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Diabetes is one of the very common and chronic diseases in the present world, which affects children and adults. Diabetes is characterized by hyperglycemia. Hence, diabetic patients need to precisely monitor their blood sugar level regularly a few times a day. Currently, the solutions for self-monitoring blood glucose are invasive (finger prick method, continuous glucose monitoring (CGM) using microneedle).The fully non-invasive CGM approaches still are in high demand.
The medical device is developed, ultimately, to continuously measure the blood glucose level from continuous in-vivo photoacoustic signal.
For this study, the goal is to check if the signal collected by the investigational device is relevant and exploitable in patients with type I diabetes.
The main task of participants is to wear the investigational device during one week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal | Experimental | Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive continuous monitoring device to record photoacoustic signal | Device | Neogly is in two parts, the measurement head, to be worn on the wrist and the power box, to be worn on the forearm or upper arm. The ribbon cable makes the connection between the two parts. A handset is used to start/stop the device. The medical device record a continuous photoacoustic signal. |
| Measure | Description | Time Frame |
|---|---|---|
| Value of absolute photoacoustic signal on the participant arm | The first endpoint is evaluated by the value of photoacoustic signal on the participant arm. To check if if the photoacoustic data of the investigational device are relevant and exploitable. This signal should be above a given threshold, corresponding to an absolute photoacoustic value at least three times higher than this measured when the device is not worn. | around one week (7 to 9 days) |
| Measure | Description | Time Frame |
|---|---|---|
| assess the safety by the general clinical evaluation (normal, abnormal, abnormal not clinically significant) | baseline (V1) and after the device wearing (V2) | around one week (7 to 9 days) |
| assess the safety by number/class of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eclypia | Contact | 33476767383 | contact@eclypia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble Alpes | Recruiting | Grenoble | 38043 | France |
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| ID | Term |
|---|---|
| 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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|
definitions of AE from European Medical Device Regulation 2017/745
| during one week (7 to 9 days) |
| assess the tolerability of the investigational device by a usability questionnaire | some questions with scales from 1 to 10 (no total score) and other questions with a free field to collect the user feedback about the size, appearance, comfort, operation of the device and the suggestions for device improvement | around one week (7 to 9 days) |