caretek and the sprintt project - ecsel ju€¦ · ecsel ju / imi2 ju joint workshop caretek, adamo...

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ECSEL JU / IMI2 JU Joint workshop Caretek and the Sprintt project Brussels, 5 July 2017 Gianluca Zia (Caretek srl)

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Page 1: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

ECSEL JU / IMI2 JU Joint workshop

Caretek and the Sprintt project

Brussels, 5 July 2017

Gianluca Zia (Caretek srl)

Page 2: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

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

Page 3: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

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

Page 4: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

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

Page 5: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

ECSEL JU / IMI2 JU Joint workshop 5

Sprintt Workpackages&Deliverables

Page 6: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

ECSEL JU / IMI2 JU Joint workshop

Integration – The ESB

Page 7: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

ECSEL JU / IMI2 JU Joint workshop

SPRINTT ICT Architecture

IoT

Page 8: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

ECSEL JU / IMI2 JU Joint workshop

eCRF

Page 9: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

ECSEL JU / IMI2 JU Joint workshop

SPRINTT application

Page 10: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

ECSEL JU / IMI2 JU Joint workshop

Adamo

Wrist watch Base station SIM card

Page 11: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

ECSEL JU / IMI2 JU Joint workshop

Security at home

Customization for retirement home

Safety at workplace

Adamo applications

Continuous health monitoring

Page 12: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

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

Page 13: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

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.

Page 14: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

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.

Page 15: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

ECSEL JU / IMI2 JU Joint workshop

Adamo Report

Page 16: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

ECSEL JU / IMI2 JU Joint workshop

Page 17: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

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

Page 18: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

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.

Page 19: Caretek and the Sprintt project - Ecsel Ju€¦ · ECSEL JU / IMI2 JU Joint workshop Caretek, Adamo and Sprintt 2010: Caretek has been founded as a spinoff of Consoft Sistemi, a leading

ECSEL JU / IMI2 JU Joint workshop

Agenda

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Thanks for your attention !