Diabetes MellitusNCT06017349
To Evaluate the Efficacy and Safety of Multi-parameter Non-Invasive Glucose Sensors for for Blood Glucose Measurement
A study testing Non-invasive glucose meter, EKF analyzer and Accu-Chek Guide in people with Diabetes Mellitus, run by Lepu Medical Technology (Beijing) Co., Ltd. at 1 site in China.
Trial summary
This was a prospective, multicenter, open-label, self-controlled study to evaluate the efficacy and safety of multi-parameter non-invasive glucose meters for blood glucose measurement，planned enrollment of 200 patients with type 1 or type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Non-invasive glucose meter, EKF analyzer and Accu-Chek Guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2022to 18 Jul 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with diabetes (type 1 or type 2 );
- Participants who could understand the purpose of the trial and signed the informed consent form.
Who cannot join
- Conditions that prevent good contact between the measuring finger and the sensor, resulting in unmeasured conditions, such as hand disability, scar, swelling of the finger, etc.
- Diseases that affect the accuracy of hand measurement, such as Parkinson's disease, upper limb chronic arterial occlusive disease, Raynaud's syndrome, hand or arm trauma surgery, upper limb arteriovenous fistula, etc.
- Fever (axillary temperature >37.3℃) and severe dehydration during screening;
- Diabetic ketoacidosis, hyperglycemic hyperosmolar status within 6 months before signing the informed consent;
- Those who were in serious illness within 1 month before signing the informed consent, such as shock, heart failure, respiratory failure, severe liver and kidney dysfunction, etc.
- Those suffering from mental illness, lack of self-control or unable to express their personal willingness clearly;
- Participants who participated in other drug or device clinical trials within 2 weeks before signing the informed consent (except those who failed in screening);
- Other persons deemed by the investigator to be ineligible for clinical trial participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Open-label, Self-controlled Clinical Trial Protocol to Evaluate the Efficacy and Safety of a Multi-parameter Non-Invasive Glucose Sensors for Measuring Blood Glucose.
This was a prospective, multicenter, open-label, self-controlled study to evaluate the efficacy and safety of multi-parameter non-invasive glucose meters for blood glucose measurement，planned enrollment of 200 patients with type 1 or type 2 diabetes.
Comparing glucose measurements from the Non-Invasive Glucose monitoring system to venous blood glucose or fingertip blood glucose to evaluate System accuracy capability.
Read the detailed description
At the same time, blood glucose was measured by non-invasive blood glucose meter, Accu-Chek Guide blood glucose meter and EKF Biosen C-Line. Eight groups of blood glucose values were collected from each subject during fasting, after breakfast and after lunch.After the end of blood glucose measurement, the data were recorded, including adverse events and device defects during the test. The subjects were required to stay in the examination room for 5-10 minutes, during which they completed the product use evaluation questionnaire.
- Conditions
- Diabetes Mellitus
- Being tested
- Non-invasive glucose meter, EKF analyzer, Accu-Chek Guide
- Keywords
- Blood Glucose Self-Monitoring, Non-invasive 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 glucose meterDevice
Blood glucose levels were measured while fasting, after breakfast, and after lunch，Place your index finger into the non-invasive blood glucose meter and wait for the instrument to display the reading.
EKF analyzerDevice
Blood glucose levels were measured while fasting, after breakfast, and after lunch，After collecting venous blood and separating plasma, blood glucose detection is performed using the EKF analyzer with the hexokinase method.
Accu-Chek GuideDevice
Blood glucose levels were measured while fasting, after breakfast, and after lunch，Use Accu-Chek Guide blood glucose meter to prick the finger and obtain blood for glucose measurement
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive glucose meter | Experimental | The noninvasive glucose meter was entrained on the finger, Glucose concentration levels were measured by measuring physiological parameters related to metabolic heat and local oxygen supply. Receives: Device: Non-invasive glucose meter |
| Accu-Chek Guide blood glucose meter | Active comparator | Being used for quantitative determination of blood glucose concentration in fresh capillary whole blood taken from fingers. Receives: Device: Accu-Chek Guide |
| EKF Biosen C-Line | Active comparator | Using the hexosyl enzymatic method to detect plasma glucose values Receives: Device: EKF analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The results were analyzed by consensus error grid (CEG)
The proportion of the results lie within zone A and zone B of the consensus error grid (CEG)
Measured: After 2 days of blood glucose measurements
Secondary outcomes (3)
Mean Absolute Relative Difference (MARD)
It is calculated by taking the absolute difference between the two values, dividing it by their average. A smaller MARD value indicates a smaller relative difference between the two values, indicating higher consistency between them.
Measured: The day after the blood glucose measurement
The 20/20% agreement rates
the proportion of Non-invasive blood glucose values that were within 20% of paired reference blood glucose values >80 or 20 mg/dL of reference blood glucose values ≤100 mg/dL
Measured: The day after the blood glucose measurement
Accessibility evaluation Questionnaire for non-invasive glucose meter
The questionnaire covers the subjects' self-monitoring of blood glucose status, their awareness and expectations of non-invasive testing, as well as their subjective feelings after using a non-invasive blood glucose meter.
Measured: The day after the blood glucose measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start21 Sep 2022
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linong Ji, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017349
- Sponsor's protocol ID
- LP-NG -2022-1
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-label, Self-controlled Clinical Trial Protocol to Evaluate the Efficacy and Safety of a Multi-parameter Non-Invasive Glucose Sensors for Measuring Blood Glucose.
- ClinicalTrials.gov ID
- NCT06017349
- Acronym / sponsor ID
- LP-NG -2022-1
- Conditions
- Diabetes Mellitus
- Keywords
- Blood Glucose Self-Monitoring, Non-invasive glucose meter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 30 Aug 2023 (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 was a prospective, multicenter, open-label, self-controlled study to evaluate the efficacy and safety of multi-parameter non-invasive glucose meters for blood glucose measurement，planned enrollment of 200 patients with type 1 or type 2 diabetes.
Comparing glucose measurements from the Non-Invasive Glucose monitoring system to venous blood glucose or fingertip blood glucose to evaluate System accuracy capability.
Detailed description
At the same time, blood glucose was measured by non-invasive blood glucose meter, Accu-Chek Guide blood glucose meter and EKF Biosen C-Line. Eight groups of blood glucose values were collected from each subject during fasting, after breakfast and after lunch.After the end of blood glucose measurement, the data were recorded, including adverse events and device defects during the test. The subjects were required to stay in the examination room for 5-10 minutes, during which they completed the product use evaluation questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-invasive glucose meter | Experimental | Device: Non-invasive glucose meterThe noninvasive glucose meter was entrained on the finger, Glucose concentration levels were measured by measuring physiological parameters related to metabolic heat and local oxygen supply. |
| Accu-Chek Guide blood glucose meter | Active comparator | Device: Accu-Chek GuideBeing used for quantitative determination of blood glucose concentration in fresh capillary whole blood taken from fingers. |
| EKF Biosen C-Line | Active comparator | Device: EKF analyzerUsing the hexosyl enzymatic method to detect plasma glucose values |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with diabetes (type 1 or type 2 );
- Participants who could understand the purpose of the trial and signed the informed consent form.
Key exclusion criteria (8 listed)
- Conditions that prevent good contact between the measuring finger and the sensor, resulting in unmeasured conditions, such as hand disability, scar, swelling of the finger, etc.
- Diseases that affect the accuracy of hand measurement, such as Parkinson's disease, upper limb chronic arterial occlusive disease, Raynaud's syndrome, hand or arm trauma surgery, upper limb arteriovenous fistula, etc.
- Fever (axillary temperature >37.3℃) and severe dehydration during screening;
- Diabetic ketoacidosis, hyperglycemic hyperosmolar status within 6 months before signing the informed consent;
- Those who were in serious illness within 1 month before signing the informed consent, such as shock, heart failure, respiratory failure, severe liver and kidney dysfunction, etc.
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 glucose meterBlood glucose levels were measured while fasting, after breakfast, and after lunch，Place your index finger into the non-invasive blood glucose meter and wait for the instrument to display the reading. | Device | Non-invasive glucose meter |
| EKF analyzerBlood glucose levels were measured while fasting, after breakfast, and after lunch，After collecting venous blood and separating plasma, blood glucose detection is performed using the EKF analyzer with the hexokinase method. | Device | EKF Biosen C-Line |
| Accu-Chek GuideBlood glucose levels were measured while fasting, after breakfast, and after lunch，Use Accu-Chek Guide blood glucose meter to prick the finger and obtain blood for glucose measurement | Device | Accu-Chek Guide blood glucose meter |
Primary outcome
The results were analyzed by consensus error grid (CEG)
Time frame: After 2 days of blood glucose measurements
The proportion of the results lie within zone A and zone B of the consensus error grid (CEG)
3 secondary outcomes
Mean Absolute Relative Difference (MARD)
Time frame: The day after the blood glucose measurement
The 20/20% agreement rates
Time frame: The day after the blood glucose measurement
Accessibility evaluation Questionnaire for non-invasive glucose meter
Time frame: The day after the blood glucose measurement
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 30 Aug 2023.
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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.
Linong Ji principal investigator
Peking University People's 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 glucose meter, EKF analyzer and Accu-Chek Guide in people with Diabetes Mellitus, run by Lepu Medical Technology (Beijing) Co., Ltd. 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 2 inclusion and 8 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 30 Aug 2023. 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?
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?
The results were analyzed by consensus error grid (CEG) (time frame: After 2 days of blood glucose measurements). 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 30 Aug 2023.