The GLOW Study - The YANG System

Exclusion Criteria

• •Subjects with a contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, hypothyroidism, known allergic reaction to ibuprofen/paracetamol/acetylsalicylic acid)
• •For people with diabetes: History of severe hypoglycaemia in the previous 6 months. Severe hypoglycaemia is defined as hypoglycaemia resulting in loss of consciousness or seizure
• •For people with diabetes: History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
• •Any blood disorder identified by haematocrit \<30% or \>55%
• •History of hepatitis B, hepatitis C, or HIV
• •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
• •Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
• •Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication
• •Any long-term drug treatments other than insulin, such as statins, low-dose aspirin, fibrates etc.
• •The presence of any other active implanted device except for insulin pumps (as defined further in protocol)
• •The presence of any other CGM sensor or transmitter located in abdomen (other location is acceptable)
• •Impaired fasting glucose or impaired glucose tolerance (for healthy volunteers)
• •Any contraindication to the use of the Yang system as listed in the device IFU (i.e. any known allergy to PDMS)