Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry

Korábbi kezelés

• Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment

Más betegség

• Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
• Severe diabetes related complications (i.e. macro angiopathy, severe micro angiopathy, severe neuro-, retino- or nephropathy) when unstable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy
• Known severe tape reactions or allergies
• Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, tremor, language barriers, alcohol or drug misuse

Laborértékek

• Have extensive skin changes/diseases at the proposed measurement site (wrist and upper arm for FreeStyle Libre 3) that could interfere with the accuracy of glucose measurements.

Egyéb

• Hypoglycemia unawareness
• Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy)
• Not able to understand, write or read German
• Dependency from the sponsor or the clinical investigator

• Clinical diagnosis of type 1 OR type 2 diabetes OR no diabetes
• For subjects with diabetes: glycated haemoglobin (HbA1c) <10%
• Age ≥ 18 years
• Male or female or diverse
• An understanding of and willingness to follow the protocol
• Signed informed consent