Clinical Validation of mμSORS for Non-invasive Blood Glucose Detection in Non-diabetic Subjects

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Multi-channel Microspatial Offset Raman Scattering Spectroscopy (mμSORS) for Noninvasive Blood Glucose Detection

• Registration Number: NCT06512077
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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 mmol/l 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 mmol/l 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 3.0-4.0mmol/l for about 1.5-2.0 hours, blood glucose will be detected every 10 minutes.

Study Timeline

• Study Start: 2024-07-11
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical Validation of mμSORS for Noninvasive Blood Glucose Detection in healthy subjects	Multi-channel Microspatial Offset Raman Scattering Spectroscopy (mμSORS) for Noninvasive Blood Glucose Detection	Enrolled subjects will perform oral glucose tolerance test or hyperinsulin-hypoglucose clamp test. A measurement session of blood glucose consists of plasma sample and a measurement by mμSORS will be conducted synchronously.

Primary Outcome Measures

Name	Time	Method
Mean absolute relative deviation (MARD) of venous plasma glucose and glucose values measured by mμSORS at each time point of OGTT and hypoglucose clamp tests.	2 months	Glucose will be measured using both intravenous sampling (plasma) and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS) detection synchronously.
Consensus Error Grid (CEG) for venous plasma glucose and glucose values measured by mμSORS at each time point of OGTT and hypoglucose clamp tests.	2 months	Glucose will be measured using both intravenous sampling (plasma) and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS) detection synchronously.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events.	2 months	Safety outcomes.
MARD for two measurement methods in different blood glucose ranges.	2 months	Plasma glucose ranges 3.9-10.0 mmol/L and \<3.9 mmol/L.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China