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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - SMASH (The first non-invasive device for continuous, real-time monitoring of glucose and lactate through sweat analysis)

Teaser

Summary

Interest in smart wearable devices has grown exponentially over the last few years. This is due to steadily increasing requirements for self-health monitoring and preventive medicine, pushed by the projected dramatic increase in the number of elderly people, those affected by diabetes, obese individual, and increased stress levels.
Overall, in healthcare, sport, and exercise science, a strong need on continuous data of key biomarkers for assessing human health and wellbeing is expressed. This owes to the fact that continuous monitoring of key parameters (e.g. hydration status, glucose, lactate, etc.) would provide the chance to intervene in case of critical peaks (e.g. glucose level in for diabetes patients or injuries for athletes), and to assess the evolution of pathologies and treatments or progresses of personalized training.
Currently, such biomarkers are being measured in patients and athletes through invasive and painful procedures (typically blood essays/finger-prick tests or flash monitors placed underneath the skin), several times a day and with no technology able to provide simultaneous measurements in continuous way. This is particularly true for two key biomarkers, glucose and lactate.
On one hand, blood glucose levels are key for the early detection and management of diabetes. Currently more than 56 million people are affected in Europe alone (International Diabetes Federation data) and thus need to measure glucose levels several times a day through invasive tools.
On the other hand, lactate threshold is one of the most commonly and effectively used markers for defining the upper limit of the sustainable efforts in training and competition, thus representing a key factor for injury prevention in athletes. As per the glucose levels, lactate is measured by analysing blood samples taken through finger-prick tests during and after training sessions. High lactate production is even an often-neglected factor in diabetic patients. Lactic acidosis is an acute condition that can occur early on, if there is an imbalance between energy expenditure and oxidative capacity. Cardiovascular complications, which can cause hypoxia, can also lead to an increase in lactate levels. Finally, in Gestational Diabetes Mellitus (GDM) a high concentration of lactate in blood can be partially responsible for the development of insulin resistance.
Innovosens is specialized in developing micro-sensing devices for sensing metabolites in sweat. SMASH is the first product towards the development of new devices for Diabetes management and Fitness support. It is a wearable device to be fixed onto the skin like a patch or a wrist band, whose core technology is a microanalytical flow system. The flow system includes a soft sweat sampling microfluidic system, able to collect small sweat samples (5 Mmol) and continuously replace them with fresh sweat. The samples collected are sent to electrochemical detectors functionalized with proper molecules to monitor in real-time sweat metabolites such as glucose, lactate and ketones.
The overall objectives of the Project includes completing the engineering of the system and work toward the required certifications to compete in the European market.

Work performed

From a technical point of view, during the Feasibility study the consept of SMASH was redisigned to be more user friendly and facilitate the industrialization. The system was tested both in lab and on people. In particular tests were conducted in collaboration with the University of Ã–rebro, with 10 volunteers which were tested in different conditions (during fitness, before and after eating, etc.). All tests were successful and we improved the correlation curves used to analyze the molecule concentration in sweat.
From a practical and business point of view, the team started by studying the path toward CE marking and the requirements for apply to National Reimbursement from National Health Systems in target markets in Europe. To do this the company started introduction with different CROs and consultants which will become partners during the next step of the Project. Moreover the team exploit the Phase 1 to contact different stakeholders interested in SMASH (more than 30) to validate the technology and gather requirements from people already in the market.
Feedbacks were very positive, especially for the Health application of SMASH.
We continued improving our knowledge of the market and the value chain, then refining our business strategy, including pricing strategy and marketing strategy.

Final results

As highlighted by our interactions, SMASH is poised to be the first not-invasive Continuous Glucose Monitor (CGM) system on the market. This will help the diffusion of CGM systems among the diabetes community, in particular on Type II patients, drastically reducing complications and sudden accidents due to the use of single-point measurements, such as the test strips. Moreover the use of SMASH will lower the risk of infection diffusion, thanks to the reduction of pricks needed.
SMASH is a multi-parameter and it is the first CGM system able to monitor the presence of dangerous condition such as Lactoacidosis and Ketoacidosis, which are all connected with diabetes pathology, and can hardly been checked monitoring only glucose.
SMASH price is poised to be well below existing solution, reducing costs for patients and National Systems, allowing the use of this technology on a larger public base.
Innovosens aims to continue the development of this Project, exploiting both public and private financing to complete the engineering of the system and move SMASH from prototype to industrialization.