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ECSEL JU / IMI2 JU Joint workshop
Caretek and the Sprintt project
Brussels, 5 July 2017
Gianluca Zia (Caretek srl)
ECSEL JU / IMI2 JU Joint workshop
Caretek, Adamo and Sprintt
2010: Caretek has been founded as a spinoff of Consoft Sistemi, a
leading Italian Information and telecommunication company
Objective: Create a center for research and development in solutions for telecare and telemonitoring, cooperate with all the skills needed to develop technologically advanced solutions
Main goal: technological evolution of ADAMO, a teleservice and telemonitoring solution for frail subjects, resulting from the development of a research project of “Istituto Superiore Mario Boella”
2014: Caretek has started participating in Regional and European research projects to evolve the ADAMO platform; These projects originate both from integration with telemedicine solutions, and the implementation of components for the management of service centers.
SPRINTT: Thanks to the participation in the SPRINTT project, aimed to find effective solutions for the treatment of physical frailty and sarcopenia, Caretek became a technological and methodological integrator in the management of clinical trial.
2017: Evolution of Adamo device and integrated platform for clinical trials: SARA OBS Project by Biophytis
ECSEL JU / IMI2 JU Joint workshop
Lack of adapted
Screening
& Diagnostic tools
Lack of personalized
Integrated solutions
Lack
of Scientific
Consensus &
Regulatory
Pathways
Lack of
Therapetic
guidelines
Lack of
Health Litteracy
Lack
of Medico Economic
Model
to capture the
value created
| 1
Sarcopenia Physical fRailty IN older people: multi-componenT Treatment strategies
ECSEL JU / IMI2 JU Joint workshop
- 1500 patients - Patient Follow up : 24 months - 14 sites - 11 European Countries - 7 regional areas - 9 backup sites
Pre-selected study site
New study sites
SPRINTT project – numbers
ECSEL JU / IMI2 JU Joint workshop 5
Sprintt Workpackages&Deliverables
ECSEL JU / IMI2 JU Joint workshop
Integration – The ESB
ECSEL JU / IMI2 JU Joint workshop
SPRINTT ICT Architecture
IoT
ECSEL JU / IMI2 JU Joint workshop
eCRF
ECSEL JU / IMI2 JU Joint workshop
SPRINTT application
ECSEL JU / IMI2 JU Joint workshop
Adamo
Wrist watch Base station SIM card
ECSEL JU / IMI2 JU Joint workshop
Security at home
Customization for retirement home
Safety at workplace
Adamo applications
Continuous health monitoring
ECSEL JU / IMI2 JU Joint workshop
… and outdoor
activity
Android device
for user
interaction
Customized version of Android dedicated to elderlies
ADAMO : Actimetry/falls and near falls detection device
Adamo for Sprintt
ECSEL JU / IMI2 JU Joint workshop
ADAMO - Step Detection algorithm A single step, defined as a unit cycle of walking behavior, maybe described as the
sequence stage of the walking cycle and the change in vertical and forward
acceleration, thus leading to a typical pattern of x-, y-, and z- measurements.
In this kind of analysis, the relevant parameter is thus acceleration. The three
components of motion for an individual are forward, vertical, and side. The
accelerometer senses acceleration along its three axes: x, y, and z. The real problem is
that the sensor will be in an unknown orientation, being integrated in a wristwatch. At
least one axis will have relatively large periodic acceleration changes, no matter how the
accelerometer is worn.
ECSEL JU / IMI2 JU Joint workshop
Fall detection algorithm
Acceleration pattern recognition is
performed by means of a finite state
machine aimed to detect the sequence of
three different states: freefall, impact,
immobility
If the sequence is detected, a fall alarm is
internally raised as a firmware interrupt
event.
ECSEL JU / IMI2 JU Joint workshop
Adamo Report
ECSEL JU / IMI2 JU Joint workshop
ECSEL JU / IMI2 JU Joint workshop
6 Months 300 Participants 8 Centers 4 Countries (US-EU)
USA
Europe
Characterizing the target population for SARA-Int, an interventional CT Objective measurements of mobility function body composition (via DXA) Patient Reported Outcomes Patient centered design Administering PROs via remotely connected devices (tablet, PCs, etc.) Personal wearable device to collect physical activity data Semi-permanent clinical trial infrastructure Centered on geographic areas and their clinical investigation centers Data will be available for secondary research in sarcopenia New integration: ePROs, Lab Exam, New Adamo Reports, Dedicated website as entry portal
• Tuft University – Boston
• University of Florida – Gainesville
• Université de Liége
• Gerontopôle - Toulouse
• CHU –Lyon Sud
• CHU - Limoges
• Sapienza University - Rome
• Campus Biomedicus - Rome
ECSEL JU / IMI2 JU Joint workshop
Conclusions and next steps
SPRINTT: the first IMI project in Geriatrics – a wide European cooperative
undertaking between Pharma Industry and Academia that integrates novel ICT solutions into a large randomized clinical trial with clear-cut Regulatory Objectives for a novel geriatric indication.
SARA–data, a drug development program by Biophytis: Caretek and Bluecompanion developed and implemented a second generation clinical trial platform incorporating ePROs and continuous physical activity data recording
Next steps: an Academia-driven collaborative project designed by Bluecompanion to capture long-term good quality clinical data in older patients with limited mobility confined at home
Next steps: based on ongoing initiatives, continuing to discuss the most adapted methodologies requirements with regulatory agencies both in the EU and US for a “big data” approach on clinical data.
ECSEL JU / IMI2 JU Joint workshop
Agenda
19
Thanks for your attention !