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

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 are pregnant, planning on becoming pregnant or nursing
• •Coagulation 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 women
• •The presence of any other active implanted device
• •The presence of any other CGM sensor or transmitter located in lower abdomen or back (other location is acceptable)
• •Waist circumference of \>120 cm
• •Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.