Clinical Validation of mμSORS for Noninvasive Blood Glucose Detection

NCT05504005 | Completed

• 1 other identifier: CCEMD2022002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Medical Device

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• MARD for two measurement methods in different blood glucose ranges.

  2 months

• Incidence of Treatment-Emergent Adverse Events

  2 months

Study Arms (1)

Clinical Validation of mμSORS for Noninvasive Blood Glucose Detection

EXPERIMENTAL

Enrolled subjects will perform oral glucose tolerance test. A measurement session of blood glucose consists of plasma sample and a measurement by mμSORS will be conducted synchronously.

Device: Multi-channel Microspatial Offset Raman Scattering Spectroscopy (mμSORS) for Noninvasive Blood Glucose Detection

Interventions

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

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.

Clinical Validation of mμSORS for Noninvasive Blood Glucose Detection

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Photonic View Technology Co., Ltd.: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Weiqing Wang, Dr.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: October 8, 2022
• Primary Completion: December 31, 2022
• Study Completion: March 1, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (1)