Preclinical Research of mμSORS for Noninvasive Blood Glucose Detection

Type 2 Diabetes Clinical Trial

Official title:

Preclinical Research of Multi-channel Microspatial Offset Raman Scattering Spectroscopy (mμSORS) for Noninvasive Blood Glucose Detection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05921344
• Other study ID #: CCEMD2023001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: June 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Bei Tao, Dr.
• Phone: +86-13916558450
• Email: taobei1981[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

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 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.

Description:

In order to clinically verify the accuracy and safety of non-invasive blood glucose measurement by the mμSORS technology, and to explore the feasibility of non-invasive detection in multi-indicators of mμSORS, this study will conduct an oral glucose tolerance test on patients with type 2 diabetes. There will be 12 collection points of blood samples as follows: 0-min and post glucose-load 15-min，30-min，45-min，60-min，75-min，90-min，105-min，120-min，135-min，150-min， and 180-min. Approximately 4ml of whole blood was collected at each time point for venous plasma glucose and serum insulin measurement. The blood glucose value measured by mμSORS will be obtained synchronously at the above 12 time points.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Subjects with type 2 diabetes mellitus;

• 2. Age = 18 years;

• 3. There are no scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested;

• 4. Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form.

Exclusion Criteria:

• 1. Type 1 diabetes, monogenic diabetes, pancreatic damage, or secondary diabetes of other causes should be excluded;

• 2. Severe structural heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, chronic congestive heart failure (NYHA=III); acute myocardial infarction within 12 months before enrollment; history of severe liver or kidney dysfunction(MDRD eGFR< 60 ml/min/1.73m2); and mental disorders, etc.;

• 3. With a history of acute complications of diabetes within 3 months before enrollment; or severe chronic complications of diabetes;

• 4. Alcohol dependency or drug abuse;

• 5. Those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial);

• 6. Pregnancy or lactation period;

• 7. Difficulty in venous blood collection or blood-injection-injury phobia;

• 8. Other circumstances that the investigator considers inappropriate to participate in the study.

Related Conditions & MeSH terms

• Medical Device
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Shanghai Photonic View Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean absolute relative deviation (MARD) of venous plasma glucose and glucose values measured by mµSORS at each time point of OGTT.	Glucose will be measured using both intravenous sampling (plasma) and multi-channel microspatial offset Raman scattering spectroscopy (mµSORS) detection synchronously.	120minutes per subject.
Primary	Consensus Error Grid (CEG) for venous plasma glucose and glucose values measured by mµSORS at each time point of OGTT.	Glucose will be measured using both intravenous sampling (plasma) and multi-channel microspatial offset Raman scattering spectroscopy (mµSORS) detection synchronously.	120minutes per subject.
Secondary	MARD for two measurement methods in different blood glucose ranges.	Plasma glucose ranges 3.9-10.0 mmol/L, <3.9 mmol/L and >10.0 mmol/L.	120minutes per subject.
Secondary	Incidence of Treatment-Emergent Adverse Events	Safety outcomes.	120minutes per subject.