The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects

Inclusion Criteria: * Subjects willing to sign an informed consent form (ICF) * Adult subjects, age ≥ 18 * Subjects willing to comply to study protocol requirements (study visits with frequent venous blood sampling and deliberate insulin, glucose, ketone and lactate (sub study only) challenges) * Subjects willing to wear a Dexcom G6 CGM during duration of the study * Subjects willing to charge the FUSHO SENSOR/ED and CHARGER on daily basis * Patients with type 1 diabetes mellitus (T1DM) according to WHO criteria, diagnosed for at least 12 months prior to screening, on Multiple Daily Injections (MDI), not on insulin pump treatment during the course of the study * Patients with type 2 diabetes mellitus (T2DM) on Intensive Insulin Therapy (IIT), with a minimum of four injections per day and known dosing parameters Exclusion Criteria: * Known allergy to PDMS * Subjects with a contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, untreated hypothyroidism) * History of severe hypoglycaemia in the previous 6 months. Severe hypoglycaemia is defined as hypoglycaemia resulting in loss of consciousness or seizure * History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months * History of, hepatitis C or HIV or other disease transmissible by blood * A condition requiring or likely to require magnetic resonance imaging (MRI) during the study duration * Female subjects who…