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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - INSULCLOCK (Empowered control of drugsâ€™ dosage in chronic diseases)

Teaser

Summary

Diabetes is a serious and painful disease, and its rapidly increasing prevalence is a significant cause for concern. In 1985, an estimated 30 million people worldwide suffered from diabetes; in year 2000 the figure had risen to over 150 million. By 2025, the figure is expected to rise to 380 million. In many cases (all type I patients and part of type II ones), treatment is based on creating exogenous insulin in-taking routines aiming at keeping blood glucose levels within the normal range; the great challenge comes from the adherence to the treatment. In case treatment fails or the compliance is not optimal, there is a high risk of complications related to vascular and nerve affection.

In spite of the risks, keeping 24h proper track of their disease is not an easy task for diabetics. Between other, it is really hard to keep consciousness of a routine task to be performed every 2-3 hours along lifetime, and, as in any other chronic illnesses, very often the patient may forget to take insulin. This also becomes of great importance for people in charge of diabetics when very young or very old to keep full control of their disease, and for which miss-treatment can be more dangerous.

According to the Health and Food Safety department of the EC , diabetes causes very high direct costs in national health systems, ranging between 6.4 % (Sweden) and 13.2 % (Portugal) of all health expenditure, due to the hospitalization costs related to complications. Indirect costs caused by loss of productivity (disability, sick leave, retirement and premature death) are around five times bigger than direct costs. Improving diabeticsâ€™ adherence to treatment would result in a better quality of life for them, reducing complications, and in an immense economic saving in Europe.

The overall goals of our innovation business project are to help:
1. Diabetics worldwide to better adhere to their treatment via insulin pens, preventing hospitalization and serious complications and, at the same time, adjusting to nowadays living styles.
2. Their caregivers, especially for children and elder, for whom miss-treatment could have worse consequences and, at the same time, find it harder to stick to the routine of insulin shots.
3. Medicine practice, since specialists could have access to extensive and accurate data to be able to give better advice and adjustment of therapies.
4. Reducing health costs. There have been a number of analyses of the effect of adherence on costs, which prove an inverse correlation between them (up to $1500 saving per patient with proper adherence) .
5. The pharmaceutical sector by early alerting diabetics when they need to buy more insulin, and improving the service offered by current pens.
6. Insurance companies, who up to now have found great difficulties in giving health coverage to diabetics due to uncertain heavy costs. With a system capable of guaranteeing the adherence of the person to treatment, insurance companies can offer advantageous prices and service offer.

Work performed

Regarding INSULCLOCK device, preparation of the industrial prototypes for trials and demonstrators as well as product manufacturing planning have been achieved. Several testing and refinement cycles have been performed until excellent reliability was obtained. As a result of all these activities, 100 non-commercial units of INSULCLOCKÂ® for the clinical trials and demonstrators have been manufactured.

During this period, in order to obtain scientific support for our product, we have run the first steps needed to launch fully the demonstration phase by September 2017. In this regard, the protocol for the trials has been finished and approved by a prestigious University Ethical Committee in USA, as well as a complete plan for the management of ethical issues.

As an indispensable tool complementary to INSULCLOCK device, we have developed a Telemedicine Platform aimed to create further evidence of the impact that INSULCLOCKÂ® has over the relationship between therapists and diabetics, and in the adherence of patients to treatment. After defining and implementing the technology required, a first full version of the Telemedicine platform has been built. Another important achievement during this period has been its synchronization with our INSULCLOCKÂ® prototypes.

An intensive first year of dissemination activities has been performed focused on establishing strong networks at national and international level with diabetes associations, pharmaceutical companies, e-health companies, health insurance companies and healthcare professionals in order to promote INSULCLOCKÂ®, to look for business opportunities and in the long term to sign stable commercial agreements. We have focused our efforts on disseminating INSULCLOCK benefits through diabetes sector stakeholders and on establishing collaboration agreements with the stakeholder previously mentioned. We have also extended our contact network in the USA and opened it to Middle East. Additional activities related to exploitation have been carried out, such as a constant survey of new products emerging in the market that can become competitors in the near future and IPR protection issues.We have also participate in the most relevant national and international diabetes congresses, events and fairs celebrated.

Final results

INSULCLOCK covers the need to provide security and increase the quality of life to the patients giving a wearable solution completely integrated into their treatment routine. It is the first wearable for the insulin pen that allows an optimal follow up of the treatment and brings significant progress against its competitors, since none of them connect the insulin pen with our mobile or send data to the Cloud to have a statistical control of medication. The similar solutions in the market, most of them app,s let people record, store and analyze information, but data input is manual, so insulin and health control is still subject to patientâ€™s oversights and errors.

The following results are expected unti the end of the project:
- Fully adapt our current near-to-industrialized prototype for industrial production
- Perform clinical trials to create evidence of the effectiveness of InsulclockÂ® preventing complications, improving adherence of treatment, increasing quality of life, carried out with real diabetics.
- Develop and test a telemedicine system with the collaboration of a prestigious hospital.
- Protect our innovative product applying for the National Phases of the PCT to target regions not covered by the European Patent: Mexico, USA, Canada, Russia, Israel, Japan, India, China and Brazil.
- Overcome the certification barrier, supported by our international partners, well established in the target countries and experienced in achieving certifications there, such as FDA certificate for US market
- Accelerate the international expansion by disseminating our results among the doctors, diabetes educators, hospitals, diabetes associations, health insurance companies and healthcare providers.

According to the Health and Food Safety department of the EC , diabetes causes very high direct costs in national health systems. With INSULCLOCK we aim to improve diabeticsâ€™ adherence to treatment, which would result in a better quality of life for them, reducing complications, and in an immense economic saving in Europe.