Preclinical Research of mμSORS for Noninvasive Blood Glucose Detection
NCT05921344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-02-05
Summary
This is a single-center, open-label, prospective study. Blood glucose was measured at different time points during oral glucose tolerance testing in patients with type 2 diabetes mellitus, 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 validated. MARD for two measurement methods in different blood glucose ranges and the safety outcomes of mμSORS such as adverse events will also be assessed.
Conditions
- Type 2 Diabetes
- Medical Device
Interventions
- DEVICE
-
Multi-channel Microspatial Offset Raman Scattering Spectroscopy (mμSORS) for Noninvasive Blood Glucose Detection
Blood glucose of participants were measured by venous plasma and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS). The two measurements were collected synchronously and analyzed.
Sponsors & Collaborators
-
Shanghai Photonic View Technology Co., Ltd.
collaborator UNKNOWN -
Shanghai Jiao Tong University School of Medicine
lead OTHER
Principal Investigators
-
Weiqing Wang, Dr. · Ruijin Hospital
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-11
- Primary Completion
- 2023-09-19
- Completion
- 2023-10-10
Countries
- China
Study Locations
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