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| Name | Class |
|---|---|
| Taipei Medical University | OTHER |
| Taipei Medical University Shuang Ho Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-diabetic subjects | 70 mg/dL< fasting blood glucose <100 mg/dL, HbA1c <5.7% |
| |
| Pre-diabetic subjects | 100 mg/dL≤ fasting blood glucose <126 mg/dL, 5.7% ≤HbA1c<6.5% |
| |
| Type 2 diabetes subjects | 126 mg/dL ≤ fasting blood glucose, 6.5% ≤HbA1c, no insulin injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-invasive glucose levels accuracy | Comparison of whole blood glucose levels measured at the fingertip of subjects with non-invasive glucose levels measured by the Cmate glucose analyzer. | Within 60 days after the test day. |
| HbA1c accuracy |
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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:
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The study population are patients from Taipei Medical University Shuang Ho Hospital and nearby volunteers.
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| Name | Affiliation | Role |
|---|---|---|
| Ju-Chi Liu, Doctor | Taipei Medical University Shuang Ho Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Shuang Ho Hospital | New Taipei City | Taiwan |
All IPD that underlie results in a publication.
Beginning 1 month after publication of results and ending at December 2026
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Comparison of venous plasma HbA1c levels of subjects with non-invasive HbA1c levels.
| Within 60 days after the test day. |