Clinical Validation of mμSORS for Noninvasive Blood Glucose Detection

Diabetes Mellitus Clinical Trial

Official title:

Clinical Validation 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: NCT05504005
• Other study ID #: CCEMD2022002
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 19, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria for healthy subjects:

• Male or female.

• Aged between 30 and 60 years.

• Fasting blood glucose (FPG) < 6.1 mmol/L and glycated hemoglobin (HbA1c) < 5.7% during the screening period.

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

• Confirmed as healthy based on the results of physical examination, medical history, vital signs and clinical laboratory tests.

• 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.

Inclusion Criteria for patients with type 2 diabetes:

• Male or female,previously diagnosed type 2 diabetes.

• Aged between 30 and 60 years.

• Fasting plasma glucose = 6.1 and < 13.3 mmol/L.

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

• 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 for healthy subjects:

• Any history of serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry or metabolic abnormality, or any other disease that can interfere with the test results, which the investigator considers significant.

• Alcohol dependency or drug abuse.

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

• Pregnancy or lactation period.

• Difficulty in venous blood collection or fainting of needles or blood.

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

Exclusion Criteria for patients with type 2 diabetes:

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

• 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 (eGFR < 60 ml/min/1.73m2 calculated by MDRD formula at screening period); and mental disorders, etc.

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

• Alcohol dependency or drug abuse.

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

• Pregnancy or lactation period.

• Difficulty in venous blood collection or fainting of needles or blood.

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Medical Device

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
n/a

Sponsors (2)

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

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.	2 months
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.	2 months
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.	2 months
Secondary	Incidence of Treatment-Emergent Adverse Events	Safety in the patients.	2 months