Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512077
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Clinical Validation of mμSORS for Non-invasive Blood Glucose Detection in Non-diabetic Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Validation of Multi-channel Microspatial Offset Raman Scattering Spectroscopy mμSORS for Non-invasive Blood Glucose Detection in Non-diabetic Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center open-label prospective study Blood glucose is measured at different time points during oral glucose tolerance test and hypoglucose clamp test in healthy subjects using both venous plasma and multi-channel microspatial offset Raman scattering spectroscopy mμSORS Venous plasma glucose was set as gold standard The two measurements were collected synchronously so as to calculate the mean absolute relative difference MARD and the consensus error grid CEG Accuracy of non-invasive blood glucose testing by mμSORS will be in-depth validated specifically in the 3-10 mmoll glucose range
Detailed Description:
In order to clinically verify the accuracy and safety of non-invasive blood glucose measurement by the mμSORS technology specifically in the 3-10 mmoll glucose range this study will conduct oral glucose tolerance tests and hypoglucose clamp tests on healthy subjects at different time points during the tests In oral glucose tolerance tests there will be 9 points as follows 0-min and post glucose-load 30-min 60-min 90-min 120-min 150-min 180-min 210-min and 240-min While in hypoglucose clamp tests blood glucose will be set at around 30-40mmoll for about 15-20 hours blood glucose will be detected every 10 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None