Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-29 @ 5:19 AM
Study NCT ID:
NCT07039357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without Diabetes
Sponsor:
Glyconics Ltd
Organization:
Study Overview
Official Title:
A Single Centre, Open-label Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With or Without Known T2DM: a Confirmatory Performance Evaluation of the Glyconics SW Package Delivering the Dichotomised Screening Test Results in a Known Population.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
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:
ANODE04
Brief Summary:
A single-site, open label, confirmatory study assessing two biomarkers indicative of levels of glycaemia; glycated keratin in fingernails and glycated haemoglobin (HbA1c). Screening for diabetes
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?: