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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.
Project Initiation
Project management handbook
Project website
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.
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.
Ethical committee approval 1
MS1- ip glucose sensing feeding the ip algorithm
MS2 - Regulatory approval of implementation surgical procedure and preclinical BIP validation in vivo trials
MS3 - Components of the ip delivery system (telemetry and coatings excluded
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.
Prelim. report on sensor, control algo and pump bench testing
Ethical committee approval
Safety of implantation and ip sensor functionality in pigs
The new system will be tested in pigs after obtaining Ethic committee approval
Final report on sensor, control algo and pump bench testing
MS4 - Results of bench tests and adaptations in view of in vivo tests
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.
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.
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.
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
In vivo validation of BIP components and full system
Final project report
Final project presentation by website, public conferences, meetings and scientific reports
MS6 - First-in-human trial results
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