store your personal data and are not third-party. Cookies contain information on your website use, including your IP address, and will be sent by your browser to Google, which is based at 1600 Amphitheatre Parkway, Mountain View, CA 94043, United States, where they will be stored on the company’s servers. In accordance with the current terms of service, Google will use this information in its role as an independent data processor to track and examine website use, draw up reports on website-activity, and provide services related to your website-activity, device (e.g. mobile phone, pc, browser) and how you search for and arrive at the information you require. Google may also send this information to third parties to meet legal requirements or when said third parties process your information on behalf of Google. Google will not associate your IP address with any other data in its possession.
To consult Google’s privacy information for its Google Analytics service, please visit https://support.google.com/analytics/answer/6004245?hl=en.
To read more about Google’s privacy policy, please visit http://www.google.com/intl/it/policies/privacy/.
When you use the University’s website, you consent to having your personal data processed by Google in the above ways and for the above purposes. 

1.2.2. How to disable cookies (opting-out)
If you do not want to consent to the use of cookies, you can disable them by changing your browser settings. Browsing the website as an unauthenticated user does not hinder any of the website’s functions. Below are links that explain how to disable cookies on the main browsers. If you use another browser, we suggest you look for the “disable cookies” in the “help” option. This option is normally available by pressing F1.
Internet Explorer: http://windows.microsoft.com/it-IT/windows7/Block-enable-or-allow-cookies
Google Chrome: https://support.google.com/chrome/answer/95647?hl=it-IT&p=cpn_cookies
Mozilla Firefox: https://support.mozilla.org/it/products/firefox/protect-your-privacy/cookies
Apple Safari: http://www.apple.com/legal/privacy/it/cookies/
Alternatively, you can choose to disable Google Analytics cookies only by installing Google’s opt-out add-on, which it provides for the main browsers.

1.2.3. Remarketing e Behavioral Targeting

Facebook Custom Audience (Facebook, Inc.) 
Facebook Custom Audience is a remarketing and behavioral targeting service provided by Facebook, Inc. that connects the activity of this Website with the Facebook advertising network.
Personal Data collected: Cookies; email address.
Place of processing: United States – Privacy Policy – Opt Out. Privacy Shield participant.

Facebook Remarketing (Facebook, Inc.)

Facebook Remarketing is a remarketing and behavioral targeting service provided by
Facebook, Inc. that connects the activity of this Website with the Facebook advertising network.
Personal Data collected: Cookies; Usage Data.
Place of processing: United States – Privacy Policy – Opt Out. Privacy Shield participant.

1.3 Purposes and storage of data 
Collected data are processed for statistical analysis for the sole purposes of improving services; therefore, they will be stored for the minimum time needed to perform a service.

1.4. Data processing
Your data will be processed manually, as well as by electronic and automated means, for the following purposes in accordance with the limits and conditions of the General Data Protection Regulation (GDPR) 2016/679: collection, recording, organisation, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.

2. Disclosure and dissemination of data
Your personal data will not be disseminated or disclosed to third parties unless provided for by the University’s dataprocessing information and/or by the law. In these cases, data will be disclosed and/or disseminated in accordance with the methods allowed.
Your data may be disclosed to processors or to persons tasked with processing as part of their job and in accordance with the instructions they receive, but solely for the purposes stated in this information.

3. Rights of the data subject
Regarding your personal data, you may exercise the rights provided for by the General Data Protection Regulation 2016/679 by sending an email to: [email protected]

4. Data Controller 
The Data Controller is the University of Padova, which is based at Via VIII Febbraio no. 2, Padova, Italy. A complete list of data processors can be consulted at this address.

5. Contact details of the Data-protection officer
You can contact the University’s Data-protection officer at: [email protected].

Updated on: 31 May 2019