Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - Insulog (The Smart snap-on insulin tracker able to manage the insulin intake activity data of diabetes patients)

Teaser

\"What is the problem/issue being addressed?Many people on insulin report problems of not remembering whether or not they took an injection - missing insulin injections can lead to a dangerous quandary. Moreover patients usually need to manually register the intake time and...

Summary

\"What is the problem/issue being addressed?
Many people on insulin report problems of not remembering whether or not they took an injection - missing insulin injections can lead to a dangerous quandary. Moreover patients usually need to manually register the intake time and dosage of the last injection: this method wastes time and energy. Finally complications of a missing insulin injection represent a huge burden for the healthcare systems: Insulog device allows to contain the costs related to hospitalization thanks to precise and constant monitoring of insulin intake activity.

Why is it important for society?
Insulog removes the element of human error in diabetes day-to-day management. It always shows the last insulin intake, preventing life-threating medical emergencies. This way, Insulog also reduces medical costs related to diabetics’ hospitalizations, and allows patients to better manage diabetes.

What are the overall objectives?
Objective#1: Finalize device development, including:
• Improve App’s & device design for better user experience, make the device compatible with new insulin pens (e.g. creation of a bigger screen for elderly and people with visual impairment; insertion of voice command for elderly and people with visual impairment; Dosage history also on the device screen, in addition to the last injection);
• Software localization for the main EU markets (translation in German, French, Italian, Spanish, Hebrew)

Objective#2: Manufacture and test first batch of 300 devices to be supplied for the following clinical study

Objective#3: Conduct a clinical study in EU5 for continued clinical testing and evaluation of functional/safety data. Demonstrate improved A1C outcomes. The study will be carried out in 3-5 clinical sites and will be implemented considering a sample size of about 150-300 patients, identifiable among the following subjects:
• Men or women
• Age between 21 and 70 years old
• With a History of Diabetes Mellitus type 1 or 2 for more than 5 years
The clinical pilot study is intended to evaluate the performance of Insulog device in overall reduction average levels of blood glucose (A1C) and glycemic control maintenance.

Objective#4: Achieve CE marking; develop and implement sound European IP strategy, plan and validate strong commercial scale-up strategy, carry out dissemination and communication activities.


\"

Work performed

Definition of MVP and future developments, product development plan and industrialisation plan, including risk assessment and supply chain development. Review and update of the business plan, go-to-market study and outline of the clinical study.

Final results

Insulog is a handy little smart device that snaps onto all insulin pens. It detects and shows the last intake time and dose andautomatically synchronizing it to an app, where you can review & store data, easily sharing it with the medical team. Since over 95% of patients use disposable insulin pens, this provides a competitive advantage with comparison to companies providing reusable pens. In addition to this, Insulog is the first device to automatically record the insulin dose in real time. This lets patients to keep track of their insulin injections at any time, everywhere.
The total cost of European healthcare was approximately €1.48 trillion in 2014, of which approximately 12% is attributed to diabetes18. In particular, complications of a missing insulin injection represent a huge burden for the healthcare systems. For example, every year in the USA, about 282,000 emergency room visits for adults had hypoglycemia19 (low sugar level in bloodstream) as the first-listed diagnosis and diabetes as secondary diagnosis20. Most of these visits lead to hospitalization. Indeed, for diabetic patients the rate of hospital admissions from the emergency room is over four times greater than the average. Hospitalization represents the biggest share of the direct costs associated with diabetes care. It implies admission to hospital, laboratory analysis, the work of the medical staff and specific therapies. The average emergency visit cost of a diabetic patient eventually results three times higher than any other visit21. With the help of Insulog, insulin uncertainties can be reduced. This reduces emergency room visits and hospitalizations related to diabetes‟ complications and significant decrease in medical costs (around 60% of global diabetes costs22). An equivalent cost saving of at least €106.56 billion every year. In addition, Insulog has discussed the potential impact of the device with various stakeholders including patients and representatives from healthcare industries. These discussions assisted the company in identifying the main factors influencing their willingness to pay for the Insulog system

Website & more info

More info: http://www.insulog.life/.