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NCT02521506 Clinical Trial

Clinical Efficacy of OneTouch® Verio™IQ Meter

Diabetes Mellitus Clinical Trial

— ECOVIQ  

Official title:
Clinical Efficacy of OneTouch® Verio™IQ Meter

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02521506
Other study ID # ECOVIQ
Secondary ID
Status Completed
Phase N/A
First received August 5, 2015
Last updated March 6, 2017
Start date March 2015
Est. completion date December 2016

Study information
Verified date December 2016
Source Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Verio Pattern Alert® activated

• Verio Pattern Alert® deactivated

Locations
Country Name City State
Spain Complejo Hospitalario Universitario A Coruña A Coruña
Spain Hospital Universitario Torrecárdenas Almería
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Universitario Virgen de la Victoria Málaga

Sponsors (1)
Lead Sponsor Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of hypoglycemic events Glucose levels under 70 mg/dL with or without clinical manifestation 20 months
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