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

The objectives of SHINE study are to confirm the safety aspects of the SHINE SYSTEM. Moreover, the goal of this clinical investigation is the initial evaluation of sensor's performance by assessing sensor's ability to qualitatively detect the appropriate analytes in subjects with diabetes of 18 years and older.

Inclusion Criteria:Subjects willing to sign an informed consent form (ICF)Adult subjects, age ≥ 18Subjects 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 studySubjects willing to charge the FUSHO SENSOR/ED and CHARGER on daily basisPatients 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 studyPatients with type 2 diabetes mellitus (T2DM) on Intensive Insulin Therapy (IIT), with a minimum of four injections per day and known dosing parametersExclusion Criteria:Known allergy to PDMSSubjects 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 seizureHistory of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 monthsHistory of, hepatitis C or HIV or other disease transmissible by bloodA condition requiring or likely to require magnetic resonance imaging (MRI) during the study durationFemale subjects who are pregnant, planning on becoming pregnant or nursingCoagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor are allowed).Anemia identified by a haemoglobin <14 g/dL for men or <12 g/dL for womenThe presence of any other active implanted deviceThe presence of any other CGM sensor or transmitter located in lower abdomen or back (other location is acceptable)Waist circumference of >120 cmAny disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.