Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT06035367
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2023-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes
Sponsor:
Eclypia
Organization:
Study Overview
Official Title:
SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: