It will be a radically new approach for long-term continuous monitoring of insulin-treated persons with diabetes (ITD) moving from a glucose-only to a multi-metabolite monitoring - glucose, lactate and 3 ß OH-butyrate– paradigm. Multi-metabolite monitoring will also lead to a diabetes therapy breakthrough by algorithmically driving a continuous physiologic insulin delivery by a maintenance-free implanted MEMS pump using the peritoneal route enabling an optimal therapy for subjects with ITD. Our vision is a fully implantable artificial organ to replace insulin secretion loss by targeting metabolic health instead of mere glucose control and mimicking physiological insulin action. While offering a really burden-free life for insulin-treated children and adults, it is expected to allow a dramatic reduction of metabolic variations, hence a minimization of acute and long-term complications and an abating of the still high mortality of T1D patients. Unobtrusive living with diabetes will be reached by the calibration-free, implantable, long-term multi-metabolite monitoring solution connected wirelessly to a novel highly miniaturized silicon MEMS micropump, with down to 50 nl stroke volume, able to operate a newly developed U1000 insulin and enabling reservoir refill cycles of 180 days up to 365 days. Both devices hold durable battery operating life of more than 8 years without recharge and are suitable for children. Newly designed control algorithms based upon multiple signal inputs will drive automated insulin delivery without the need of obtrusive meal and physical exercise announcements.

"Diabetes is the #1 health challenge of the 21st century. Continuous Glucose Monitoring or CGM ($1.25B market in 2016, growing 29%/yr) is today’s cornerstone of “diabetes self-management” and the most effective solution to reduce the economic and societal burden of diabetes. But the shortcomings of current CGMs hinder their wider adoption: high cost, unsatisfactory predictability of severe events, and poor user comfort. The DiaMOND project will remove these barriers by bringing needle-free, low-cost Continuous Diabetes Monitoring to market. DiaMOND is specifically geared at extending Indigo’s current CGM with reliable severe clinical event prediction and a great user experience; demonstrating the reliability in a first-in-man trial; creating market acceptance by involving Key Opinion Leaders; and obtaining reimbursement. Indigo will be ready for a large pivotal clinical study and CE marking after completing the DiaMOND project. DiaMOND will accelerate Indigo’s CDM market access by 2-3 years."