Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-01-08 @ 6:55 PM
Study NCT ID:
NCT03352518
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2017-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device
Sponsor:
RSP Systems A/S
Organization:
Study Overview
Official Title:
Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device
Status:
COMPLETED
Status Verified Date:
2017-11
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:
None
Brief Summary:
This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.
Detailed Description:
Subjects will collect spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.
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?: