Clinical Efficacy of OneTouch® Verio™IQ Meter

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Verio Pattern Alert® activated; Device: Verio Pattern Alert® deactivated

• Registration Number: NCT02521506
• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-13
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verio Pattern Alert® activated	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.
Verio Pattern Alert® deactivated	Verio Pattern Alert® deactivated	In this cohort, the patients will monitoring the glucose levels with capillar glucometer.

Primary Outcome Measures

Name	Time	Method
number of hypoglycemic events	20 months	Glucose levels under 70 mg/dL with or without clinical manifestation

Trial Locations

Locations (4)

Hospital Universitario Torrecárdenas; 🇪🇸 Almería, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Complejo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain