GlucoseNCT07088497
Cmate Blood Glucose Analyzer: Clinical Comparison Study of Fasting Blood Glucose Levels in the Morning
An observational study of Glucose and Diabetes, run by Revlis Biotech Company Limited at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Jul 2025to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population are patients from Taipei Medical University Shuang Ho Hospital and nearby volunteers.
Who may be able to join
- 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:
- Healthy participants (15 individuals): fasting blood glucose <100 mg/dL, HbA1c <5.7%.
- Pre-diabetic participants (15 individuals): fasting blood glucose ≤100 mg/dL and <126 mg/dL, HbA1c ≤5.7% and <6.5%.
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- dietary control
- Keywords
- Non-invasive
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic subjects | 70 mg/dL< fasting blood glucose <100 mg/dL, HbA1c <5.7% Receives: Behavioral: dietary control | |
| Pre-diabetic subjects | 100 mg/dL≤ fasting blood glucose <126 mg/dL, 5.7% ≤HbA1c<6.5% Receives: Behavioral: dietary control | |
| Type 2 diabetes subjects | 126 mg/dL ≤ fasting blood glucose, 6.5% ≤HbA1c, no insulin injection Receives: Behavioral: dietary control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 60 days after the test day.
Secondary outcomes (2)
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.
Measured: Within 60 days after the test day.
HbA1c accuracy
Comparison of venous plasma HbA1c levels of subjects with non-invasive HbA1c levels.
Measured: Within 60 days after the test day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start21 Jul 2025
- Primary completion30 Sep 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revlis Biotech Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University, Taipei Medical University Shuang Ho Hospital
- Responsible party
- Sponsor
- Investigators
- Ju-Chi Liu, Doctor, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088497
- Sponsor's protocol ID
- N202505166
- Status last verified
- Jan 2026
- First submitted
- 10 Jul 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cmate Blood Glucose Analyzer: Clinical Comparison Study of Fasting Blood Glucose Levels in the Morning
- ClinicalTrials.gov ID
- NCT07088497
- Acronym / sponsor ID
- N202505166
- Keywords
- Non-invasive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Revlis Biotech Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University, Taipei Medical University Shuang Ho Hospital
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic subjects | – | Behavioral: dietary control70 mg/dL< fasting blood glucose <100 mg/dL, HbA1c <5.7% |
| Pre-diabetic subjects | – | Behavioral: dietary control100 mg/dL≤ fasting blood glucose <126 mg/dL, 5.7% ≤HbA1c<6.5% |
| Type 2 diabetes subjects | – | Behavioral: dietary control126 mg/dL ≤ fasting blood glucose, 6.5% ≤HbA1c, no insulin injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are patients from Taipei Medical University Shuang Ho Hospital and nearby volunteers.
Key inclusion criteria (8 listed)
- 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:
- The proportion of males and females in each group is >30%.
- Meets the signal acceptance criteria of the Cmate blood glucose analyzer.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary controlSubjects 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. | Behavioural | Non-diabetic subjects, Pre-diabetic subjects, Type 2 diabetes subjects |
Primary outcome
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.
2 secondary outcomes
Non-invasive glucose levels accuracy
Time frame: Within 60 days after the test day.
HbA1c accuracy
Time frame: Within 60 days after the test day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju-Chi Liu, Doctor principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose and Diabetes, run by Revlis Biotech Company Limited at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive glucose levels accuracy (time frame: Within 60 days after the test day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.