Study to Evaluate a Prototype Non-Invasive BG Measurement System

Exclusion Criteria

• •The patient may not enter the study if ANY of the following apply:
• •Type 1 patients diagnosed after age 29 Type 2 patients with positive GAD antibody test results Patient with other active implantable medical devices, such as pacemakers Patient who is currently participating in another clinical trial for a pharmaceutical product Patient with a history of allergy to any materials used in the prototype sensors or materials used to stabilise the devices or cabling including Rocktape, double-sided tape and prosthetic adhesive Female patient who is pregnant or lactating
• •Patient with any injury or infection of the wrist
• •Patient who is unwilling or unable to attend each visit fasting from midnight (water is permitted freely) or fasting for a minimum of 3 hours (for an afternoon session)
• •Patient who takes paracetamol or aspirin in the 24 hours preceding each visit
• •Patient with clinically significant abnormal values in clinical chemistry, as judged by the PI
• •Concurrent illness or a condition that may interfere with blood glucose levels (e. g. carcinoma, haematological disease, vasculitis, connective tissue disease, alcohol neuropathy)
• •Patient who is incapable of giving informed legal consent
• •Recent (1 month) episode of DKA, HONK or severe hypoglycaemia
• •Patient on pramlintide (Symlin/Tripro-Amylin)
• •Patient who attends the visit under the influence of alcohol or recreational drugs
• •Patient with severe macrovascular disease - stroke, CVD, CKD stage IV -V Patient who fails screening for alcohol and recreational drugs use.