Clinical Efficacy of OneTouch® Verio™IQ Meter

NCT ID: NCT02521506

Last Updated: 2017-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Verio Pattern Alert® activated

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.

Group Type EXPERIMENTAL

Verio Pattern Alert® activated

Intervention Type DEVICE

Verio Pattern Alert® deactivated

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

Group Type ACTIVE_COMPARATOR

Verio Pattern Alert® deactivated

Intervention Type DEVICE

Interventions

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Verio Pattern Alert® activated

Intervention Type DEVICE

Verio Pattern Alert® deactivated

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Pública Andaluza Progreso y Salud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña, Spain

Site Status

Hospital Universitario Torrecárdenas

Almería, Almería, Spain

Site Status

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Site Status

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Site Status

Countries

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Spain

Other Identifiers

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ECOVIQ

Identifier Type: -

Identifier Source: org_study_id

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