Diabetes MellitusNCT06796322
Clinical Evaluation of Non-invasive Blood Glucose Meter
A study testing non-invasive blood glucose meter, fully automatic laboratory biochemical analyzer and fingertip capillary blood glucose meter in people with Diabetes Mellitus, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This trial is a prospective, multicenter, non-randomized, open-label, self-controlled, paired design clinical study, which will be conducted in 3 research centers, with a total of 210 subjects enrolled, including diabetic patients aged 18 years and above and some healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- non-invasive blood glucose meter, fully automatic laboratory biochemical analyzer and fingertip capillary blood glucose meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, aged >=18 years.
- Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form.
- Male or female, aged >=18 years.
- Previously diagnosed type 2 diabetes according to WHO criteria of 1999.
- Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form.
Who cannot join
- There are injuries, scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested.
- Allergy to lasers.
- Had diabetes history or fasting blood glucose (FPG) >= 6.1 mmol/L or glycated hemoglobin (HbA1c) >= 5.7% during the screening period.
- Alcohol dependency or drug abuse.
- Those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial).
- Pregnancy or lactation period.
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- Difficulty in venous blood collection or fainting of needles or blood.
- Other circumstances that the investigator considers inappropriate to participate in the study.
- There are injuries, scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested.
- Allergy to lasers.
- Type 1 diabetes, monogenic mutant diabetes, pancreatic damage, or secondary diabetes of other causes should be excluded.
- Severe structural heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, chronic congestive heart failure (NYHA≥III); acute myocardial infarction within 12 months before enrollment; history of severe liver or kidney dysfunction (eGFR < 60 ml/min/1.73m2 calculated by MDRD formula at screening period); and mental disorders, etc.
- With a history of acute complications of diabetes within 3 months before enrollment; or severe diabetes-related complications.
- Alcohol dependency or drug abuse.
- Those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial).
- Pregnancy or lactation period.
- Difficulty in venous blood collection or fainting of needles or blood.
- Other circumstances that the investigator considers inappropriate to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Long Wang, Dr., +86021-64370045 ext. 681701, wanglong2995@163.com
About this study
Official title: A Prospective, Multicenter, Non-randomized, Open-label, Self-controlled, Paired Clinical Trial to Evaluate the Effectiveness and Safety of a Non-invasive Blood Glucose Meter Compared With Laboratory Detection in Diabetic Patients
This trial is a prospective, multicenter, non-randomized, open-label, self-controlled, paired design clinical study, which will be conducted in 3 research centers, with a total of 210 subjects enrolled, including diabetic patients aged 18 years and above and some healthy subjects. After screening, each eligible subject will have their blood glucose measured simultaneously at specified time points using three methods: non-invasive blood glucose meter (the experimental group), fully automatic laboratory biochemical analyzer (the primary control group) using the hexokinase method to measure venous plasma blood glucose, and fingertip capillary blood sample (the secondary control group) to detect fingertip capillary blood glucose. The aim of this trial is to evaluate the efficacy and safety of the non-invasive blood glucose meter for blood glucose measurement in diabetic patients.
Read the detailed description
After screening, the qualified subjects complete the blood glucose measurement in three ways at the following time points on the test day, namely, fasting blood glucose before breakfast, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.
- Conditions
- Diabetes Mellitus
- Being tested
- non-invasive blood glucose meter, fully automatic laboratory biochemical analyzer, fingertip capillary blood glucose meter
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive blood glucose meterDevice
Blood glucose were detected by non-invasive glucose meter at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.
fully automatic laboratory biochemical analyzerDevice
Blood glucose were detected by fully automatic laboratory biochemical analyzer using plasma sample at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.
fingertip capillary blood glucose meterDevice
Blood glucose were detected by fingertip capillary blood sample at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive blood glucose meter | Experimental | Non-invasive blood glucose meter by the non-invasive blood glucose meter using a Raman spectrum measurement system. Receives: Device: non-invasive blood glucose meter |
| Fully automatic laboratory biochemical analyzer | Other | Fully automatic laboratory biochemical analyzer (the primary control group) using the hexokinase method to measure venous plasma blood glucose. Receives: Device: fully automatic laboratory biochemical analyzer |
| Fingertip capillary blood sample | Other | Fingertip capillary blood sample (the secondary control group) to detect fingertip capillary blood glucose. Receives: Device: fingertip capillary blood glucose meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus Error Grid (CEG) for venous plasma glucose and glucose values measured by non-invasive glucose meter of mμSORS at each time point indicated.
Glucose will be measured using both intravenous sampling (plasma) and non-invasive meter of mμSORS synchronously.
Measured: 3 months
Secondary outcomes (11)
The MARD were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
The interval between the two methods is less than 10 minutes at each point.
Measured: 3 months
The ±20% agreement were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
The interval between the two methods is less than 10 minutes at each point.
Measured: 3 months
The point proportion of A+B region of Clarke error grid analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
The interval between the two methods is less than 10 minutes at each point.
Measured: 3 months
The regression analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
The interval between the two methods is less than 10 minutes at each point.
Measured: 3 months
The bland-Altman analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
The interval between the two methods is less than 10 minutes at each point.
Measured: 3 months
The MARD were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
The interval between the two methods is less than 10 minutes at each point.
Measured: 3 months
The ±20% agreement were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
The interval between the two methods is less than 10 minutes at each point.
Measured: 3 months
The point proportion of A+B region of Clarke error grid analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
The interval between the two methods is less than 10 minutes at each point.
Measured: 3 months
The regression analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
The interval between the two methods is less than 10 minutes at each point.
Measured: 3 months
The bland-Altman analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
The interval between the two methods is less than 10 minutes at each point.
Measured: 3 months
Incidence of Treatment-Emergent Adverse Events
Safety in the patients.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Jan 2025
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Glucose detection
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Hanchuan People's Hospital
- Responsible party
- Principal investigator, Wang Weiqing, Shanghai Jiao Tong University School of Medicine
- Investigators
- Weiqing Wang, Dr., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796322
- Sponsor's protocol ID
- JGKJ01202401
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-randomized, Open-label, Self-controlled, Paired Clinical Trial to Evaluate the Effectiveness and Safety of a Non-invasive Blood Glucose Meter Compared With Laboratory Detection in Diabetic Patients
- ClinicalTrials.gov ID
- NCT06796322
- Acronym / sponsor ID
- JGKJ01202401
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Hanchuan People's Hospital
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 28 Jan 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.
This trial is a prospective, multicenter, non-randomized, open-label, self-controlled, paired design clinical study, which will be conducted in 3 research centers, with a total of 210 subjects enrolled, including diabetic patients aged 18 years and above and some healthy subjects. After screening, each eligible subject will have their blood glucose measured simultaneously at specified time points using three methods: non-invasive blood glucose meter (the experimental group), fully automatic laboratory biochemical analyzer (the primary control group) using the hexokinase method to measure venous plasma blood glucose, and fingertip capillary blood sample (the secondary control group) to detect fingertip capillary blood glucose. The aim of this trial is to evaluate the efficacy and safety of the non-invasive blood glucose meter for blood glucose measurement in diabetic patients.
Detailed description
After screening, the qualified subjects complete the blood glucose measurement in three ways at the following time points on the test day, namely, fasting blood glucose before breakfast, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Glucose detection
| Arm | Type | Receives |
|---|---|---|
| Non-invasive blood glucose meter | Experimental | Device: non-invasive blood glucose meterNon-invasive blood glucose meter by the non-invasive blood glucose meter using a Raman spectrum measurement system. |
| Fully automatic laboratory biochemical analyzer | Other | Device: fully automatic laboratory biochemical analyzerFully automatic laboratory biochemical analyzer (the primary control group) using the hexokinase method to measure venous plasma blood glucose. |
| Fingertip capillary blood sample | Other | Device: fingertip capillary blood glucose meterFingertip capillary blood sample (the secondary control group) to detect fingertip capillary blood glucose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged >=18 years.
- Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form.
- Male or female, aged >=18 years.
- Previously diagnosed type 2 diabetes according to WHO criteria of 1999.
- Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form.
Key exclusion criteria (18 listed)
- There are injuries, scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested.
- Allergy to lasers.
- Had diabetes history or fasting blood glucose (FPG) >= 6.1 mmol/L or glycated hemoglobin (HbA1c) >= 5.7% during the screening period.
- Alcohol dependency or drug abuse.
- Those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial).
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 |
|---|---|---|
| non-invasive blood glucose meterBlood glucose were detected by non-invasive glucose meter at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast. | Device | Non-invasive blood glucose meter |
| fully automatic laboratory biochemical analyzerBlood glucose were detected by fully automatic laboratory biochemical analyzer using plasma sample at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast. | Device | Fully automatic laboratory biochemical analyzer |
| fingertip capillary blood glucose meterBlood glucose were detected by fingertip capillary blood sample at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast. | Device | Fingertip capillary blood sample |
Primary outcome
Consensus Error Grid (CEG) for venous plasma glucose and glucose values measured by non-invasive glucose meter of mμSORS at each time point indicated.
Time frame: 3 months
Glucose will be measured using both intravenous sampling (plasma) and non-invasive meter of mμSORS synchronously.
11 secondary outcomes
The MARD were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
Time frame: 3 months
The ±20% agreement were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
Time frame: 3 months
The point proportion of A+B region of Clarke error grid analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
Time frame: 3 months
The regression analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
Time frame: 3 months
The bland-Altman analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
Time frame: 3 months
The MARD were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
Time frame: 3 months
The ±20% agreement were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
Time frame: 3 months
The point proportion of A+B region of Clarke error grid analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
Time frame: 3 months
The regression analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
Time frame: 3 months
The bland-Altman analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
Time frame: 3 months
Incidence of Treatment-Emergent Adverse Events
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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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.
Weiqing Wang, Dr. principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive blood glucose meter, fully automatic laboratory biochemical analyzer and fingertip capillary blood glucose meter in people with Diabetes Mellitus, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 5 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifei Zhang, Dr. (13524640378, feifei-a@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus Error Grid (CEG) for venous plasma glucose and glucose values measured by non-invasive glucose meter of mμSORS at each time point indicated. (time frame: 3 months). 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 28 Jan 2025.