Preclinical Research of mμSORS for Noninvasive Blood Glucose Detection

NCT05921344 | Completed

• 1 other identifier: CCEMD2023001
• Study Type: interventional
• Target: 200
• 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 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

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.

  Four 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.

  Four months.

Secondary Outcomes (2)

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

  Four months.

• Incidence of Treatment-Emergent Adverse Events

  Four months.

Study Arms (1)

Preclinical Research 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.

Preclinical Research of mμSORS for Noninvasive Blood Glucose Detection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects with type 2 diabetes mellitus;
• \. Age ≥ 18 years;
• \. 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:

• \. Type 1 diabetes, monogenic 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(MDRD eGFR\< 60 ml/min/1.73m2); and mental disorders, etc.;
• \. With a history of acute complications of diabetes within 3 months before enrollment; or severe chronic complications of diabetes;
• \. 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 blood-injection-injury phobia;
• \. 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 Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; 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: June 19, 2023
• First Posted: June 27, 2023
• Study Start: July 11, 2023
• Primary Completion: September 19, 2023
• Study Completion: October 10, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

CN (1)