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

NCT ID: NCT04935957

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2024-05-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Non-interventional. Open Label.

GLUCUBE system performance in the monitoring and measurement of the blood glucose compared to the standard glucometer (blood capillary glucometer - Bayer Contour®Next).

Group Type: OTHER

GLUCUBE device

Intervention Type: DEVICE

device to monitor and measure the blood glucose compared to the standard glucometer in a group subjects

Interventions

GLUCUBE device

device to monitor and measure the blood glucose compared to the standard glucometer in a group subjects

Intervention Type: DEVICE

Other Intervention Names

GLUCUBE

Eligibility Criteria

Inclusion Criteria

1. Be ≥ 18 years old.

2. Have a smartphone with an internet connection that allows the installation of GLUCUBE APP

3. Have signed the informed consent.

Exclusion Criteria

1. Subject is currently participating in another clinical investigation or has participated in another clinical investigation in the past 30 days prior to the start of the present study.

2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.

3. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

4. Patients with any acute active and/or infectious disease.

5. Patients who have a condition that affects blood circulation in the fingers of the hand, such as Raynaud's phenomenon.

6. Any medical condition that, by the investigator judgment, will increase the risk from hyper and hypoglycemic event: seizures, heart disease, hypoglycemia unawareness, etc.

7. Patients who, in the opinion of the investigator, do not have sufficient manual dexterity to perform the tests themselves.

8. Patients with an inability to maintain stability of the hand during measurement or with progressive disease of the nervous system that affects movement (Parkinson's disease, moderate-severe essential tremor, and other diseases with involuntary movements).

9. Patients suffering from calluses, malformations, or open wounds with bandages.

10. Patients with nail polish or any type of false nail.

11. Subjects who do not understand or cannot follow the Procedures Involved in the Use of the Device Under Investigation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

iGluco

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro de Salud La Algaba

La Algaba, Sevilla, Spain

Countries

Spain

Other Identifiers

DIA-2021-01

Identifier Type: -

Identifier Source: org_study_id