Clinical Validation of mμSORS for Noninvasive Blood Glucose Detection

Status Not yet recruiting

Clinical Trial Summary

This is a single-center, open-label, prospective study. Blood glucose was measured at different time points during oral glucose tolerance testing in healthy subjects and 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 effect of mμSORS on safety in the patient such as adverse events will also be assessed.

Clinical Trial Description

In order to clinically verify the accuracy and safety of non-invasive blood glucose measurement by the mμSORS technology, and to construct a model, this study will conduct oral glucose tolerance tests on healthy subjects and patients with type 2 diabetes at different time points during the OGTT. There will be 12 points as follows: 0-min and post glucose-load 10-min，30-min，60-min，90-min，120-min，150-min，180-min，210-min，240-min，270-min， and 300-min. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05504005
Study type	Interventional
Source	Shanghai Jiao Tong University School of Medicine
Contact
Status	Not yet recruiting
Phase	N/A
Start date	August 19, 2022
Completion date	December 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03743779` - Mastering Diabetes Pilot Study
Completed	`NCT03786978` - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus	N/A
Completed	`NCT01804803` - DIgital Assisted MONitoring for DiabeteS - I	N/A
Completed	`NCT05039970` - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT04068272` - Safety of Bosentan in Type II Diabetic Patients	Phase 1
Completed	`NCT03243383` - Readmission Prevention Pilot Trial in Diabetes Patients	N/A
Completed	`NCT03730480` - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)	N/A
Recruiting	`NCT02690467` - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.	N/A
Completed	`NCT02229383` - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus	Phase 3
Completed	`NCT06181721` - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes	N/A
Completed	`NCT05799976` - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure	N/A
Recruiting	`NCT04489043` - Exercise, Prediabetes and Diabetes After Renal Transplantation.	N/A
Withdrawn	`NCT03319784` - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients	Phase 4
Completed	`NCT03542084` - Endocrinology Auto-Triggered e-Consults	N/A
Completed	`NCT02229396` - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo	Phase 3
Recruiting	`NCT05544266` - Rare and Atypical Diabetes Network
Completed	`NCT01892319` - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed	`NCT05031000` - Blood Glucose Monitoring Systems: Discounter Versus Brand	N/A
Recruiting	`NCT04039763` - RT-CGM in Young Adults at Risk of DKA	N/A