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

March 6, 2017 updated by: Fundación Pública Andaluza Progreso y Salud
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruna
      • Almería, Spain, 04000
        • Hospital Universitario Torrecárdenas
      • Madrid, Spain, 28000
        • Hospital Clinico San Carlos
      • Málaga, Spain, 29000
        • Hospital Universitario Virgen de la Victoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Verio Pattern Alert® activated
Active Comparator: Verio Pattern Alert® deactivated
In this cohort, the patients will monitoring the glucose levels with capillar glucometer.
Device: Verio Pattern Alert® deactivated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of hypoglycemic events
Time Frame: 20 months
Glucose levels under 70 mg/dL with or without clinical manifestation
20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza Progreso y Salud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • ECOVIQ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Verio Pattern Alert® activated

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe