Blood GlucoseNCT04935957
Study of GLUCUBE Performance, a Non-invasive System for Monitoring Blood Glucose Levels Based on Near Infrared Spectroscopy (NIRS) Technology.
A study testing GLUCUBE device in people with Blood Glucose, run by iGluco at 1 site in Spain.
Trial summary
This study is a prospective, single center, non-interventional, open label clinical investigation. The primary objective of the study is to evaluate the performance of GLUCUBE system compared to the standard glucometer in the determination of blood glucose level in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose
- What is being tested?
- GLUCUBE device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 11 Mar 2024to 15 May 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be ≥ 18 years old.
- Have a smartphone with an internet connection that allows the installation of GLUCUBE APP
- Have signed the informed consent.
Who cannot join
- Subject is currently participating in another clinical investigation or has participated in another clinical investigation in the past 30 days prior to the start of the present study.
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Patients with any acute active and/or infectious disease.
- Patients who have a condition that affects blood circulation in the fingers of the hand, such as Raynaud's phenomenon.
- Any medical condition that, by the investigator judgment, will increase the risk from hyper and hypoglycemic event: seizures, heart disease, hypoglycemia unawareness, etc.
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- Patients who, in the opinion of the investigator, do not have sufficient manual dexterity to perform the tests themselves.
- Patients with an inability to maintain stability of the hand during measurement or with progressive disease of the nervous system that affects movement (Parkinson's disease, moderate-severe essential tremor, and other diseases with involuntary movements).
- Patients suffering from calluses, malformations, or open wounds with bandages.
- Patients with nail polish or any type of false nail.
- Subjects who do not understand or cannot follow the Procedures Involved in the Use of the Device Under Investigation.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective, single center, non-interventional, open label clinical investigation. The primary objective of the study is to evaluate the performance of GLUCUBE system compared to the standard glucometer in the determination of blood glucose level in adult patients.
Read the detailed description
The current methods for blood glucose measurements, glucometers, although minimally invasive, can be painful, requiring puncturing the fingertip with a lancet device and removing a drop of blood, that applies to a disposable test strip. This minimal invasiveness may cause discomfort and deter the user from measuring his/her blood glucose levels as frequently as required. Due to GLUCUBE device non-invasive nature, it is expected to give the patient or health care provider immediate reliable quantitative as well as qualitative information, safely and painlessly avoiding any type of discomfort to the user.
This study is a prospective, single center, non-interventional, open label clinical investigation designed with a total amount of 105 subjects. Study participants will take the GLUCUBE device and standard glucometer home and each subject will take 4 pairs of measurements per day for a week.
- Conditions
- Blood Glucose
- Being tested
- GLUCUBE device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLUCUBE deviceDevice
Also called GLUCUBE
device to monitor and measure the blood glucose compared to the standard glucometer in a group subjects
| Study group | Role | What they receive |
|---|---|---|
| Non-interventional. Open Label. | Other | GLUCUBE system performance in the monitoring and measurement of the blood glucose compared to the standard glucometer (blood capillary glucometer - Bayer Contour®Next). Receives: Device: GLUCUBE device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Evaluation
GLUCUBE system performance in the monitoring and measurement of the blood glucose compared to the standard glucometer (blood capillary glucometer - Bayer Contour®Next).
Each pair of measurements includes one measurement with the standard glucometer (Bayer Contour®Next) and one measurement with GLUCUBE device.
Measured: 4 times/day for 1 week
Safety Evaluation
All (Serious) Adverse Events and GLUCUBE device related adverse events: local and systemic effects of GLUCUBE device, and the standard glucometer, including, but not limited to redness, burns, pain, or other complications such as bleeding or local infection will be collected.
Measured: All AE will be collected during participation in the study since V1 at V2 (8 days)
Secondary outcomes (1)
Performance Evaluation
GLUCUBE system performance in the monitoring and measurement of the blood glucose compared to the standardized POC device for the determination of glucose (Accu-Chek® Inform II system).
Each pair of measurements includes one measurement with standardized POC device for the determination of glucose (Accu-Chek® Inform II system) and one measurement with GLUCUBE device.
Measured: through study completion, an average of 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start11 Mar 2024
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- iGluco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935957
- Sponsor's protocol ID
- DIA-2021-01
- Status last verified
- Sep 2024
- First submitted
- 4 Jun 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of GLUCUBE Performance, a Non-invasive System for Monitoring Blood Glucose Levels Based on Near Infrared Spectroscopy (NIRS) Technology.
- ClinicalTrials.gov ID
- NCT04935957
- Acronym / sponsor ID
- DIA-2021-01
- Conditions
- Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- iGlucoIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 23 Jun 2021 (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 study is a prospective, single center, non-interventional, open label clinical investigation. The primary objective of the study is to evaluate the performance of GLUCUBE system compared to the standard glucometer in the determination of blood glucose level in adult patients.
Detailed description
The current methods for blood glucose measurements, glucometers, although minimally invasive, can be painful, requiring puncturing the fingertip with a lancet device and removing a drop of blood, that applies to a disposable test strip. This minimal invasiveness may cause discomfort and deter the user from measuring his/her blood glucose levels as frequently as required. Due to GLUCUBE device non-invasive nature, it is expected to give the patient or health care provider immediate reliable quantitative as well as qualitative information, safely and painlessly avoiding any type of discomfort to the user.
This study is a prospective, single center, non-interventional, open label clinical investigation designed with a total amount of 105 subjects. Study participants will take the GLUCUBE device and standard glucometer home and each subject will take 4 pairs of measurements per day for a week.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-interventional. Open Label. | Other | Device: GLUCUBE deviceGLUCUBE system performance in the monitoring and measurement of the blood glucose compared to the standard glucometer (blood capillary glucometer - Bayer Contour®Next). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be ≥ 18 years old.
- Have a smartphone with an internet connection that allows the installation of GLUCUBE APP
- Have signed the informed consent.
Key exclusion criteria (11 listed)
- Subject is currently participating in another clinical investigation or has participated in another clinical investigation in the past 30 days prior to the start of the present study.
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Patients with any acute active and/or infectious disease.
- Patients who have a condition that affects blood circulation in the fingers of the hand, such as Raynaud's phenomenon.
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 |
|---|---|---|
| GLUCUBE deviceAlso: GLUCUBEdevice to monitor and measure the blood glucose compared to the standard glucometer in a group subjects | Device | Non-interventional. Open Label. |
Primary outcome
Performance Evaluation
Time frame: 4 times/day for 1 week
GLUCUBE system performance in the monitoring and measurement of the blood glucose compared to the standard glucometer (blood capillary glucometer - Bayer Contour®Next). Each pair of measurements includes one measurement with the standard glucometer (Bayer Contour®Next) and one measurement with GLUCUBE device.
Safety Evaluation
Time frame: All AE will be collected during participation in the study since V1 at V2 (8 days)
All (Serious) Adverse Events and GLUCUBE device related adverse events: local and systemic effects of GLUCUBE device, and the standard glucometer, including, but not limited to redness, burns, pain, or other complications such as bleeding or local infection will be collected.
1 secondary outcome
Performance Evaluation
Time frame: through study completion, an average of 8 days
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 19 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLUCUBE device in people with Blood Glucose, run by iGluco at 1 site in Spain.
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 3 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 19 Sep 2024. 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 Spain. 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?
Performance Evaluation (time frame: 4 times/day for 1 week). The study lists 2 primary outcomes in all. 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 19 Sep 2024.