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

Last updated: September 4, 2024
Sponsor: iGluco
Overall Status: Completed

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Treatment

GLUCUBE device

Clinical Study ID

NCT04935957
DIA-2021-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be ≥ 18 years old.

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

  3. Have signed the informed consent.

Exclusion

Exclusion Criteria:

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

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

  3. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation 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 thehand, such as Raynaud's phenomenon.

  6. Any medical condition that, by the investigator judgment, will increase the riskfrom hyper and hypoglycemic event: seizures, heart disease, hypoglycemiaunawareness, etc.

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

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

  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 Useof the Device Under Investigation.

Study Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: GLUCUBE device
Phase:
Study Start date:
March 11, 2024
Estimated Completion Date:
May 15, 2024

Study 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.

Connect with a study center

  • Centro de Salud La Algaba

    La Algaba, Sevilla 41980
    Spain

    Site Not Available

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