Study of the Performance of the GLUCUBE System in Patients With Type 2 Diabetes

Study of the Performance of the GLUCUBE System in Patients With Type 2 Diabetes

This study is a prospective, single center, open label clinical investigation. The primary objective of the study is to evaluate the performance of GLUCUBE in patients with diabetes type 2 and how the accuracy of the system improves as the time of use by the patient increases.

Current methods of measuring blood glucose, glucometers, although minimally invasive, can be painful as they require puncturing the fingertip with a prick device and drawing a drop of blood, which is applied to a disposable test strip. This minimal invasiveness can cause discomfort and discourage the user from testing their blood glucose levels as frequently as necessary, leading to poor glycemic control. Due to the non-invasive nature of the GLUCUBE system, it provides glucose level information safely and painlessly, avoiding any discomfort to the user. It is low cost as it uses commonly used electronic components and does not require test strips or other consumables that would increase the ongoing cost of the device. The performance of the GLUCUBE system has already been evaluated in comparison to the standard glucometer (Ascensia Contour®Next) in adult patients with and without diabetes. The primary objective of this clinical investigation is to evaluate the performance of GLUCUBE in patients with diabetes type 2 and how the accuracy of the system improves as the time of use by the patient increases.

Inclusion Criteria:

• Be ≥ 18 years of age.
• Diagnosed with type 2 diabetes mellitus.
• Have a smartphone with an internet connection that allows the installation of the GLUCUBE APP.
• Be able to use the GLUCUBE system autonomously, in the opinion of the researcher.
• Have signed the informed consent.

Exclusion Criteria:

• The patient is currently participating in another clinical investigation or has participated in another clinical investigation in the last 30 days prior to the start of this study.
• Pregnant or breast-feeding women and those subjects who plan pregnancy during the clinical investigation follow-up period.
• Presence of other anatomical or comorbid conditions, or other medical, social or psychological conditions that, in the opinion of the investigator, could limit the subject's ability to participate in the clinical investigation or to comply with the follow-up requirements, or affect the scientific soundness of the clinical investigation results.
• Patients with any active and/or infectious acute illness.
• Patients who have a condition that affects blood circulation in the fingers of the hand, such as Raynaud's phenomenon.
• Any medical condition that, in the opinion of the investigator, will increase the risk of hyperglycemic and hypoglycemic events: seizures, heart disease, unconscious hypoglycemia, etc.
• Patients with an inability to maintain hand stability during measurement or with progressive nervous system disease affecting movement (Parkinson's disease, moderate-severe essential tremor, and other diseases with involuntary movements).
• Patients suffering from calluses, malformations, or open wounds with bandages on their hands.
• Patients with nail polish or any type of false nail.