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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLUCUBE device | Device | device to monitor and measure the blood glucose compared to the standard glucometer in a group subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud La Algaba | La Algaba | Sevilla | 41980 | Spain |
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