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

NCT ID: NCT07088497

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-21
• Study Completion Date: 2025-10-30

Brief Summary

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.

Conditions

Glucose; Diabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-diabetic subjects

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

dietary control

Intervention Type: 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.

Pre-diabetic subjects

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

dietary control

Intervention Type: 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.

Type 2 diabetes subjects

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

dietary control

Intervention Type: 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.

Interventions

dietary control

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Individuals willing to sign an informed consent form.

2. Adults aged 18 to 80 years.

3. 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.

4. The proportion of males and females in each group is >30%.

5. Meets the signal acceptance criteria of the Cmate blood glucose analyzer.

Exclusion Criteria

1. Individuals who refuse to sign the informed consent form.

2. Adults who lack legal capacity.

3. Individuals under the age of 18 or over the age of 80.

4. Individuals with a history of major cardiac conditions such as stroke, myocardial infarction, heart failure, coronary artery bypass surgery, stent placement, or pacemaker implantation.

5. 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.

6. Type 1 diabetes patients.

7. Individuals with a history of gestational diabetes.

8. Pregnant women.

9. Individuals with fasting blood glucose levels below 70 mg/dL or above 200 mg/dL within the past three months.

10. Individuals whose signal characteristics do not meet the acceptance criteria of the Cmate blood glucose analyzer.

11. Individuals deemed ineligible for inclusion by the study principal investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: collaborator

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: collaborator

Revlis Biotech Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ju-Chi Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Locations

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Countries

Taiwan

Other Identifiers

N202505166

Identifier Type: -

Identifier Source: org_study_id