NCT04935957

Study of GLUCUBE Performance, a Non-invasive System for Monitoring Blood Glucose Levels Based on Near Infrared Spectroscopy (NIRS) Technology.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: iGluco · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is a prospective, single center, non-interventional, open label clinical investigation. The primary objective of the study is to evaluate the performance of GLUCUBE system compared to the standard glucometer in the determination of blood glucose level in adult patients.

Detailed description

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 GLUCUBE device 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. This study is a prospective, single center, non-interventional, open label clinical investigation designed with a total amount of 105 subjects. Study participants will take the GLUCUBE device and standard glucometer home and each subject will take 4 pairs of measurements per day for a week.

Conditions

• Blood Glucose

Interventions

Type	Name	Description
DEVICE	GLUCUBE device	device to monitor and measure the blood glucose compared to the standard glucometer in a group subjects

Timeline

• Start date: 2024-03-11
• Primary completion: 2024-05-15
• Completion: 2024-05-15
• First posted: 2021-06-23
• Last updated: 2024-09-19

Locations

1 site across 1 country: Spain