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

NCT04935957 | Completed

• 1 other identifier: DIA-2021-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Glucose

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Performance Evaluation

  through study completion, an average of 8 days

Other Outcomes (1)

• User satisfaction

  8 days after the participant enters the study

Study Arms (1)

Non-interventional. Open Label.

OTHER

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

Device: GLUCUBE device

Interventions

GLUCUBE device DEVICE

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

Also known as: GLUCUBE

Non-interventional. Open Label.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥ 18 years old.
• Have a smartphone with an internet connection that allows the installation of GLUCUBE APP
• Have signed the informed consent.

You may not qualify if:

• 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.
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
• 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.
• Patients with any acute active and/or infectious disease.
• Patients who have a condition that affects blood circulation in the fingers of the hand, such as Raynaud's phenomenon.
• Any medical condition that, by the investigator judgment, will increase the risk from hyper and hypoglycemic event: seizures, heart disease, hypoglycemia unawareness, etc.
• Patients who, in the opinion of the investigator, do not have sufficient manual dexterity to perform the tests themselves.
• 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).
• Patients suffering from calluses, malformations, or open wounds with bandages.
• Patients with nail polish or any type of false nail.
• Subjects who do not understand or cannot follow the Procedures Involved in the Use of the Device Under Investigation.

Sponsors & Collaborators

• iGluco: lead

Study Sites (1)

Centro de Salud La Algaba

La Algaba, Sevilla, 41980, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 23, 2021
• Study Start: March 11, 2024
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

ES (1)