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

Revlis Biotech Company Limited

Status

Completed

Conditions

Diabetes

Glucose

Treatments

Behavioral: dietary control

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT07088497

N202505166

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.