ORIGINAL INVESTIGATION Open Access
Multifactorial control and treatment intensity of
type-2 diabetes in primary care settings in
Catalonia
Lucas Mengual
1†
, Pilar Roura
1†
, Marta Serra
2†
, Montserrat Montasell
3†
, Gemma Prieto
4†
, Sandra Bonet
5*†
Abstract
Background: Many studies on diabetes have demonstrated that an intensive control of glycaemia and the main
associated risk factors (hypertension, dislipidaemia, obesity and smoking) reduce cardiovascular morbi-mortality.
Different scientific societies have proposed a multifactorial approach to type 2 diabetes.
The objective of this study was to identify the degree of control of glycosylated haemoglobin (HbA1c) and of car-
diovascular risk factors in type 2 diabetic patients, using the GedapS 2004 guidelines, and to analyse the type and
intensity of drug treatment.
Methods: This cross-sectional, multicentre, epidemiological study was conducted in a primary care setting in Vallès
Occidental South, Catalonia. Data were collected of 393 patients aged 18 and above who were diagnosed with
diabetes mellitus type 2. Biodemographic and clinical data, cardiovascular risk factors, associated cardiovascular
disease, and treatment were assessed. Descriptive and multivariable analysis with logistic regression was realized.
Results: A total of 392 patients with a mean age of 66.8 years (SD = 10.6) (45.4% male patients) were analyzed.
The duration of diabetes was 8.4 years (SD = 7.6). The degree of multifactorial control of risk factors was only 2.6%,
although in more than 50% individual cardiovascular risk factor was controlled, except for LDL cholesterol (40.6%)
and systolic blood pressure (29.6%). Furthermore, only 13.0% of subjects had an optimal BMI, 27.5% an optimal
waist circumference. Treatment for diabetes was prescribed in 82.7% of patients, for hypertension 70.7%, for
dyslipidaemia 47.2% and 40.1% were taking antiplatelets.
Conclusion: Over 50% of type 2 diabetic patients presented optimal control of the majority of individual
cardiovascular risk factors, although the degree of multifactorial control of diabetes was insufficient (2.6%) and
should be improved. Drug treatment can be intensified using a larger number of combinations, particularly in
patients with target organ damage and associated clinical cardiovascular disease.
Background
Diabetes mellitus (DM) is a chronic disease with a pre-
valence of 4.5% - 18.5% in Spain [1]. According to the
World Health Organisation (WHO), the prevalence of
diabetes in Spain was expected to increase by as much
as 40% between 2000 and 2025 [2]. DM is the seventh
leading cause of death in Spain [3].
Several studies [4-7] in diabetic patients have shown
that close control of glycaemia and the main cardiovas-
cular risk factors, such as arterial hypertension (AHT),
dyslipidaemia, obesity and smoking, reduces cardiovas-
cular morbimortality.
Furthermore, the United Kingdom Prospective Dia-
betes Study (UKPDS) has shown that for every 1%
reduction in glycosylated haemoglobin (HbA1c) there is
a decrease in any DM-related complication and in mor-
tality [8]. However, recent studies [9-11] recommend
that HbA1c levels of 7% should be achieved and main-
tained in adult patients, without dropping below 6.5%.
Based on current evidences, different scientific socie-
ties have proposed using an approach using multifactor-
ial control of risk factors in patients with type-2
diabetes (DM2)[12-14].
* Correspondence: sandrabonet@adknoma.com
†Contributed equally
5
Adknoma Health Research, Barcelona, Spain
Mengual et al.Cardiovascular Diabetology 2010, 9:14
http://www.cardiab.com/content/9/1/14
CARDIO
VASCULAR
DIABETOLOG
Y
© 2010 Mengual et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
Despite these recommendations [14,15], multifactorial
control of risk factors in diabetes is still insufficient
[16-18]. Thus, for example, Mostaza et al [19], reported
that optimal control of all risk factors was found in just
7% of diabetic patients. The current consensus is that
diabetic patients should be seen at a primary care centre
for the purpose of prevention and control [20], and this
is also ratified by the WHO document [21]. In this con-
text, our study was aimed to identify the degree of con-
trol of HbA1c and multifactorial control of risk factors
in type 2 diabetic patients, using the GedapS 2004
guidelines [22].
Methods
Study design and population
The study had a cross-sectional, multicentre, epidemio-
logical design. It focused on primary care in normal
clinical practice provided in the Vallès Occidental South
region in the north of the province of Barcelona. The
region had a population of 429,816 persons. Forty physi-
cians were selected using simple randomisation from a
total of 186 physicians belonging to 16 primary care
teams in 8 towns in the zone. The physicians who
agreed to participate in the study were given a specific
training session to explain the study objectives, proce-
dures, and, in particular, how to collect data and record
it in the Case Report Form (CRF). The study was
approved by the Institutional Review Board of the Jordi
Gol Institute for Research in Primary Care (Institut d’In-
vestigació en Atenció Primària Jordi Gol; IDIAP Jordi
Gol).
The patients were recruited according the following
selection criteria:
Inclusion criteria
patients aged 18 and above diagnosed of DM2 at least 6
months prior to study inclusion and who had given
informed consent to participate in the study.
Exclusion criteria
patients with type 1 diabetes mellitus (DM1), patients
with DM2 in a terminal phase and those with a severely
deteriorated quality of life or who would have had diffi-
culty in attending the centre during the study period,
and patients who, in the investigator’sopinion,pre-
sented any condition which could hinder their participa-
tion (communication problems, cognitive or sensorial
disorder, language barrier and severe psychiatric
disorders).
The sample size was calculated in terms of the pri-
mary objective (to determine the degree of control of
HbA1c in patients with type-2 diabetes attended at pri-
mary care in Vallès Occidental South, using the GedapS
2004 guidelines). A previous study (TranSTAR study)
[17], found that HbA1c was controlled in 18.8% of
patients. Using the binomial distribution, 390 patients
with type-2 diabetes would provide an accuracy of 4%
for estimating the proportion of diabetic patients with
good HbA1c control, with a 95% confidence interval,
assuming that 10% of patients would not be valid for
the analysis.
Data collection
Between July 2007 and January 2008, each physician
included the first diabetic patient attending his/her pri-
mary care practice who met the inclusion criteria, up to
a total of 10 patients per physician in the course of 10
days.
The following study variables were recorded in an
electronic CRF, applying internal consistency rules to
ensure data quality control: biodemographic data (age,
sex, weight, height, waist circumference, year of diag-
nose with DM2), physical exercise (hours/week), cardio-
vascular risk factors, associated cardiovascular disease,
smoking habit, clinical data (blood pressure, heart rate,
blood tests, kidney function, proteinuria, glycaemic and
lipid profile) and treatments (antidiabetics, antihyperten-
sives, antidyslipidaemics, antiplatelets, anticoagulants).
Measurement and diagnostic criteria
Normal values
We used the normal values recommended in the Eur-
opean Guidelines [23] for blood pressure (BP), obesity,
sedentary lifestyle, smoking and alcohol.
Blood pressure (BP)
It was measured as recommended by the ESH-ESC
guidelines [24]. BP was recorded twice per visit and the
mean value calculated.
Waist circumference
It was measured in centimetres with a tape measure at
the midpoint between the lower part of the last rib and
the top of the iliac crest.
Left ventricular hypertrophy
It was assessed following ESH-ESC guidelines [24]:
Sokolow criteria (SV1+RV5-6>38 mm), Cornell criteria
(RaVL+SV3>28 in men and 20 in women) or by
echocardiography.
Body Mass Index (BMI)
The BMI is used to classify a person’s weight status. It is
calculated using the formula: weight (kg)/height (m
2
).
Dyslipidaemia
It was diagnosed following the criteria set out in the
clinical guidelines [25], which consider to be indicative
of hypercholesterolaemia a total cholesterol level of ≥
200 mg/dL in primary prevention, or an LDL-cholesterol
level of ≥100 mg/dL in secondary prevention.
Cardiovascular Risk
It was calculated using Framingham Risk Tables [26]
which estimate the 10-year risk of suffering a coronary
event, angina or fatal or non-fatal myocardial infarction.
Mengual et al.Cardiovascular Diabetology 2010, 9:14
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Low cardiovascular risk was considered as less than 5%,
slight risk as 5-9%, moderate risk as 10-19%, high risk
as 20-39% and very high risk as over 39%.
Objective
Study’s primary objective was to determine the degree of
control of HbA1c and multifactorial control of risk fac-
tors in type 2 diabetic patients, using the GedapS 2004
guidelines [22]. This guideline consider good control as
fulfilment of the following conditions: HbA1c lower
than 7%, total cholesterol lower than 200 mg/dL, LDL
cholesterol lower than 100 mg/dL, HDL cholesterol
higher than 40 mg/dL, triglycerides (TG) lower than
150 mg/dL, systolic blood pressure (SBP) lower
than 130 mmHg, diastolic blood pressure (DBP) lower
than 80 mmHg and not smoking. When all these condi-
tions are fulfilled simultaneously, it can be considered
that a patient has good multifactorial control. This
guideline also recommends a body mass index (BMI)
between 18.5 and 24.9 kg/m
2
and a waist circumference
of less than 102 cm for men and 88 cm for women.
Statistical methodology
Allanalyseswereperformedonasinglesampleofdia-
betic patients. Evaluable patients were all those who met
the selection criteria and had a recorded value of the
principal study variable (HbA1c). The qualitative vari-
ables were described using absolute and relative fre-
quencies, whereas the quantitative variables were
described using their mean, standard deviation, median,
minimum and maximum, including the total number of
valid values. Parametric tests (Student’storANOVA)
or non-parametric tests (Mann-Whitney or Kruskal-
Wallis) were used to compare quantitative variables for
patient subgroups, depending on the characteristics of
the variable being studied. The chi-squared test was
used for qualitative variables. Logistic regression was
performed to assess the association between good DM2
control (HbA1c) and the independent variables found to
be of interest in the bivariate analysis. All statistical ana-
lyses were performed with a two-tailed confidence level
of 95%. The SAS statistical package was used (version
9.1.3).
Results
Clinical and analytical characteristics
A total of 393 patients with DM2 were recruited,
although one was subsequently excluded as the principal
study variable was not specified, to give a final total of
392 patients. The mean age was 66.8 years (SD = 10.6).
54.6% were women.
The mean duration of DM2 was 8.4 years (SD = 7.6).
44.8% of patients were obese (BMI ≥30). The mean
BMI was 29.3 kg/m
2
in men and 30.6 kg/m
2
in women
(p < 0.01). Waist circumference was higher than recom-
mended (≥102 cm in men and ≥88 cm in women) in
51.4% of the men and 83.1% of the women; this differ-
ence was statistically significant (p < 0.05). A total of
11.1% of the patients were active smokers, 81.3% of
whom were male (44.2% ≤60 years of age).
As regards physical activity, more than half the sample
(59.0%) undertook regular physical exercise (walking as
a minimum) for about one hour an average of 5 days
per week.
When we analysed the degree of control of cardiovas-
cular risk factors, individually, the majority had good
control of over 50%. It should be noted that 54.8% of
thesamplehadaHbA1cvalueoflessthan7%.Factors
that had poor control included SBP < 130 mmHg
(29.6%), LDL cholesterol < 100 mg/dL (40.6%), BMI <
25 (13.1%) and waist circumference < 102 cm in men
and 88 cm in women (27.5%) (Figure 1). The most rele-
vant clinical characteristics are listed in Additional file
1. Good BP control (SBP < 130 and DBP < 80) was
found in 24.7% of the sample. All cardiovascular risk
factors were well controlled in just 2.6% of the diabetic
patients in this study, using the criteria set out in
GedapS 2004.
Cardiovascular Risk: Cardiovascular risk factors and
associated complications
Cardiovascular risk (CVR), as determined using the Fra-
mingham Risk Tables, showed that 23.2% of patients
presented a low risk, 37.5% a slight risk, 30.1% a moder-
ate risk, 8.4% a high risk and 0.8% a very high risk.
The most prevalent cardiovascular risk factors were
AHT (73.0%), dyslipidaemia (58.2%) and obesity (44.8%).
Microvascular complications were present in 26.0% of
patients, the most common being nephropathy (17.8%;
(13.5% with microalbuminuria and 3.7% with protei-
nuria)) and retinopathy (12.1%).
Macrovascular complications were present in 24.5% of
the sample, with ischaemic cardiopathy (12.5%) and per-
ipheral arteriopathy (11.0%) being the most prevalent. In
all, 44.9% of the sample had some type of target organ
damage and/or clinical cardiovascular disease.
Factors associated with control of HbA1c
In the bivariate analysis, factors associated with a good
control of HbA1c (<7%) to a statistically significant
degree (p < 0.05) were: shorter history of DM2; female
patients; lower SBP level; lower triglycerides (TG) level;
lower albumin level in urine; higher LDL cholesterol;
less intensive treatment for DM2, dyslipidaemia and
antiplatelets; and lower CVR (Additional file 2).
The logistic regression analysis showed that the prob-
ability of good HbA1c control (<7%) was 4.09-fold
higher in patients taking one or two antidiabetic drugs
Mengual et al.Cardiovascular Diabetology 2010, 9:14
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compared with those taking more than two antidiabetic
drugs. Furthermore, this probability was 2.62-fold higher
in patients with no retinopathy than in those with
retinopathy.
Drug treatment description
82.7% of patients in this study took antidiabetic drugs.
52.8% of them were on monotherapy (59.2% on metfor-
min) and 47.2% took a combination therapy. 14.9% of
patients had insulin treatment either alone or in combina-
tion with oral drugs. Likewise, 70.7% of patients took anti-
hypertensives (93.4% of patients diagnosed with AHT),
either in monotherapy (42.2%) or combination therapy
(57.8%). 47.2% were being treated for dyslipidaemia (75.9%
of patients diagnosed with dyslipidaemia), 40.1% were tak-
ing antiplatelet drugs and 5.6% anticoagulants (Additional
3). As regards the cardiovascular risk, 16.7% of patients
considered to be at high or very high risk (≥20) were not
taking any treatment for DM2, 22.2% were not on antihy-
pertensives, 52.8% were not receiving treatment for dysli-
pidaemia and 55.6% were not on antiplatelets.
With regard to treatment intensity and the presence of
target organ damage and/or clinical cardiovascular dis-
ease, there was significantly higher treatment intensity
for hypertension and anti-platelets. There were no dif-
ferences in treatment intensity for diabetes and dyslipi-
daemia (Additional file 4).
Of the patients with HbA1c ≥7%, 31.2% were being
treated with one oral drug and 64.6% were on combina-
tion therapy, 39.4% of whom were taking two oral
drugs, 2.9% taking three, 18.2% one oral drug plus insu-
lin and 4.2% insulin combinations. Finally, 20.7% of
patients presented kidney disease, 72.8% of whom were
taking angiotensin converting enzyme inhibitors (ACEI)
or angiotensin II receptor blockers (ARB).
Discussion
The primary objective of the DM2VALLES study was to
identify the degree control of HbA1c, the degree of indi-
vidual and multifactorial control of risk factors in type 2
diabetic patients attended at primary care centres.
According to other studies [19,27] we only found good
simultaneous control of all risk factors in 2.6% of the
study population, although there was good control of
individual factors such as HbA1c, total cholesterol, HDL
cholesterol, TG, DBP and smoking habit. The hardest
parameters to control were SBP and LDL cholesterol, as
also reported previously [27,28].
Figure 1 Degree of cardiovascular risk factor control according to GedapS 2004 in the DM2VALLES study population. Adequate control:
Hb1Ac < 7%; Cholesterol < 200 mg/dl; LDL < 100 mg/dl; HDL > 40 mg/dl; TG < 150 mg/dl; SBP/DBP < 130/80 mmHg; BMI: 18.5-249 kg/m2;
Waist circumference < 102 cm in men and < 88 cm in women.
Mengual et al.Cardiovascular Diabetology 2010, 9:14
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The degree control of HbA1c was found to be related
to the duration of diabetes. This control worsened with
length of illness due to the progressive deterioration of
the beta cells, as reported by other authors [4,5,18]. The
high percentage of patients with good HbA1c control
found in our study contrasts the values obtained in
other studies, despite their similar duration of diabetes
(8.4 years) [18]. This may be explained by the health
policy that has been implemented in this area for several
years on intervention and control in diabetes.
One important finding which should be highlighted is
the high number of patients with a BMI of ≥30 kg/m2
(44.8%), a figure which is similar to those found in pre-
vious studies [18,29,30] and which also contributes to
the poor multifactorial control of our patients. Indeed,
weight loss can result in as much as 0.5 reductions in
the HbA1c percentage [12] since a reduction in body fat
is associated with reduced insulin resistance and there-
fore better glycaemic control.
The benefits of regular physical exercise in the general
population, and in diabetic patients in particular, are
well known. Indeed, exercise is a key component in the
treatment of diabetes, together with diet, as it also helps
to improve cardiovascular risk factors [12,13]. Our study
showed positive results in this area, because over half
the study population exercised on a regular basis.
The number of smokers in our sample was lower than
in other studies, although the prevalence of smoking in
diabetic male subjects under the age of 60 was higher
than in the general population in Catalonia [16]. Con-
trolling this risk factor should be prioritized in diabetics
in light of the relationship between smoking and micro-
and macrovascular complications and mortality [13,22].
The prevalence of nephropathy, retinopathy, ischaemic
cardiopathy, stroke and peripheral arteriopathy observed
in our study was similar to that observed in other stu-
dies carried out recently in Spain [18,29].
Although patients with DM2 are characterised by their
high level of cardiovascular risk, our results based on
the Framingham Risk Tables showed that, in contrast to
previous studies [28,29,31], the majority of the sample
(60.7%) had a low or slight risk (<10%). These findings
are a result of the good individual control of the major-
ity of the cardiovascular risk factors presented by the
patients in our study.
Asregardstreatment,wefoundthatthemajorityof
patients were taking antidiabetics, with good control of
HbA1c levels in more than 50% of the sample. However,
we found a low use (15.6%) of insulin in monotherapy
or combination therapy. The number of patients receiv-
ing insulin treatment varies considerably from one study
to another. Thus, the percentage is as low as 9.6% in
some cases, and in others it is almost twice higher
(approximately 30%) [18,27,28].
An adequate control of LDL cholesterol level
(<100 mg/dL) was observed in 40.6% of patients, which
is notably higher than the low values reported in other
studies also conducted in primary care settings [27,28].
Despite the findings of studies such as ATP III [32] and
CARDS [33] which recommend pharmacological treat-
ment, only 47.2% of our patients were on treatment for
dyslipidaemia. The use of a more intensive treatment
than hypolipidaemic drugs in diabetic patients should
therefore be considered [13].
Although 70.7% of the sample was on antihypertensive
treatment, only 24.7% presented good blood pressure
control (<130/80 mmHg). In our study, 57.8% of
patients were taking combinations of antihypertensive
drugs. The review by Bakris et al.[34] showed that com-
bination therapy with two or more drugs is required for
good BP control in diabetic patients, which suggests
that the patients in our study were being inappropriately
treated in this respect and their treatment should be
intensified by either increasing the dose or using combi-
nations of drugs. A quarter of diabetic patients with kid-
ney disease were not being treated with either ACEIs or
ARB despite the fact this practice is recommended in
the literature because these drugs have been shown to
slow advancing kidney damage [35].
Antiplatelet treatment was being used in 40.1% of all
patients, a similar value to that reported in other studies
[16,27] and it was being used by 44.4% of patients in the
high cardiovascular risk group. Indication for this treat-
ment in primary prevention is currently controversial [36].
In the group of patients with high cardiovascular risk
(≥20), where intensified treatment is particularly indi-
cated, a high percentage were either receiving no drug
treatment (16.7% for DM2, 22.2% for AHT, 52.8% for
dyslipidaemia, 55.6% for antiplatelet agents) or only
monotherapy (38.9% for DM2 and 36.1% for AHT).
Treatment should also be intensified in patients with
target organ damage and/or clinical cardiovascular dis-
ease, because many patients in these groups are not on
treatment, or they are on monotherapy.
With regard to the limitations of our study, it should
first be noted that the study population was recruited
from a metropolitan area of Barcelona, which limits its
validity to urban areas. Second, the study sample was cho-
sen from a population seeking primary care. This means
that we were unable to analyse the characteristics of dia-
betic patients who do not attend such primary care setting,
although it the centres participating in this study have all
been operating for more than 10 years and they cover
more than 90% of the diabetic population in the region.
Conclusions
The results of this study suggest that there is still room for
improvement in the clinical and therapeutic management
Mengual et al.Cardiovascular Diabetology 2010, 9:14
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Page 5 of 7
of patients with type-2 diabetes attended at primary care
centres in our area. The purpose of this would be to
achieve good multifactorial control of all risk factors,
because previous studies [4,5] have shown that this strat-
egy is beneficial in slowing down or preventing the appear-
ance of chronic complications of type-2 diabetes. The
elevated level of obesity that we observed in our study sug-
gests that we should strengthen populational strategies
aimed at improving the healthy lifestyle of the population.
Additional file 1: Clinical and analytical characteristics in the
DM2VALLES study population. SD: Standard deviation, BMI: Body mass
index; SBP: Systolic blood pressure; DBP: Diastolic blood pressure.
Additional file 2: Factors associated with glycosylated haemoglobin
control in the DM2VALLES study population.
1
Chi-squared test;
2
Mann-Whitney U test; BMI: Body mass index; HbA1c: Glycosylated
haemoglobin; SBP: Systolic blood pressure; DBP: Diastolic blood pressure;
CVR: Cardiovascular risk; DM2: Diabetes mellitus type 2.
Additional file 3: Treatment for the cardiovascular risk factors in the
DM2VALLES study population. ASA: Acetylsalicylic acid; ARB:
Angiotensin-II receptor blockers; ACEI: Angiotensin converting enzyme
inhibitors.
Additional file 4: Treatment intensity and the presence of target
organ damage and/or clinical cardiovascular disease in the
DM2VALLES study population.
1
Chi-squared test; DM: Diabetes
Mellitus; AHT: Arterial hypertension; TOD + CCD: target organ damage
and/or clinical cardiovascular disease.
Acknowledgements
We would like to thank Jordi Gol i Gurina Institution and Laboratories
Boehringer Ingelheim for supporting this study and the following
researchers for collecting the data: Jordana Baron, Ana; Traveria Solas,
Miquel; Mampell, Manel; Vidal Farell, Montserrat; San Jose Mataro, Joaquim;
Yuste Marco, M
a
del Carmen; Bonet Simó, Josep Maria; Gasulla Pascual,
Griselda; Magem, Joan; Bel, Carme; Rubio Villar, Montserrat; Garcia Lopez, M
a
Carmen; Gallego Laredo, Francico Javier; Cruz Cubells, Lourdes; Martinez
Artes, Xavier; Hernández Alapáñez, Elisabeth; Ferreres Pi, Concepcion; Ortega
González, Raquel; Acosta Sosa, Iliana; Quiñones Ruiz, Sagrario; Soler Carbó,
Montserrat; López Lifante, Victor Miguel; Herranz Fernandez, Marta; Mazarico,
Tomas; Tomás Lachos, Montserrat; Farre Trepat, Neus; Pablos Herrero, Eva;
Cánovas Garrido, M
a
Carmen; Vilà Moneny, Jordi; Rebagliato i Nadal, Oriol;
Catarineu Almansa, Berta; Salido Cano, Antonio; Ayala Mitjavila, Rita.
Author details
1
Health Care Centre Badia del Vallès, Badia del Vallès, Barcelona, Spain.
2
Health Care Centre Ca n’Oriac, Sabadell, Barcelona, Spain.
3
Health Care
Centre Rosa dels Vents, Barberà del Vallès, Barcelona, Spain.
4
Unitat de
Suport a la Recerca, Ámbito Centro, Barcelona, Spain.
5
Adknoma Health
Research, Barcelona, Spain.
Authors’contributions
All authors participated in the design and the coordination of the study,
reviewed the statistical analysis and participated in writing the manuscript.
They all read and approved the final manuscript.
Competing interests
The authors declare that they have no competing interests.
Received: 21 September 2009 Accepted: 29 March 2010
Published: 29 March 2010
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doi:10.1186/1475-2840-9-14
Cite this article as: Mengual et al.: Multifactorial control and treatment
intensity of type-2 diabetes in primary care settings in Catalonia.
Cardiovascular Diabetology 2010 9:14.
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