Clinical trial NCT04935957: Study of GLUCUBE Performance, a Non-invasive System for Monitoring Blood Glucose Levels Based on Near Infrared Spectroscopy (NIRS) Technology.
Official title: Study of GLUCUBE Performance, a Non-invasive System for Monitoring Blood Glucose Levels Based on Near Infrared Spectroscopy (NIRS) Technology.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Lead sponsor: iGluco
Sponsor class: INDUSTRY
First posted: 2021-06-23
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Performance Evaluation
timeFrame: 4 times/day for 1 week
measure: Safety Evaluation
timeFrame: All AE will be collected during participation in the study since V1 at V2 (8 days)
Secondary outcomes:
measure: Performance Evaluation
timeFrame: through study completion, an average of 8 days
Other outcomes:
measure: User satisfaction
timeFrame: 8 days after the participant enters the study
Locations:
city: La Algaba
country: Spain
facility: Centro de Salud La Algaba
state: Sevilla
Study officials:
References: