Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-05 @ 11:37 PM
Study NCT ID:
NCT04060693
Status:
WITHDRAWN
Last Update Posted:
2023-11-18
First Post:
2018-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin
Sponsor:
RSP Systems A/S
Organization:
Study Overview
Official Title:
Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin
Status:
WITHDRAWN
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Miscommunication with the CRO that was hired to help with the regulatory submission process
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:
The subjects enrolled in this protocol will dedicate 30 days of home-based measurement, scheduled within a 40 days' time frame. For reference measurements, subjects will be equipped with a blood glucose meter (Contour Next One, Ascenia). Optical measurements are collected with the investigational medical device. Each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a blood glucose meter and two investigational medical device measurements.
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?: