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

NCT07088497 | Completed

• 1 other identifier: N202505166
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Non-invasive

Outcome Measures

Primary Outcomes (1)

• Non-invasive glucose levels accuracy

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

  Within 60 days after the test day.

Secondary Outcomes (2)

• Non-invasive glucose levels accuracy

  Within 60 days after the test day.

• HbA1c accuracy

  Within 60 days after the test day.

Study Arms (3)

Non-diabetic subjects

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

Behavioral: dietary control

Pre-diabetic subjects

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

Behavioral: dietary control

Type 2 diabetes subjects

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

Behavioral: dietary control

Interventions

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.

Non-diabetic subjects; Pre-diabetic subjects; Type 2 diabetes subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population are patients from Taipei Medical University Shuang Ho Hospital and nearby volunteers.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: collaborator
• Revlis Biotech Company Limited: lead
• Taipei Medical University Shuang Ho Hospital: collaborator

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ju-Chi Liu, Doctor

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 28, 2025
• Study Start: July 21, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 1 month after publication of results and ending at December 2026

Locations

TW (1)