SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes
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|ClinicalTrials.gov Identifier: NCT06035367|
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Device: Non-invasive continuous monitoring device to record photoacoustic signal||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes|
|Actual Study Start Date :||July 6, 2023|
|Estimated Primary Completion Date :||October 30, 2023|
|Estimated Study Completion Date :||October 30, 2023|
Experimental: Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal
Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal
Device: Non-invasive continuous monitoring device to record photoacoustic signal
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.
- Value of absolute photoacoustic signal on the participant arm [ Time Frame: around one week (7 to 9 days) ]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.
- assess the safety by the general clinical evaluation (normal, abnormal, abnormal not clinically significant) [ Time Frame: around one week (7 to 9 days) ]baseline (V1) and after the device wearing (V2)
- assess the safety by number/class of adverse events [ Time Frame: during one week (7 to 9 days) ]definitions of AE from European Medical Device Regulation 2017/745
- assess the tolerability of the investigational device by a usability questionnaire [ Time Frame: around one week (7 to 9 days) ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035367
|CHU Grenoble Alpes||Recruiting|
|Grenoble, France, 38043|
|Contact: Centre d'investigation clinique Centre d'investigation clinique 334.76.767.575 CIC@chu-grenoble.fr|
|Principal Investigator: Pierre-Yves Pr BENHAMOU, principal investigator|