An interview with MuSiC4Diabetes coordinator Martin Richter

One year has passed since the MuSiC4Diabetes project was launched. To this occasion, Martin Richter, coordinator of the project, answered some questions on the origins of the project, its mission, as well as the concrete vision for the device in development.

How was the MuSiC4Diabetes project born?
A project partner from the USA has been dreaming of an implantable insulin dosing system with us for a long time. Through this partner I met Eric, who has been providing patients in Montpellier with implantable dosing systems for over 20 years, and also Claudio, who is a very well-known expert in blood sugar control algorithms at Uni Padova. Through him, we became acquainted with the company Indigomed in Belgium, which has great multi-parameter sensor technology, and also a leading research institute for human factors (FIDAM). We had thus formed an excellent European consortium to realize this dream as part of a Pathfinder project.

What is the meaning behind the project name “MuSiC4Diabetes”?
Diabetes patients have an enormous burden to bear, day after day. If we can make our dream come true, then a large part of this burden will be lifted from the patients. Patients will no longer have to think about their illness every day; a space will open up for them for dreams, music, relaxation. I think it was this association that, when we discussed the project name, tipped the balance in our decision to follow Claudio's suggestion.

What are the innovations of the micropump used in the MuSiC4Diabetes device?
First of all, we have an innovative multi-parameter sensor from our partner Indigomed, with which we can measure not only blood sugar, but also other parameters such as ketones and lactates. This allows us to take sporting activities into account much better, for example. Our specialists in the field of algorithms ensure that these parameters are converted into an optimal control of our implantable insulin pump. This micropump is tiny (7x7x2 mm3), but meets the tough requirements for long-term operation in the body. The safety requirements are also high: a safety valve prevents free-flow, and a new monitoring function reliably detects faults in the microdosing module. Due to the small stroke volume of the micropump, which is only 100 nanoliters, a higher concentrated insulin (U500) should be used. This enables longer refill cycles of the implantable insulin reservoir to be realized.

Can you explain in simple terms how the device works?
I am describing our dream here, which we will only have realized once we have successfully completed clinical certification, including a clinical study, at the end of the project: patients who wear our implant in their abdomen will no longer notice their illness. Our multi-parameter sensor regularly measures not only blood sugar, but also ketone (3bêta hydroxy-butyrate) and lactate. This means that blood sugar can be regulated much more precisely. The algorithm then sends its dosing signal to the micropump, which doses a U500 insulin in tiny amounts from a reservoir near the liver through the peritoneal space in the abdomen. By administering this faster via the peritoneum close to the liver, we can manage the blood sugar level much better with minimal patient input, e.g. no need to announce meal intakes. The patient will not notice any of this. The insulin is refilled every three months with a syringe via a fluid port. And the battery only runs out after 10 years and has to be replaced by a small operation. That means a syringe every three months and a small operation every 10 years - that is the rest of the burden for the patient.

What is the impact of human factors on the research conducted within MuSiC4Diabetes?
The human factor is crucial for the development of this medical product in particular. With this innovation, we want to reduce the burden on patients as much as is technically possible. Only if we ask patients at an early stage of the project can we take these requirements into account and incorporate them into the development. We are therefore very happy that we have FIDAM, an absolute specialist in the human factor, as a project partner. This gives us very valuable information, for example information on how long the implant's battery life must be at least. There is very different feedback here: while parents of children with type 1 diabetes want very long battery life, adult type 1 patients would also accept a product with a shorter battery life. This gives us valuable information for the dimensioning of our system.

What are the possible future applications of the device developed within the MuSiC4Diabetes project?
Our system is of course intended for the treatment of people living with insulin-treated diabetes. We are initially focusing on adults living with type 1 diabetes. In a later expansion stage, we can also think about resizing this system for children with type 1 diabetes, if miniaturization is further successful and the battery life is extended. If this system is successful among patients living with type 1 diabetes and is accepted by both patients and health insurance companies, we could consider using it to treat people with insulin-treated type 2 diabetes in the long term.

Individual components such as the micropump can of course also be considered for completely different applications, both in the field of medicine and diagnostics (implants for treating tumors or glaucoma, or organ-on-chip applications), as well as outside of it (gas sensor systems, oil dosing systems, fragrance dosing systems).

Discover the MuSiC4Diabetes consortium supporting this ambitious vision.