Clinical Efficacy of OneTouch® Verio™IQ Meter (ECOVIQ)

Fundación Pública Andaluza Progreso y Salud

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Verio Pattern Alert® deactivated; Device: Verio Pattern Alert® activated

Study type: Interventional

Funder types: Other

Identifiers

NCT02521506

ECOVIQ

Details and patient eligibility

About

Diabetes mellitus is one of the most prevalent disease in the western world. The control of glucose levels has a big impact in the prevention of diabetes complications. The measure of glucose levels in capillary blood with glucometers is the gold standard to measure and control the glucose levels. Nowadays the glucometers become to more precise and sophisticated devices. One of the most notables advance is the inclusion of software that cam predicts glucose trends. This software has not be tested in routine clinical practice.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient diagnosed with diabetes mellitus 1 or 2
• Treatment with insulin regimen during at least 12 months
• Capability of performed 3 glucose measurement per day
• Levels of glycated hemoglobin (A1C) less than 10%

Exclusion criteria

• Patients diagnosed of mental disorders
• Patients included in structured therapeutic health 6 months before the inclusion
• Patients included in any clinical trial in the 4 months before the inclusion

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Verio Pattern Alert® activated

Experimental group

Description:

In this cohort, the patients will monitoring the glucose levels with capillar glucometer and they have activated the software Verio Pattern Alert® that could predict the glucose trends.

Treatment:

Device: Verio Pattern Alert® activated

Verio Pattern Alert® deactivated

Active Comparator group

Description:

In this cohort, the patients will monitoring the glucose levels with capillar glucometer.

Treatment:

Device: Verio Pattern Alert® deactivated