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NCT Number: NCT07088497

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

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.

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Key information

Conditions

Glucose Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 80.
  • 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.

Treatment and study plan

Dietary Control

Behavioral

Subjects are required to have dinner at a specific time on the night before the test and to remain fasting on the next day until the test.

Primary outcomes

  1. Non-invasive glucose levels accuracy

    Time frame: 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.

Secondary outcomes

  1. Non-invasive glucose levels accuracy

    Time frame: Within 60 days after the test day.

    Comparison of whole blood glucose levels measured at the fingertip of subjects with non-invasive glucose levels measured by the Cmate glucose analyzer.

  2. HbA1c accuracy

    Time frame: Within 60 days after the test day.

    Comparison of venous plasma HbA1c levels of subjects with non-invasive HbA1c levels.

Sponsors and collaborators

Lead sponsor

Revlis Biotech Company Limited

Industry

Collaborators

  • Taipei Medical University
  • Taipei Medical University Shuang Ho Hospital

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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