Diabetes Mellitus, Type 2NCT07075796
Study of the Performance of the GLUCUBE System in Patients With Type 2 Diabetes
A study testing GLUCUBE system in people with Diabetes Mellitus, Type 2, run by iGluco at 1 site in Spain.
Trial summary
This study is a prospective, single center, open label clinical investigation. The primary objective of the study is to evaluate the performance of GLUCUBE in patients with diabetes type 2 and how the accuracy of the system improves as the time of use by the patient increases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GLUCUBE system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jun 2025to 28 Nov 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be ≥ 18 years of age.
- Diagnosed with type 2 diabetes mellitus.
- Have a smartphone with an internet connection that allows the installation of the GLUCUBE APP.
- Be able to use the GLUCUBE system autonomously, in the opinion of the researcher.
- Have signed the informed consent.
Who cannot join
- The patient is currently participating in another clinical investigation or has participated in another clinical investigation in the last 30 days prior to the start of this study.
- Pregnant or breast-feeding women and those subjects who plan pregnancy during the clinical investigation follow-up period.
- Presence of other anatomical or comorbid conditions, or other medical, social or psychological conditions that, in the opinion of the investigator, could limit the subject's ability to participate in the clinical investigation or to comply with the follow-up requirements, or affect the scientific soundness of the clinical investigation results.
- Patients with any active and/or infectious acute illness.
- Patients who have a condition that affects blood circulation in the fingers of the hand, such as Raynaud's phenomenon.
- Any medical condition that, in the opinion of the investigator, will increase the risk of hyperglycemic and hypoglycemic events: seizures, heart disease, unconscious hypoglycemia, etc.
Show all 9Show fewer
- Patients with an inability to maintain hand stability during measurement or with progressive nervous system disease affecting movement (Parkinson's disease, moderate-severe essential tremor, and other diseases with involuntary movements).
- Patients suffering from calluses, malformations, or open wounds with bandages on their hands.
- Patients with nail polish or any type of false nail.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro de Especialidades Virgen de los Reyes. Hospital Universitario Virgen del Rocío
Seville, Seville, 41001
About this study
This study is a prospective, single center, open label clinical investigation. The primary objective of the study is to evaluate the performance of GLUCUBE in patients with diabetes type 2 and how the accuracy of the system improves as the time of use by the patient increases.
Read the detailed description
Current methods of measuring blood glucose, glucometers, although minimally invasive, can be painful as they require puncturing the fingertip with a prick device and drawing a drop of blood, which is applied to a disposable test strip. This minimal invasiveness can cause discomfort and discourage the user from testing their blood glucose levels as frequently as necessary, leading to poor glycemic control. Due to the non-invasive nature of the GLUCUBE system, it provides glucose level information safely and painlessly, avoiding any discomfort to the user. It is low cost as it uses commonly used electronic components and does not require test strips or other consumables that would increase the ongoing cost of the device. The performance of the GLUCUBE system has already been evaluated in comparison to the standard glucometer (Ascensia Contour®Next) in adult patients with and without diabetes. The primary objective of this clinical investigation is to evaluate the performance of GLUCUBE in patients with diabetes type 2 and how the accuracy of the system improves as the time of use by the patient increases.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GLUCUBE system
- Keywords
- non-invasive glucose measurement, diabetes, tipo 2, glucometer
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLUCUBE systemDevice
A non-invasive system to monitor and measure the blood glucose compared to the standard glucometer in a group subjects
| Study group | Role | What they receive |
|---|---|---|
| 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 system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Evaluation
Performance of the GLUCUBE device in monitoring and measuring blood glucose in adult patients with type 2 diabetes, compared to the standard glucometer (capillary blood glucometer - Ascensia Contour®Next).
Measured: 4 times/day for 1 week
Performance Improvement Evaluation
Improved performance of the GLUCUBE device as patient usage time increases.
Measured: through study completion, an average of 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start2 Jun 2025
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- iGluco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075796
- Sponsor's protocol ID
- 2024-NIGM-004
- Status last verified
- Jan 2026
- First submitted
- 10 Jul 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amuedo S, Macias ME, Fornes JM, Arteaga AM, Barrau JR, Bellido V, Vinau FL, Pichardo LMH, Moreno AS, Moreno AP, Lopez AP. Real-World Evaluation of a Near-Infrared Spectroscopy-based Noninvasive Glucose Monitoring Device in Adults With Type 2 Diabetes. J Diabetes Sci Technol. 2026 Oct 25:19322968261496268. doi: 10.1177/19322968261496268. Online ahead of print.
PubMed 42926350
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Performance of the GLUCUBE System in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07075796
- Acronym / sponsor ID
- 2024-NIGM-004
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- non-invasive glucose measurement, diabetes, tipo 2, glucometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- iGlucoIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 20 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.
This study is a prospective, single center, open label clinical investigation. The primary objective of the study is to evaluate the performance of GLUCUBE in patients with diabetes type 2 and how the accuracy of the system improves as the time of use by the patient increases.
Detailed description
Current methods of measuring blood glucose, glucometers, although minimally invasive, can be painful as they require puncturing the fingertip with a prick device and drawing a drop of blood, which is applied to a disposable test strip. This minimal invasiveness can cause discomfort and discourage the user from testing their blood glucose levels as frequently as necessary, leading to poor glycemic control. Due to the non-invasive nature of the GLUCUBE system, it provides glucose level information safely and painlessly, avoiding any discomfort to the user. It is low cost as it uses commonly used electronic components and does not require test strips or other consumables that would increase the ongoing cost of the device. The performance of the GLUCUBE system has already been evaluated in comparison to the standard glucometer (Ascensia Contour®Next) in adult patients with and without diabetes. The primary objective of this clinical investigation is to evaluate the performance of GLUCUBE in patients with diabetes type 2 and how the accuracy of the system improves as the time of use by the patient increases.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label | Other | Device: GLUCUBE systemGLUCUBE 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be ≥ 18 years of age.
- Diagnosed with type 2 diabetes mellitus.
- Have a smartphone with an internet connection that allows the installation of the GLUCUBE APP.
- Be able to use the GLUCUBE system autonomously, in the opinion of the researcher.
- Have signed the informed consent.
Key exclusion criteria (9 listed)
- The patient is currently participating in another clinical investigation or has participated in another clinical investigation in the last 30 days prior to the start of this study.
- Pregnant or breast-feeding women and those subjects who plan pregnancy during the clinical investigation follow-up period.
- Presence of other anatomical or comorbid conditions, or other medical, social or psychological conditions that, in the opinion of the investigator, could limit the subject's ability to participate in the clinical investigation or to comply with the follow-up requirements, or affect the scientific soundness of the clinical investigation results.
- Patients with any active and/or infectious acute illness.
- 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 systemA non-invasive system to monitor and measure the blood glucose compared to the standard glucometer in a group subjects | Device | Open-Label |
Primary outcome
Performance Evaluation
Time frame: 4 times/day for 1 week
Performance of the GLUCUBE device in monitoring and measuring blood glucose in adult patients with type 2 diabetes, compared to the standard glucometer (capillary blood glucometer - Ascensia Contour®Next).
Performance Improvement Evaluation
Time frame: through study completion, an average of 21 days
Improved performance of the GLUCUBE device as patient usage time increases.
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 13 Jan 2026.
- Derived from this study: PubMed 42926350Amuedo S, Macias ME, Fornes JM, Arteaga AM, Barrau JR, Bellido V, Vinau FL, Pichardo LMH, Moreno AS, Moreno AP, Lopez AP. Real-World Evaluation of a Near-Infrared Spectroscopy-based Noninvasive Glucose Monitoring Device in Adults With Type 2 Diabetes. J Diabetes Sci Technol. 2026 Oct 25:19322968261496268. doi: 10.1177/19322968261496268. Online ahead of print.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 system in people with Diabetes Mellitus, Type 2, 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 5 inclusion and 9 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 13 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 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?
On the ClinicalTrials.gov record for NCT07075796, which also lists 1 linked publication.
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 13 Jan 2026.