Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/03/2017
Date assigned
29/03/2017
Last edited
15/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Type 2 diabetes mellitus (T2DM) is a long term condition where a person is unable to control their blood sugar (glucose) levels as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). Patients with T2DM have increased risk of developing problems with their circulation, such as heart attack, stroke or blockages in the arteries in the legs. As well as the damaging effects of high blood sugar levels, these risks are further increased by other factors, such as high blood pressure, high cholesterol and smoking. It is well founded that properly managing these factors can help lower the risks of circulatory system disease and increase chances of survival. This study is looking at a computer tool that aims to help doctors to make decisions about which sugar, blood pressure and cholesterol control goals are recommended in each patient’s case, and how best to achieve these goals. The aim of the study is to assess whether patient’s diabetes is better controlled when their physicians use this decision support program.

Who can participate?
Adults who have had T2DM for at least one year.

What does the study involve?
Participants attend a study visit at which their doctor uses the decision support program to make recommendations about how they could reduce their risk of circulation problems, such as through medication or lifestyle modifications using blood pressure readings and information about blood sugar and cholesterol levels. This information is used along with the doctor’s own judgment to see if patients should make any changes to how they manage their condition. After three months, patients return to the clinic in order to find out whether their blood pressure, blood sugar control and cholesterol levels have improved.
In a second part of the study, information is collected from participant’s medical records in order to assess how well their blood pressure, blood sugar and cholesterol were previously controlled.

What are the possible benefits and risks of participating?
There are no guaranteed benefits involved with participating in this study, although patients are expected to be gain better control of their blood pressure, cholesterol and blood sugar levels. There are no risks involved with participating.

Where is the study run from?
1. University Health Centre Dr. Castroviejo (Spain)
2. University Health Centre Reina Victoria (Spain)
3. University Hosptial La Paz (Spain)

When is the study starting and how long is it expected to run for?
June 2014 to October 2016

Who is funding the study?
Ministry of Health, Social Services and Equality (Spain)

Who is the main contact?
Dr Luis M Beltrán
luism.beltranromero@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luis M Beltrán

ORCID ID

http://orcid.org/0000-0001-8048-9106

Contact details

Hospital Universitario Virgen del Rocío
Servicio de Medicina Interna
Seville
41013
Spain
+34 67 987 80 80
luism.beltranromero@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HULP PI-1851

Study information

Scientific title

Electronic clinical decision support system and multifactorial risk factor control in patients with type 2 diabetes in primary health care

Acronym

ARTERIOTARGET Project-1

Study hypothesis

An electronic Clinical Decision Support System (eCDSS) that collects relevant clinical information and combines it with the CPG recommendations to provide personalised recommendations could be useful to improve the multifactorial control of patients with T2DM managed in primary care.

Ethics approval

The Ethics Committee at La Paz University Hospital (Madrid), 25/11/2014, ref: HULP PI-1851

Study design

Multi-centre interventional non-randomised study with a prospective phase (interventional) and retrospective phase (observational)

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

See additional files

Condition

Type 2 diabetes mellitus

Intervention

All participants attend a standard clinical visit in which their responsible physicians explain and propose the study. If they agree to take part, then blood pressure (BP) is measured and analysed and the physician uses the electronic decision support system (Arteriotarget) to advise recommendations in combination with their clinical judgement. If all vascular factors are well controlled or if the physician does not agree with Arteriotarget recommendations the patient did not receive any specific intervention. In any case a follow-up visit is scheduled at 12 weeks +/- 15 days and then blood pressure and laboratory parameters are reevaluated. Additionally patients are asked about clinical adverse events such hypoglycemia or hypotension.

In the second part of the study, medical records from 12 months to 3 months before baseline visit are reviewed for BP, LDLc, and HbA1c from the year before the study initiation to baseline.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Proportion of patients with T2DM with multi-factorial control of blood pressure, LDL cholesterol, and HbA1c is assessed through clinical examinations and blood testing at baseline and 12 weeks

Secondary outcome measures

1. Proportion of controlled patients for each individual factor (blood pressure, LDL cholesterol and HbA1c) is assessed through clinical examinations and blood testing at baseline and 12 weeks
2. Mean change in ystolic BP (SBP), diastolic BP (DBP), cLDL, and HbA1c is assessed through clinical examinations and blood testing at baseline and 12 weeks
3. Proportion of patients with potential adverse events attributable to intensification of treatment (glomerular filtration rate decrease >20%, CPK elevated 3 times the upper limit of normal [ULN], GPT elevated 3 times ULN, hypo- or hyperkalaemia, and hypoglycemia or hypotension episodes) is assessed through blood testing at 12 weeks and focused clinical interview (hypoglycaemia or hypotension episodes)
4. Primary care physicians’ satisfaction with the eCDSS is evaluated using an anonymous, semi-quantitative survey at the end of recruitment

Overall trial start date

30/06/2014

Overall trial end date

31/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 to 65 years
2. T2DM diagnosed at least one year before

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

159 (assuming a 10% patient loss)

Participant exclusion criteria

1. Over 65 years
2. Poor short-term prognosis according to clinical judgement (advanced comorbidities, frailty, and severe cognitive impairment)

Recruitment start date

01/02/2015

Recruitment end date

31/10/2015

Locations

Countries of recruitment

Spain

Trial participating centre

University Health Centre Dr. Castroviejo
Calle de Cándido Mateos, 11
Madrid
28035
Spain

Trial participating centre

University Health Centre Reina Victoria
Av. de la Reina Victoria, 21
Madrid
28003
Spain

Trial participating centre

University Hosptial La Paz
Paseo de la Castellana 261
Madrid
28046
Spain

Sponsor information

Organisation

Hospital Universitario La Paz

Sponsor details

Metabolic Vascular Unit
Paseo de la Castellana 261
Madrid
28046
Spain
+34 91 334 03 88
carolvelascoes@hotmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Ministry of Health, Social Services and Equality (Ministerio de Sanidad, Servicios Sociales e Igualdad)

Alternative name(s)

Ministry of Health, Social Services and Equality

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Spain

Results and Publications

Publication and dissemination plan

Planned publication in a relevant international peer-review journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from rosa.torres@salud.madrid.org and carolvelascoes@hotmail.com

Intention to publish date

01/05/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28747256

Publication citations

Additional files

Editorial Notes

15/11/2017: Publication reference has been added 06/04/2017: The participant information sheets have been uploaded.