Clinical Efficacy of OneTouch® Verio™IQ Meter | NCT02521506

Studies
Clinical Efficacy of OneTouch® Verio™IQ Meter

NCT02521506

Sponsor

Fundación Pública Andaluza Progreso y Salud

Status

Completed

Last Update Posted

Mar 7, 2017Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Verio Pattern Alert® activated
Verio Pattern Alert® deactivated

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Aug 5, 2015

First Submission Date that Met QC Criteria

Aug 7, 2015

First Posted Date

Aug 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2017

Last Update Posted Date

Mar 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Verio Pattern Alert® activated	Experimental	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
Verio Pattern Alert® deactivated	Active Comparator	In this cohort, the patients will monitoring the glucose levels with capillar glucometer.	Device: Verio Pattern Alert® deactivated

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Verio Pattern Alert® activated	Device		Verio Pattern Alert® activated
Verio Pattern Alert® deactivated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Complejo Hospitalario Universitario A Coruña		A Coruña	A Coruña	15006	Spain
Hospital Universitario Torrecárdenas

Type	Date	Date Unknown
Release	Feb 22, 2021
Reset	Mar 18, 2021

Submission Tracking

Estimated Results First Submitted Date

Feb 22, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 22, 2021			Mar 18, 2021

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided