Clinical Evaluation of Non-invasive Blood Glucose Meter

NCT06796322 | Recruiting

• 1 other identifier: JGKJ01202401
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a prospective, multicenter, non-randomized, open-label, self-controlled, paired design clinical study, which will be conducted in 3 research centers, with a total of 210 subjects enrolled, including diabetic patients aged 18 years and above and some healthy subjects. After screening, each eligible subject will have their blood glucose measured simultaneously at specified time points using three methods: non-invasive blood glucose meter (the experimental group), fully automatic laboratory biochemical analyzer (the primary control group) using the hexokinase method to measure venous plasma blood glucose, and fingertip capillary blood sample (the secondary control group) to detect fingertip capillary blood glucose. The aim of this trial is to evaluate the efficacy and safety of the non-invasive blood glucose meter for blood glucose measurement in diabetic patients.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Consensus Error Grid (CEG) for venous plasma glucose and glucose values measured by non-invasive glucose meter of mμSORS at each time point indicated.

  Glucose will be measured using both intravenous sampling (plasma) and non-invasive meter of mμSORS synchronously.

  3 months

Secondary Outcomes (11)

• The MARD were evaluated for non-invasive glucose meter using venous plasma glucose as the control.

  3 months

• The ±20% agreement were evaluated for non-invasive glucose meter using venous plasma glucose as the control.

  3 months

• The point proportion of A+B region of Clarke error grid analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control.

  3 months

• The regression analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control.

  3 months

• The bland-Altman analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control.

  3 months

Study Arms (3)

Non-invasive blood glucose meter

EXPERIMENTAL

Non-invasive blood glucose meter by the non-invasive blood glucose meter using a Raman spectrum measurement system.

Device: non-invasive blood glucose meter

Fully automatic laboratory biochemical analyzer

OTHER

Fully automatic laboratory biochemical analyzer (the primary control group) using the hexokinase method to measure venous plasma blood glucose.

Device: fully automatic laboratory biochemical analyzer

Fingertip capillary blood sample

OTHER

Fingertip capillary blood sample (the secondary control group) to detect fingertip capillary blood glucose.

Device: fingertip capillary blood glucose meter

Interventions

non-invasive blood glucose meter DEVICE

Blood glucose were detected by non-invasive glucose meter at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.

Non-invasive blood glucose meter

fully automatic laboratory biochemical analyzer DEVICE

Blood glucose were detected by fully automatic laboratory biochemical analyzer using plasma sample at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.

Fully automatic laboratory biochemical analyzer

fingertip capillary blood glucose meter DEVICE

Blood glucose were detected by fingertip capillary blood sample at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.

Fingertip capillary blood sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged \>=18 years.
• 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, aged \>=18 years.
• Previously diagnosed type 2 diabetes according to WHO criteria of 1999.
• 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:

• There are injuries, scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested.
• Allergy to lasers.
• Had diabetes history or fasting blood glucose (FPG) \>= 6.1 mmol/L or glycated hemoglobin (HbA1c) \>= 5.7% during the screening period.
• 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.
• There are injuries, scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested.
• Allergy to lasers.
• 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).

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Shanghai 10th People's Hospital: collaborator
• Hanchuan People's Hospital: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

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

Central Study Contacts

Yifei Zhang, Dr.

CONTACT

13524640378; feifei-a@163.com

Study Design

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

Model Details: Glucose detection

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 28, 2025
• Study Start: January 1, 2025
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

CN (1)