The current methods for blood glucose measurements, glucometers, although minimally invasive, can be painful, requiring puncturing the fingertip with a lancet device and removing a drop of blood, that applies to a disposable test strip. This minimal invasiveness may cause discomfort and deter the user from measuring his/her blood glucose levels as frequently as required. Due to igluco invincit non-invasive nature, it is expected to give the patient or health care provider immediate reliable quantitative as well as qualitative information, safely and painlessly avoiding any type of discomfort to the user. Therefore, the primary objective is to evaluate the performance of igluco invincit device, in the monitoring and measurement of the blood glucose level in adult patients with stable Diabetes Mellitus type 1 and 2, compared to the standard glucometer (blood capillary glucometer - Bayer, Contour XT). This performance will be measured by Clarke Error. The secondary objective is to revise all Serious Adverse Events and local and systematic effects of igluco invincit and the standard glucometer, including: redness, burns, pain, or other complications such as bleeding or local infection.~This study is an Interventional, prospective, single center, controlled, single-arm, non-randomized, open label clinical study clinical investigation designed with a total amount of 105 subjects that will be enrolled in the investigation. Study participants will take the igluco invincit and standard glucometer home and each subject will take 4 pairs of measurements per day for a week.
This study is an Observational, prospective, single center, controlled, single-arm, non-randomized, open label clinical study clinical investigation designed to evaluate the performance of igluco invincit in the monitoring and measurement of the blood glucose compared to the standard glucometer in a group of controlled diabetic subjects. The evaluation of the clinical performance including sensitivity, specificity, and accuracy will be also carried out.~The clinical investigation has been designed to involve as little pain, discomfort, fear, and any other foreseeable risk as possible for subjects.