Diabetes MellitusECOVIQNCT02521506
Clinical Efficacy of OneTouch® Verio™IQ Meter
A study testing Verio Pattern Alert® activated and Verio Pattern Alert® deactivated in people with Diabetes Mellitus, run by Fundación Pública Andaluza Progreso y Salud at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Verio Pattern Alert® activated and Verio Pattern Alert® deactivated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesSpain
- Study dates
- Mar 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña, 15006
Hospital Universitario Torrecárdenas
Almería, Almería, 04000
Hospital Clínico San Carlos
Madrid, Madrid, 28000
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29000
About this study
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Verio Pattern Alert® activated, Verio Pattern Alert® deactivated
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verio Pattern Alert® activatedDevice
Verio Pattern Alert® deactivatedDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Verio Pattern Alert® activated |
| Verio Pattern Alert® deactivated | Active comparator | In this cohort, the patients will monitoring the glucose levels with capillar glucometer. Receives: Device: Verio Pattern Alert® deactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of hypoglycemic events
Glucose levels under 70 mg/dL with or without clinical manifestation
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521506
- Sponsor's protocol ID
- ECOVIQ
- Acronym
- ECOVIQ
- Status last verified
- Dec 2016
- First submitted
- 5 Aug 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of OneTouch® Verio™IQ Meter
- ClinicalTrials.gov ID
- NCT02521506
- Acronym / sponsor ID
- ECOVIQ / ECOVIQ
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verio Pattern Alert® activated | Experimental | Device: Verio Pattern Alert® activatedIn 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 comparator | Device: Verio Pattern Alert® deactivatedIn this cohort, the patients will monitoring the glucose levels with capillar glucometer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verio Pattern Alert® activated | Device | Verio Pattern Alert® activated |
| Verio Pattern Alert® deactivated | Device | Verio Pattern Alert® deactivated |
Primary outcome
number of hypoglycemic events
Time frame: 20 months
Glucose levels under 70 mg/dL with or without clinical manifestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verio Pattern Alert® activated and Verio Pattern Alert® deactivated in people with Diabetes Mellitus, run by Fundación Pública Andaluza Progreso y Salud at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of hypoglycemic events (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.