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This study is a prospective, single center, open label clinical investigation. The primary objective of the study is to evaluate the performance of GLUCUBE in patients with diabetes type 2 and how the accuracy of the system improves as the time of use by the patient increases.
Current methods of measuring blood glucose, glucometers, although minimally invasive, can be painful as they require puncturing the fingertip with a prick device and drawing a drop of blood, which is applied to a disposable test strip. This minimal invasiveness can cause discomfort and discourage the user from testing their blood glucose levels as frequently as necessary, leading to poor glycemic control. Due to the non-invasive nature of the GLUCUBE system, it provides glucose level information safely and painlessly, avoiding any discomfort to the user. It is low cost as it uses commonly used electronic components and does not require test strips or other consumables that would increase the ongoing cost of the device. The performance of the GLUCUBE system has already been evaluated in comparison to the standard glucometer (Ascensia Contour®Next) in adult patients with and without diabetes. The primary objective of this clinical investigation is to evaluate the performance of GLUCUBE in patients with diabetes type 2 and how the accuracy of the system improves as the time of use by the patient increases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 system | Device | A non-invasive system to monitor and measure the blood glucose compared to the standard glucometer in a group subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance Evaluation | Performance of the GLUCUBE device in monitoring and measuring blood glucose in adult patients with type 2 diabetes, compared to the standard glucometer (capillary blood glucometer - Ascensia Contour®Next). | 4 times/day for 1 week |
| Performance Improvement Evaluation | Improved performance of the GLUCUBE device as patient usage time increases. | through study completion, an average of 21 days |
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| Measure | Description | Time Frame |
|---|---|---|
| User Satisfaction | Evaluation of patient preferences for using the GLUCUBE system versus a capillary glucometer. Device(s) to be used in clinical research. | 21 days after the participant enters the study |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Especialidades Virgen de los Reyes. Hospital Universitario Virgen del RocĂo | Seville | Seville | 41001 | Spain |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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