Clinical Efficacy of OneTouch® Verio™IQ Meter
ECOVIQ
1 other identifier
interventional
90
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Mar 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 5, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 7, 2017
December 1, 2016
1.8 years
August 5, 2015
March 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
number of hypoglycemic events
Glucose levels under 70 mg/dL with or without clinical manifestation
20 months
Study Arms (2)
Verio Pattern Alert® activated
EXPERIMENTALIn 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.
Verio Pattern Alert® deactivated
ACTIVE COMPARATORIn this cohort, the patients will monitoring the glucose levels with capillar glucometer.
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- Patients diagnosed of mental disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña, 15006, Spain
Hospital Universitario Torrecárdenas
Almería, Almería, 04000, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28000, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29000, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2015
First Posted
August 13, 2015
Study Start
March 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
March 7, 2017
Record last verified: 2016-12