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临床试验/NCT07088497
NCT07088497已完成不适用

Cmate Blood Glucose Analyzer: Clinical Comparison Study of Fasting Blood Glucose Levels in the Morning

Revlis Biotech Company Limited1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Non-invasive glucose levels accuracy

研究概览

简要总结

As of February 2024, there are 529 million people worldwide living with diabetes. The number of diabetes patients continues to rise annually, and there is also a trend toward younger patients. Blood glucose management is crucial for prediabetes and diabetes patients. Effectively controlling blood glucose levels can reduce the risk of complications such as vascular complications, retinopathy, cardiovascular disease, and kidney disease. Traditionally, blood glucose monitoring in home settings has primarily relied on fingerstick whole blood samples combined with a blood glucose meter. However, this method poses risks associated with the disposal of used lancets and test strips, and the discomfort caused by the blood draw process can also lead to psychological stress for users. To enhance users' willingness to monitor blood glucose regularly and reduce environmental pollution from waste, the non-invasive blood glucose measurement system applied in this study is a non-invasive monitoring technology that is not a medical device and has not yet been marketed. It is currently undergoing the application process for FDA medical device certification in the United States. This trial will collect fasting venous plasma glucose levels, HbA1c, fingerstick whole blood glucose levels, and non-invasive glucose levels from patients in the morning. The primary analysis indicator is the correlation analysis between venous plasma glucose levels and non-invasive glucose levels.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals willing to sign an informed consent form.
  • Adults aged 18 to 80 years.
  • Individuals with a past medical history diagnosed by a physician as meeting the following criteria, totaling 45 participants:
  • A. Healthy participants (15 individuals): fasting blood glucose <100 mg/dL, HbA1c <5.7%.
  • B. Pre-diabetic participants (15 individuals): fasting blood glucose ≤100 mg/dL and <126 mg/dL, HbA1c ≤5.7% and <6.5%.
  • C. Patients with type 2 diabetes (15 individuals): fasting blood glucose ≥126 mg/dL, HbA1c ≥6.5%, and no insulin injection.
  • The proportion of males and females in each group is >30%.
  • Meets the signal acceptance criteria of the Cmate blood glucose analyzer.

排除标准

  • Individuals who refuse to sign the informed consent form.
  • Adults who lack legal capacity.
  • Individuals under the age of 18 or over the age of
  • Individuals with a history of major cardiac conditions such as stroke, myocardial infarction, heart failure, coronary artery bypass surgery, stent placement, or pacemaker implantation.
  • Individuals with controlled heart disease who, during the screening visit, were found to have signal characteristics that cannot be used when screened with the Cmate blood glucose analyzer.
  • Type 1 diabetes patients.
  • Individuals with a history of gestational diabetes.
  • Pregnant women.
  • Individuals with fasting blood glucose levels below 70 mg/dL or above 200 mg/dL within the past three months.
  • Individuals whose signal characteristics do not meet the acceptance criteria of the Cmate blood glucose analyzer.
  • Individuals deemed ineligible for inclusion by the study principal investigator.

研究组 & 干预措施

Non-diabetic subjects

70 mg/dL< fasting blood glucose <100 mg/dL, HbA1c <5.7%

干预措施: dietary control (Behavioral)

Pre-diabetic subjects

100 mg/dL≤ fasting blood glucose <126 mg/dL, 5.7% ≤HbA1c<6.5%

干预措施: dietary control (Behavioral)

Type 2 diabetes subjects

126 mg/dL ≤ fasting blood glucose, 6.5% ≤HbA1c, no insulin injection

干预措施: dietary control (Behavioral)

结局指标

主要结局

Non-invasive glucose levels accuracy

时间窗: Within 60 days after the test day.

Comparison of venous plasma glucose levels in test subjects with non-invasive glucose levels measured by the Cmate glucose analyzer.

次要结局

  • Non-invasive glucose levels accuracy(Within 60 days after the test day.)
  • HbA1c accuracy(Within 60 days after the test day.)

研究者

发起方
Revlis Biotech Company Limited
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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