Adaptation and Validation Protocol for the Clinical Use of a Non-invasive Sensor for Blood Glucose Level Determination

Study Overview
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Brief Summary
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This study is an Observational, prospective, single center, controlled, single-arm, non-randomized, open label clinical study clinical investigation designed to evaluate the performance of GLUCUBE device in the monitoring and measurement of the blood glucose compared to the standard glucometer in a group of controlled diabetic subjects. The evaluation of the clinical performance including sensitivity, specificity, and accuracy will be also carried out. The clinical investigation has been designed to involve as little pain, discomfort, fear, and any other foreseeable risk as possible for subjects.

Detailed Description
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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. Therefore, the primary objective is to evaluate the performance of GLUCUBE device, in the monitoring and measurement of the blood glucose level in adult patients with stable Diabetes Mellitus type 1 and 2, compared to the standard glucometer (blood capillary glucometer - Bayer, Contour XT). This performance will be measured by Clarke Error. The secondary objective is to revise all Serious Adverse Events and local and systematic effects of GLUCUBE device and the standard glucometer, including: redness, burns, pain, or other complications such as bleeding or local infection. This study is an Interventional, prospective, single center, controlled, single-arm, non-randomized, open label clinical study clinical investigation designed with a total amount of 105 subjects that will be enrolled in the investigation. Study participants will take the iGluco device and standard glucometer home and each subject will take 4 pairs of measurements per day for a week.

Official Title
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Study of the Clinical Precision of a Non-invasive Device Based on NIRS (Near Infrared Spectroscopy) Technology for the Determination of Blood Glucose Levels With GLUCUBE Device

Conditions
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Diabetes Mellitus Type 1 and 2

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must provide written informed consent prior to any clinical investigation related procedure. Be ≥ 18 years old. Patients with controlled type 1 or type 2 Diabetes Mellitus. Exclusion Criteria: 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 Any medical condition that, by the investigator judgment, will increase the risk from Hyper and Hypo-Glycemic experiment: 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. Patients suffering from calluses, malformations or open wounds with bandages and patients with nail polish or ceramic nails and rings. Subjects who do not understand or cannot follow the procedures involved in the use of the device under investigation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single-group<br>Male and female adult subjects with controlled diabetes 1 and 2. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fingertip capillary blood glucose quantitative measurement. | The level of blood glucose (mg/dl) will be measured by GLUCUBE device and Bayer, Contour XT glucometer. | 4 times/day for 1 week |