Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device and Evaluation of the Instructions for Use

Inclusion Criteria: * Male and female subjects ≥18 years of age * Individuals diagnosed with type 1 diabetes. Gestational diabetes excluded * Skin phototype 1-4 * Willing to perform up to 12 finger sticks during each day of out-patient measurements and up to 40 finger sticks at the two in-clinic study days * Wireless internet connection at home to be used in the study Exclusion Criteria: * For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice NCA approved birth control during the study duration * For female subjects: breastfeeding * Subjects currently participating in another study * Subjects not able to understand and read German * In investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol * Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease) * Extensive skin changes, tattoos or diseases on right hand thenar (sensor application site) * Known allergy to medical grade alcohol * Hemodialysis * Systemic or topical administration of glucocorticoids at the right hand for the past 7 days or during the study period expected * Medical history or any condition that may, in the opinion of the investigator compromise the subject's ability to participate * Comorbidity or concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff * Severe diabetes related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s) * Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families) * Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment * Hypoglycemia unawareness * Subjects who have participated in the study IDT-1639-RO