Clinical Evaluation of Non-invasive Blood Glucose Meter

Официальное название

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

Обзор

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.

Подробное описание

After screening, the qualified subjects complete the blood glucose measurement in three ways at the following time points on the test day, namely, fasting blood glucose before breakfast, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.

Вмешательства

• Устройство non-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.
• Устройство fully 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.
• Устройство fingertip 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.

Первичные конечные точки

• Consensus Error Grid (CEG) for venous plasma glucose and glucose values measured by non-invasive glucose meter of mμSORS at each time point indicated. [Срок оценки: 3 months]

Вторичные конечные точки (11)

• The MARD were evaluated for non-invasive glucose meter using venous plasma glucose as the control. [Срок оценки: 3 months]
• The ±20% agreement were evaluated for non-invasive glucose meter using venous plasma glucose as the control. [Срок оценки: 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. [Срок оценки: 3 months]
• The regression analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control. [Срок оценки: 3 months]
• The bland-Altman analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control. [Срок оценки: 3 months]
• The MARD were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. [Срок оценки: 3 months]
• The ±20% agreement were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. [Срок оценки: 3 months]
• The point proportion of A+B region of Clarke error grid analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. [Срок оценки: 3 months]
• The regression analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. [Срок оценки: 3 months]
• The bland-Altman analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. [Срок оценки: 3 months]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: 3 months]

Критерии участия

Критерии включения

Inclusion Criteria for healthy subjects:

• 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.

Inclusion Criteria for patients with type 2 diabetes:

• 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.

Критерии исключения

Exclusion Criteria for healthy subjects:

• 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.

Exclusion Criteria for patients with type 2 diabetes:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Ruijin Hospital — Шанхай

Идентификаторы

NCT: NCT06796322 · JGKJ01202401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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