NCT07075796

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2025

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

July 10, 2025

Last Update Submit

January 9, 2026

Conditions

Diabetes Mellitus, Type 2

Keywords

non-invasive glucose measurementdiabetestipo 2glucometer

Outcome Measures

Primary Outcomes (2)

  • 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).

    4 times/day for 1 week

  • Performance Improvement Evaluation

    Improved performance of the GLUCUBE device as patient usage time increases.

    through study completion, an average of 21 days

Other Outcomes (1)

  • User Satisfaction

    21 days after the participant enters the study

Study Arms (1)

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).

Device: GLUCUBE system

Interventions

GLUCUBE systemDEVICE

A non-invasive system to monitor and measure the blood glucose compared to the standard glucometer in a group subjects

Open-Label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Especialidades Virgen de los Reyes. Hospital Universitario Virgen del Rocío

Seville, Seville, 41001, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 20, 2025

Study Start

June 2, 2025

Primary Completion

November 28, 2025

Study Completion

November 28, 2025

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

ES(1)