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Empowered control of drugs’ dosage in chronic diseases

Periodic Reporting for period 2 - INSULCLOCK (Empowered control of drugs’ dosage in chronic diseases)

Reporting period: 2017-07-01 to 2018-07-31

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 the 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 diabetics’ 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 innovative business project are:
1. To help diabetics worldwide to better adhere to their treatment via insulin pens, preventing hospitalization and serious complications and adjusting to nowadays living styles.
2. Assist their caregivers, especially for children and elder, for whom miss-treatment could have worse consequences and find it harder to stick to the routine of insulin shots.
3. Help 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. Collaborate with the pharmaceutical sector by early alerting diabetics when they need to buy more insulin, and improving the service offered by current pens.
6. Partner with 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 to treatment, insurance companies can offer advantageous prices and service offer.

It can be therefore concluded that we have completely achieved the objectives set out in the project and the overall goals of our innovative business project are more than ever closer to be achieved, improving diabetics’ quality of life, which has been our leitmotiv from the very beginning.
Regarding INSULCLOCK device, 200 industrial prototypes for trials and demonstrators have been manufactured. Several testing and refinement cycles have been performed until excellent reliability was obtained.
As an indispensable tool complementary to INSULCLOCK device, we have developed a Telemedicine Platform aimed to create further evidence of the impact that INSULCLOCK® 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.

During this period, in order to obtain scientific support, Insulclock® and the associated telemedicine system have been tested in a real environment. Two clinical trials have been run in collaboration with prestigious hospitals and the results have been analysed and statistically treated to provide further evidence on the impact that Insulclock® and the telemedicine system has over the adherence to treatment and over the relationship between therapists and diabetics, respectively. The results have been analysed and statistically treated and further published in open access high impact journals.

Additionally, the first steps towards further collaborations to enhance scientific support have been achieved thanks to the identification of two new areas where Insulclock® technology can be applied: disorders treated with grow hormone and autoimmune disorders.

The whole project has been very intensive in terms of dissemination activities in order to establish strong networks at national and international level with diabetes associations, pharmaceutical, health insurance, and e-health companies, as well as healthcare professionals in order to promote INSULCLOCK®, to look for business opportunities and to sign stable commercial agreements. We have focused our efforts on disseminating INSULCLOCK benefits through diabetes sector stakeholders and on establishing collaboration agreements with them. 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 and IPR protection issues, extending our PCT patent to the target regions. We have also participated in the most relevant national and international diabetes congresses, events and fairs celebrated disseminating the results of the project.
Insulclock is already on the market.
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 connects the insulin pen with our mobile or sends data to the Cloud to have a statistical control of medication. The similar solutions in the market, just store and analyze information, but data input is manual, so insulin and health control are still subject to patient’s oversights and errors.

The following results are expected until 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 Insulclock® preventing complications, improving adherence of treatment and increasing quality of life.
- 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.
- Overcome the certification barrier, such as FDA certificate for US market.
- Accelerate the international expansion by disseminating our results among the main stakeholders in diabetes.

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 diabetics’ adherence to treatment, which would result in a better quality of life for them, reducing complications, and in an immense economic saving in Europe.