NCT07075796

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: iGluco · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	GLUCUBE system	A non-invasive system to monitor and measure the blood glucose compared to the standard glucometer in a group subjects

Timeline

• Start date: 2025-06-02
• Primary completion: 2025-11-28
• Completion: 2025-11-28
• First posted: 2025-07-20
• Last updated: 2026-01-13

Locations

1 site across 1 country: Spain