Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-03-09 @ 7:04 AM
Study NCT ID:
NCT05198895
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2021-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Performance of the Glyconics-SX System
Sponsor:
Glyconics Ltd
Organization:
Study Overview
Official Title:
A Single-centre, Open-label Study Testing the Safety and Performance of the Glyconics-SX System in Individuals With or Without Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
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:
ANODE01
Brief Summary:
The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or assumed clinical status of the participants and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with validated, comparator device.
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?: