Indigo Diabetes NV is proud to announce the successful completion of the SHINE Study, a six-month feasibility trial of our implantable continuous multi-metabolite monitor — designed to measure glucose, ketone, and lactate concentrations in real time.
By eliminating the need for external wearables and delivering continuous, multi-metric insights, this innovation positions Indigo as a frontrunner in the $100B+ global diabetes care market.
Unlike traditional glucose-only monitors, Indigo’s technology captures additional key metabolic markers:
- Ketones offer early detection of ketosis and diabetic ketoacidosis (DKA), helping users and clinicians intervene before complications arise.
- Lactate serves as an indicator of metabolic stress, exercise intensity, and potential hypoxia—offering broader insights into overall metabolic health.
Key findings from the SHINE Study include:
- A strong safety profile with no device-related serious adverse events
- Robust technical feasibility for long-term, continuous spectral monitoring
- Positive patient-reported usability in real-world, at-home settings
Conducted under MDR 2017/745 and ISO 14155:2020, the study confirmed that our technology can reliably collect spectral data over extended periods. Feedback from participants underscored the benefits of a discreet, low-burden alternative to traditional wearable sensors.
This milestone marks a significant step forward in the evolution of next-generation diabetes and metabolic care. With strong early performance data, unique multi-analyte capabilities, and a clear path to regulatory advancement, Indigo is shaping the future of diabetes management.