RecruitingNot ApplicableNCT06796322

Clinical Evaluation of Non-invasive Blood Glucose Meter

A Prospective, Multicenter, Non-randomized, Open-label, Self-controlled, Paired Clinical Trial to Evaluate the Effectiveness and Safety of a Non-invasive Blood Glucose Meter Compared With Laboratory Detection in Diabetic Patients

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

210 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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.

Exclusion Criteria18

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).
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.

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Interventions

DEVICEnon-invasive blood glucose meter

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.

DEVICEfully automatic laboratory biochemical analyzer

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.

DEVICEfingertip capillary blood glucose meter

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.