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

Blood Glucose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04935957
• Other study ID #: DIA-2021-01
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: iGluco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Glucose

Intervention

Device:
• GLUCUBE device
device to monitor and measure the blood glucose compared to the standard glucometer in a group subjects

Locations

Country	Name	City	State
Spain	Centro de Salud La Algaba	La Algaba	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
iGluco

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User satisfaction	Patient reported satisfaction related to the investigational device: in a 1 to 10 scale: 1 - Disagree, 10 - Agree.; And, if given the choice, will you use GLUCUBE device again? Yes or No	8 days after the participant enters the study
Primary	Performance Evaluation	GLUCUBE system performance in the monitoring and measurement of the blood glucose compared to the standard glucometer (blood capillary glucometer - Bayer Contour®Next).; Each pair of measurements includes one measurement with the standard glucometer (Bayer Contour®Next) and one measurement with GLUCUBE device.	4 times/day for 1 week
Primary	Safety Evaluation	All (Serious) Adverse Events and GLUCUBE device related adverse events: local and systemic effects of GLUCUBE device, and the standard glucometer, including, but not limited to redness, burns, pain, or other complications such as bleeding or local infection will be collected.	All AE will be collected during participation in the study since V1 at V2 (8 days)
Secondary	Performance Evaluation	GLUCUBE system performance in the monitoring and measurement of the blood glucose compared to the standardized POC device for the determination of glucose (Accu-Chek® Inform II system).; Each pair of measurements includes one measurement with standardized POC device for the determination of glucose (Accu-Chek® Inform II system) and one measurement with GLUCUBE device.	through study completion, an average of 8 days