EU funding is helping two companies from the Twente region of the Dutch province of Overijssel – artificial pancreas manufacturer Inreda Diabetic and microneedle systems producer U-Needle – to develop the Microneedle Artificial Pancreas system in collaboration with the University of Twente. It will allow people with type 1 diabetes to regulate their blood sugar levels after meals more quickly and easily than with existing methods such as insulin pumps.
- 18 May 2020
The Inreda artificial pancreas gives you back freedom of mind so you can think of other things than just sugar, eating, measuring, etc. It gives you back your life. I have been wearing the device for a year now and I really feel healthy.
The main focus of the project is the integration of two innovative technologies – the Inreda artificial pancreas and the U-Needle microneedle – to create the Microneedle Artificial Pancreas. This automatically measures blood sugar and infuses the hormones insulin or glucagon using microneedles as thin as an average human hair and 1 mm long, compared with 6 to 9 mm for most similar systems.
Sensors tell the device how much glucose is in the blood and whether the level is increasing or decreasing. If the level is too high or low, the needles deliver the required amounts of insulin or glucagon to the body: the former to lower blood sugar, the latter to raise it.
Speed and comfort
Producers of devices for diabetes care are constantly looking for faster ways of getting insulin and glucagon into the bloodstream. Currently available systems usually inject them into the subcutaneous fat layer: the innermost layer of the skin. The Microneedle Artificial Pancreas infuses them through the dermis: the layer between the epidermis (the outermost layer) and the subcutaneous tissue. As the dermis has more blood vessels than the subcutaneous fat layer, the hormones enter the blood and adjust the glucose level faster.
Due to their shorter length, the microneedles are more comfortable for diabetics and less likely to cause skin irritations. Also, they can be used for 7 days, whereas typical needles must be replaced every 3 days. In addition, as the device regulates glucose levels autonomously 24 hours a day, users do not need to count and record the amount of carbohydrates they consume or to calculate the quantity of insulin they need and inject it themselves.
Prototype trials
Prototypes of the Microneedle Artificial Pancreas are to be tested in the Rijnstate hospital at Arnhem. If they work as intended, additional trials involving people with type 1 diabetes will follow, to make the device completely reliable and as user-friendly and affordable as possible.
CE certification, which proves that a product conforms to relevant standards and authorises its sale within the European Economic Area, is expected for the current Inreda artificial pancreas model (which does not include microneedles) no later than May 2020. Along with the model used for clinical trials and gaining the CE mark, a smaller, lighter version of the system is being developed to further enhance comfort for people living with diabetes.
With the first steps towards approval and commercialisation being taken and with 45 million people worldwide suffering from type 1 diabetes, the size of the target market for and the job-creation potential of the Microneedle Artificial Pancreas are considerable.
To underline this potential, the Inreda artificial pancreas was chosen from more than 50 entries by an expert jury as one of the Netherlands’ three National Icons for 2019. Run by the Dutch Ministry of Economic Affairs and Climate Policy, the National Icons competition recognises the country’s most innovative ideas and provides support over the following years so that the ambitions arising from these ideas can be achieved.
Total investment and EU funding
Total investment for the project “Microneedle Artificial Pancreas system for postprandial glucose control – the artificial pancreas of the future” is EUR 3 553 766, with the EU’s European Regional Development Fund contributing EUR 782 545 through the “East Netherlands” Operational Programme for the 2014-2020 programming period. The investment falls under the priority “Research and innovation”.