Diabetic foot disease carries an intrinsic high risk of mortality and other severe outcomes in type 2 diabetes: a propensity score-matched retrospective population-based study.

BACKGROUND: To evaluate the association between diabetic foot disease (DFD) and the incidence of fatal and non-fatal events in individuals with type 2 diabetes (T2DM) from primary-care settings. METHODS: We built a cohort of people with a first DFD episode during 2010-2015, followed up until 2018. These subjects were 1 to 1 propensity score matched to subjects with T2DM without DFD. The incidence of all-cause mortality, the occurrence of new DFD, amputations, cardiovascular diseases, or composite outcome, including all-cause mortality and/or cardiovascular events during the follow-up period, were calculated. A Cox proportional hazard analysis was conducted to evaluate the hazard ratios (HR) for different events. RESULTS: Overall, 11,117 subjects with T2DM with a first episode of DFD were compared with subjects without DFD. We observed higher incidence rates (IRs) for composite outcome (33.9 vs. 14.5 IR per 100 person-years) and a new DFD episode event (22.2 vs. 1.1 IR per 100 person-years) in the DFD group. Compared to those without DFD, those with a first episode of DFD had a higher HR for all events, with excess rates particularly for amputation and new DFD occurrence (HR: 19.4, 95% CI: 16.7-22.6, HR: 15.1, 95% CI: 13.8-16.5, respectively) was found. CONCLUSIONS: Although DFD often coexists with other risk factors, it carries an intrinsic high risk of morbidity and mortality in individuals with T2DM. DFD should be regarded as a severe complication already at its onset, as it carries a poor clinical prognosis.

Epidemiology of the first-ever cardiovascular event in people with type 1 diabetes: a retrospective cohort population-based study in Catalonia.

BACKGROUND: Knowledge of the characteristics of first-ever cardiovascular events in type 1 diabetes may impact primary prevention strategies. This study describes the first-ever manifestation of cardiovascular disease (CVD) in patients with type 1 diabetes (T1D) in Catalonia (Spain) and evaluates differences according to age and sex. METHODS: Retrospective cohort study of patients with T1D > 30 years without CVD before 2010 registered in the SIDIAP database. The occurrence of a first cardiovascular event up to the end of 2016, the type of CV event and associations with baseline characteristics were analysed. RESULTS: Of 8412 patients, 884 suffered a first CV event (incidence rate 1.62 per 100 persons-years). Overall, peripheral vascular disease (39.5%) was the most frequent event. We observed a higher proportion of heart failure in women (21.7%) than in men (10.1%). In women, heart failure was the most frequent event in those > 65 years (40.5%). Decreased glomerular filtration rate (hazard ratio [HR] 5.42 [95% CI 4.32;6.80]), elevated albumin/creatinine ratio (HR 3.39 [95% CI [2.47;4.66], microvascular complications (HR 3.27 [95% CI 2.85;3.75]), and hypertension (HR 3.21 [95% CI [2.80;3.67]) were most strongly associated with a first CV event. HbA1c > 7.0% was associated with incident CVD only in patients aged < 55/60 years. CONCLUSIONS: Peripheral artery disease in the whole cohort, and heart failure in elder subjects are the most frequent first-ever CVD events in T1D in our region. These findings deserve to be taken into account when considering primary prevention measures and when estimating CV risk in people with T1D.

A multicomponent health care intervention is associated with improved glycaemic control in subjects with poorly controlled type 2 diabetes compared with routine care: The INTEGRA study.

AIM: The INTEGRA study evaluated whether a specially designed multicomponent health care intervention improved glycaemic control in subjects with poorly controlled type 2 diabetes compared with standard of care practice. RESEARCH DESIGN AND METHODS: Pragmatic study in subjects from primary care centres with type 2 diabetes and glycated haemoglobin (HbA1c) >9% (75 mmol/mol). The multifaceted intervention (N = 225 subjects) included a diabetes-focused visit encouraging therapeutic intensification by health care professionals. Retrospective data from matched controls (N = 675) were obtained from electronic medical records of a primary care database. The primary outcome was to compare the change in HbA1c values between the groups at 12 months of follow-up. RESULTS: The mean HbA1c decreased substantially in both groups after 3 months, and the mean reduction was significantly greater in the intervention group than in the usual care group after 12 months [mean difference -0.66% (-7 mmol/mol), 95% CI -0.4, -1.0; p < .001]. A larger percentage of participants in the intervention group achieved HbA1c <7% and <8% goals (15.5% vs. 5.3% and 29.3% vs. 13.5%, respectively; p < .001). The improvement in HbA1c levels was sustained throughout the study only in the intervention arm. Glucose-lowering therapy was more frequently intensified in patients in the intervention group at the initial and final time points of the study (between 0-3 and 6-12 months; p < .001), with a significant increase in the number of patients prescribed ≥2 antidiabetic therapies (p < .001). CONCLUSIONS: A multifaceted intervention oriented at reducing therapeutic inertia by primary care physicians was associated with greater improvement in glycaemic control compared with patients treated as per usual care.

Impact of a multicomponent healthcare intervention on glycaemic control in subjects with poorly controlled type 2 diabetes: The INTEGRA study.

AIM: To evaluate whether a specially designed multicomponent healthcare intervention improves glycaemic control in subjects with poorly controlled type 2 diabetes. MATERIALS AND METHODS: A cluster, non-randomized, controlled, pragmatic trial in subjects from 11 primary care centres with type 2 diabetes and HbA1c of more than 9% (> 75 mmol/mol) was conducted. The intervention (N = 225 subjects) was professional and patient-centred, including a dedicated monographic visit that encouraged therapeutic intensification by physicians. The sham control (N = 181) was identical to that of the intervention group except that the dedicated visit was omitted. The primary outcome was to compare the reductions in HbA1c values between the groups at 12 months of follow-up. RESULTS: The mean age at baseline was 59.5 years, mean diabetes duration was 10.7 years and mean HbA1c was 10.3% (89.0 mmol/mol). Patients in the intervention arm achieved significantly greater HbA1c reduction than those in the sham control group at 12 months (mean difference -0.62%, 95% CI = -0.2%, -1.04%; P = .002). A larger percentage of intervention participants achieved an HbA1c of less than 8% (44.8% vs. 25.5%; P = .003) and were more frequently treated with more than three antidiabetic therapies (14.4% vs. 3.5%; P = .0008). Intervention was the only variable associated with higher odds of HbA1c less than 8% (odds ratio = 2.52; 95% CI = 1.54-4.12; P < .001). CONCLUSIONS: A multicomponent intervention including a dedicated visit oriented at reducing therapeutic inertia by primary care physicians can improve glycaemic control in poorly controlled patients with type 2 diabetes.

All-cause and cardiorenal mortality in 6 million adults with and without type 2 diabetes: A comparative, trend analysis in Canada, Spain, and the UK.

AIMS: To understand geographical and temporal patterns in the diabetes gap, the excess mortality risk associated with type 2 diabetes (T2D), in three high-income countries. METHODS: Using databases from Canada (Ontario), Spain (Catalonia) and the UK (England), we harmonized the study design and the analytical strategy to extract information on subjects aged over 35 years with incident T2D between 1998 and 2018 matched to up to five subjects without diabetes. We used Poisson models to estimate age-specific mortality trends by diabetes status and rate ratios and rate differences associated with T2D. RESULTS: In more than 6 million people, 694 454 deaths occurred during a follow-up of 52 million person-years. Trends in all-cause mortality rates differed between Ontario and England; yet, the diabetes gaps were very similar in recent years: in 2018, we estimated 1.3 (95% confidence interval: 0.8, 1.8) and 0.8 (0.2, 1.5) more deaths per 1000 person-years in 50-year-old men with diabetes in Ontario and England, respectively, and 8.9 (6.1, 11.7) and 12.1 (9.1, 15.1) in 80-year-old men; between-country differences were small also in women. In Catalonia, rate ratios comparing T2D with no diabetes in men in 2018 were 1.53 (1.11, 2.11) at 50 years old, 0.88 (0.72, 1.06) at 60 years old, 0.74 (0.60, 0.90) at 70 years old and 0.81 (0.66, 1.00) at 80 years old, indicating lower mortality rates in men with T2D from the age of 60 years; rates were similar in women with and without diabetes at all ages. The diabetes gaps in cardiorenal mortality mirrored those of all-cause mortality: we observed consistent reductions in the proportions of cardiorenal deaths in subjects aged 80 years but variations in subjects aged ≤70 years, regardless of the presence of diabetes. CONCLUSIONS: By reducing the confounding impact of epidemiological and analytical differences, this study showed geographical similarities and differences in the diabetes gap: an excess risk of all-cause and cardiorenal mortality in subjects with T2D is still present in Ontario and England in recent years, particularly in elderly subjects. Conversely, there were very small gaps in young men with T2D or even lower mortality rates in older subjects with T2D in Catalonia.

Mortality trends in type 1 diabetes: a multicountry analysis of six population-based cohorts.

AIMS/HYPOTHESIS: Mortality has declined in people with type 1 diabetes in recent decades. We examined how the pattern of decline differs by country, age and sex, and how mortality trends in type 1 diabetes relate to trends in general population mortality. METHODS: We assembled aggregate data on all-cause mortality during the period 2000-2016 in people with type 1 diabetes aged 0-79 years from Australia, Denmark, Latvia, Scotland, Spain (Catalonia) and the USA (Kaiser Permanente Northwest). Data were obtained from administrative sources, health insurance records and registries. All-cause mortality rates in people with type 1 diabetes, and standardised mortality ratios (SMRs) comparing type 1 diabetes with the non-diabetic population, were modelled using Poisson regression, with age and calendar time as quantitative variables, describing the effects using restricted cubic splines with six knots for age and calendar time. Mortality rates were standardised to the age distribution of the aggregate population with type 1 diabetes. RESULTS: All six data sources showed a decline in age- and sex-standardised all-cause mortality rates in people with type 1 diabetes from 2000 to 2016 (or a subset thereof), with annual changes in mortality rates ranging from -2.1% (95% CI -2.8%, -1.3%) to -5.8% (95% CI -6.5%, -5.1%). All-cause mortality was higher for male individuals and for older individuals, but the rate of decline in mortality was generally unaffected by sex or age. SMR was higher in female individuals than male individuals, and appeared to peak at ages 40-70 years. SMR declined over time in Denmark, Scotland and Spain, while remaining stable in the other three data sources. CONCLUSIONS/INTERPRETATION: All-cause mortality in people with type 1 diabetes has declined in recent years in most included populations, but improvements in mortality relative to the non-diabetic population are less consistent.

Mediterranean diet and diabetes risk in a cohort study of individuals with prediabetes: propensity score analyses.

AIMS: Randomized controlled trials have demonstrated the efficacy of several dietary patterns plus physical activity to reduce diabetes onset in people with prediabetes. However, there is no evidence on the effect from the Mediterranean diet on the progression from prediabetes to diabetes. We aimed to evaluate the effect from high adherence to Mediterranean diet on the risk of diabetes in individuals with prediabetes. METHODS: Prospective cohort study in Spanish Primary Care setting. A total of 1184 participants with prediabetes based on levels of fasting plasma glucose and/or glycated hemoglobin were followed up for a mean of 4.2 years. A total of 210 participants developed diabetes type 2 during the follow up. Hazard ratios of diabetes onset were estimated by Cox proportional regression models associated to high versus low/medium adherence to Mediterranean diet. Different propensity score methods were used to control for potential confounders. RESULTS: Incidence rate of diabetes in participants with high versus low/medium adherence to Mediterranean diet was 2.9 versus 4.8 per 100 persons-years. The hazard ratios adjusted for propensity score and by inverse probability weighting (IPW) had identical magnitude: 0.63 (95% confidence interval, 0.43-0.93). The hazard ratio in the adjusted model using propensity score matching 1:2 was 0.56 (95% confidence interval, 0.37-0.84). CONCLUSIONS: These propensity score analyses suggest that high adherence to Mediterranean diet reduces diabetes risk in people with prediabetes.

Cardiovascular and mortality benefits of sodium-glucose co-transporter-2 inhibitors in patients with type 2 diabetes mellitus: CVD-Real Catalonia.

BACKGROUND: Evidence from prospective cardiovascular (CV) outcome trials in type 2 diabetes (T2DM) patients supports the use of sodium-glucose co-transporter-2 inhibitors (SGLT2i) to reduce the risk of CV events. In this study, we compared the risk of several CV outcomes between new users of SGLT2i and other glucose-lowering drugs (oGLDs) in Catalonia, Spain. METHODS: CVD-REAL Catalonia was a retrospective cohort study using real-world data routinely collected between 2013 and 2016. The cohorts of new users of SGLT2i and oGLDs were matched by propensity score on a 1:1 ratio. We compared the incidence rates and hazard ratio (HR) for all-cause death, hospitalization for heart failure, chronic kidney disease, and modified major adverse CV event (MACE; all-cause mortality, myocardial infarction, or stroke). RESULTS: After propensity score matching, 12,917 new users were included in each group. About 27% of users had a previous history of CV disease. In the SGLT2i group, the exposure time was 60% for dapagliflozin, 26% for empagliflozin and 14% for canagliflozin. The use of SGLT2i was associated with a lower risk of heart failure (HR: 0.59; 95% confidence interval [CI] 0.47-0.74; p < 0.001), all-cause death (HR = 0.41; 95% CI 0.31-0.54; p < 0.001), all-cause death or heart failure (HR = 0.55; 95% CI 0.47-0.63; p < 0.001), modified MACE (HR = 0.62; 95% CI 0.52-0.74; p < 0.001), and chronic kidney disease (HR = 0.66; 95% CI 0.54-0.80; p < 0.001). CONCLUSIONS: In this large, retrospective observational study of patients with T2DM from a Catalonia, initiation of SGLT-2i was associated with lower risk of mortality, as well as heart failure and CKD.

Therapeutic Inertia: Still a Long Way to Go That Cannot Be Postponed.

In the context of type 2 diabetes, the definition of therapeutic inertia should include the failure not only to intensify therapy, but also to deintensify treatment when appropriate and should be distinguished from appropriate inaction in cases justified by particular circumstances. Therapy should be intensified when glycemic control deteriorates to prevent long periods of hyperglycemia, which increase the risk of complications. Strategic plans to overcome therapeutic inertia must include actions focused on patients, prescribers, health systems, and payers. Therapeutic inertia affects the management of glycemia, hypertension, and lipid disorders, all of which increase the risk for cardiovascular diseases. Thus, multifactorial interventions that act on additional therapeutic goals beyond glycemia are needed.

Glycaemic control after treatment intensification in patients with type 2 diabetes uncontrolled on two or more non-insulin antidiabetic drugs in a real-world setting.

AIM: To assess glycaemic control after treatment intensification in patients with type 2 diabetes uncontrolled on ≥2 non-insulin antidiabetic drugs (NIADS). METHODS: A retrospective cohort study, using electronic health records from the SIDIAP database (2010-2014), was conducted. Intensification was defined as the prescription of any new antidiabetic drug in patients treated with ≥2 NIADS and HbA1c >7%. The primary outcome was the absolute change in HbA1c 6-12 months after any intensification. Secondary analyses included the percentage of patients reaching HbA1c <7%, HbA1c <8%, and a reduction of HbA1c >1% after the first intensification. RESULTS: There were 21 241 intensifications in 15 205 patients with a mean (SD) HbA1c of 9.02% (±1.35). Insulin and dipeptidyl peptidase-4 inhibitors (DPP4i) were the most frequently added therapies. The mean baseline-adjusted HbA1c reduction was 0.78% (95% CI, -0.80 to -0.76), varying from -0.69% with DPP4i to -0.85% with glucagon-like peptide-1 receptor agonists while the addition of insulin was associated with a reduction >1%. After the first intensification, 48.9% of patients achieved HbA1c <8%, 16.2% HbA1c <7%, and 43.1% a reduction >1%. High previous HbA1c was positively associated with the reduction of HbA1c >1% [odds ratio (OR) 2.13 (95% CI: 2.05-2.21)], but inversely associated with the attainment of HbA1c <7% [OR 0.64 (0.61-0.67)] or < 8% [OR 0.63 (0.60-0.65)]. Older age, male gender, higher Charlson index, and short diabetes duration were associated with achievement of HbA1c <7%. CONCLUSIONS: Despite intensification, most patients failed the glycaemic goal of HbA1c <7%. The reduction depended mainly on preintensification HbA1c values, with small differences between drugs.

Therapeutic inertia in patients treated with two or more antidiabetics in primary care: Factors predicting intensification of treatment.

AIMS: To determine the patterns and predictors of treatment intensification in patients with type 2 diabetes on ≥2 non-insulin antidiabetic drugs (NIADs) and inadequate glycaemic control in primary care in Catalonia, Spain. MATERIAL AND METHODS: This was a retrospective analysis using electronic medical records from patients with HbA1c ≥ 7% and a first prescription for a new NIAD or insulin recorded from January 2010 to December 2014. Therapeutic inertia was defined as no intensification if HbA1c was ≥8% at baseline or during follow-up. Time to first intensification was evaluated by time-to-event analysis, and factors predicting intensification through a competing-risk regression model. RESULTS: Among 23 678 patients with HbA1c ≥ 7%, 26.2% were censored without treatment intensification after a median follow up of 4.2 years. Among the 12 730 patients in the subgroup with HbA1c ≥ 8% at baseline or during follow-up, therapeutic inertia was present in 18.1% of cases. In the overall cohort, mean HbA1c at initiation of insulin and NIAD were 9.4% ± 1.5% and 8.7% ± 1.3%, respectively. Median time to first intensification was 17.1 months in patients with HbA1c 8.0% to 9.9%, and 10.1 months in those with HbA1c > 10%. Variables strongly associated with intensification were HbA1c values 8.0% to 9.9% (subhazard ratio [SHR], 1.7; 95% CI, 1.65-1.78) and >10% (SHR, 2.5; 95% CI, 2.37-2.68); diabetes duration ≥20 years (SHR, 1.25; 95% CI, 1.11-1.41) and, to a lesser extent, female gender, presence of comorbidities, chronic kidney disease and microvascular complications. CONCLUSIONS: Intensification was not undertaken in 1 in 5 patients. Both HbA1c thresholds and time until therapy intensification exceeded current recommendations.

Impact of implementing electronic clinical practice guidelines for the diagnosis, control and treatment of cardiovascular risk factors: A pre-post controlled study.

OBJECTIVE: To evaluate the impact of computerized clinical practice guidelines on the management, diagnosis, treatment, control, and follow-up of the main cardiovascular risk factors: hypertension, hypercholesterolaemia, and type 2 diabetes mellitus. DESIGN: Pre-post controlled study. SETTING: Catalonia, autonomous community located in north-eastern Spain. PARTICIPANTS: Individuals aged 35-74 years assigned to general practitioners of the Catalan Health Institute. INTERVENTION: The intervention group consisted of individuals whose general practitioners had accessed the computerized clinical practice guidelines at least twice a day, while the control group consisted of individuals whose general practitioner had never accessed the computerized clinical practice guidelines platform. MAIN OUTCOMES: The Chi-squared test was used to detect significant differences in the follow-up, control, and treatment variables for all three disorders (hypertension, hypercholesterolaemia, and type 2 diabetes mellitus) between individuals assigned to users and non-users of the computerized clinical practice guidelines, respectively. RESULTS: A total of 189,067 patients were included in this study, with a mean age of 56 years (standard deviation 12), and 55.5% of whom were women. Significant differences were observed in hypertension management, treatment and control; type 2 diabetes mellitus management, treatment and diagnoses, and the management and control of hypercholesterolaemia in both sexes. CONCLUSIONS: Computerized clinical practice guidelines are an effective tool for the control and follow-up of patients diagnosed with hypertension, type 2 diabetes mellitus, and hypercholesterolaemia. The usefulness of computerized clinical practice guidelines to diagnose and adequately treat individuals with these disorders remains unclear.

[Adherence of Type 2 Diabetes Mellitus approach: Current situation and possible solutions]. / Abordaje de la adherencia en diabetes mellitus tipo2: situación actual y propuesta de posibles soluciones.

OBJECTIVES: Define the impact and causes of non-adherent type-2 diabetes mellitus (DM2) patients, possible solutions and the role of the different health care professionals involved in the treatment. DESIGN: Structured questionnaire rating by a two-round Delphi method. LOCATION: The study was conducted in the Primary Care settings. PARTICIPANTS: The expert panel consisted of renowned medical professionals with extensive experience in diabetes. MAIN MEASUREMENTS: Assessment through a 9-point Likert scale, of the degree of agreement or disagreement on 131 items grouped into 4 blocks: impact; causes of nonadherence; diagnosis of non-adherence, and possible causes, solutions and role of the different professionals involved in adherence. RESULTS: The participation rate was 76.31%. The primary care health professionals agreed on 110 of the 131 proposals statements (84%), showing agreement on 102 items (77.9%) and disagreement in 8 (6.1%). Consensus was not reached on 21 items. CONCLUSIONS: The lack of adherence of DM2 patients makes the achievement of therapeutic control difficult. The medical practice needs to have specific training and enough resources to reduce the impact of the lack of therapeutic compliance.

Metabolic control and cardiovascular risk factors in type 2 diabetes mellitus patients according to diabetes duration.

BACKGROUND: Control of glycaemic levels as well as cardiovascular risk factors (CVRF) is essential to prevent the onset of complications associated with type 2 diabetes mellitus (T2DM). AIM: To describe the degree of glycaemic control and CVRF in relation to diabetes duration. PATIENTS AND METHODS: Multicentre cross-sectional study in T2DM patients seen in primary care centres during 2007. VARIABLES: Demographical and clinical characteristics, antidiabetic treatments and development of disease complications. Diabetes duration classification: 0-5, 6-10, 11-20 and >20 years. Logistic regression models were used in the analysis. RESULTS: A total of 3130 patients; 51.5% males; mean age: 68±11.7 years; mean diabetes duration:7.0 (±5.6) years, median: 5 (interquartile range:3-9) years; mean HbA1c: 6.84 (±1.5), were analyzed. There has been a progressive decline in HbA1c levels (HbA1c > 7% in 25.8% of patients during the first 5 years and 51.8% after 20 years). Blood pressure values remained relatively stable throughout disease duration. The mean value of low density lipoprotein (LDL) experienced a slight decline with the progression of the disease, but due to the significant increase of cardiovascular disease (CVD) after 20 years of duration, less patients reached the recommended target (LDL < 100mg/dl) in secondary prevention. Logistic regression model controlling for age, sex and CVD showed that diabetes duration was related to glycaemic control (odds ratio: 1.066, 95% confidence interval: 1.050-1.082 per year) but not to blood pressure or LDL control. CONCLUSIONS: The degree of glycaemic control and the risk factors in relation to the duration of T2DM followed different patterns. Diabetes duration was associated with a poorer glycaemic control but in general had a limited role in blood pressure control or lipid profile.

Sex and age significantly modulate cardiovascular disease presentation in type 2 diabetes: a large population-based cohort study.

Aims: We aimed to describe and compare the incidence of the first cardiovascular event and its major subtypes, coronary heart disease (CHD), cerebrovascular disease, heart failure (HF), or peripheral artery disease (PAD), according to age and sex in a population-based cohort of individuals with type 2 diabetes (T2D) from a Mediterranean region. Material and methods: We used linked primary care electronic medical reports, pharmacy-invoicing data, and hospital admission disease registry records from the SIDIAP database, which contains linked data for 74% of the Catalonian population. We selected individuals with T2D aged 30 to 89 years free of cardiovascular disease (CVD). The primary outcome was the first presentation of CVD. Results: The study cohort included 247,751 individuals (48.6% women, 66.8 ± 11.9 years). During a 6.99-year follow-up, the cumulative incidence of the first cardiovascular event was 23.4%. Men were at higher risk for CVD (hazard ratio [HR]: 1.47 95%CI: 1.45-1.50), CHD (HR: 1.52 95%CI: 1.47-1.57), cerebrovascular disease (HR:1.07 95%CI: 1.03-1.10) and PAD (HR: 2.30 95%CI: 2.21-2.39) than women but at a lower risk for HF (HR:0.70 95%CI: 0.68-0.73). CHD and PAD were the most frequent CVD presentations among men (28.1% and 27.5%) and HF (40.1%) in women. CHD predominated among young participants of both sexes, while HF predominated among women older than 65 and men older than 75. Conclusions: In individuals with T2D, the overall risk and the type of first CVD manifestation largely varied by sex and age. This epidemiological evidence should be considered in clinical practice.

Effectiveness of a multicomponent healthcare intervention on blood pressure and lipids among subjects with poorly controlled type 2 diabetes: Findings from the INTEGRA study.

AIM: We aimed to evaluate the impact of a multicomponent healthcare intervention, primarily designed to improve glycemic control, on blood pressure and lipids in individuals with poorly controlled type 2 diabetes mellitus (T2DM) in the Catalonian primary care setting METHODS: A cluster, non-randomized, controlled pragmatic trial was conducted across 11 primary care centers. The intervention group (N=225) received a comprehensive, patient-centered approach, including a dedicated monographic consultation to address therapeutic inertia. The control group (N=181) mirrored the intervention group but lacked the monographic consultation. Secondary endpoints included lipid and blood pressure control assessed at baseline and after a 12-month follow-up. RESULTS: 245 participants completed the study over 12 months. We found no differences in the reduction of lipid laboratory parameters between the groups at the final visit. However, no significant differences were found between the groups for other lipids or the proportion of participants achieving lipid target values. Likewise, no differences were noted between the groups for blood pressure, its target control, and treatment at the final visit. Various clinical factors such as age, sex, diabetes duration, HbA1c levels, BMI, and macrovascular complications among the participants were associated with achieving lipid and blood pressure targets at the final visit. CONCLUSION: The pragmatic multicomponent intervention proposed in the INTEGRA study, showed that including a component designed to reduce clinical inertia in the management of glycemia did not demonstrate benefits in improving lipids and blood pressure in patients with poorly controlled T2DM.

Outcome of COVID-19 infection in people with diabetes mellitus or obesity in the primary care setting in Catalonia, Spain: A retrospective cohort study of the initial three waves.

AIM: We estimate the incidence and risk factors for fatal and non-fatal events among the COVID-19 infected subjects based on the presence of obesity or diabetes during the initial three epidemiological waves in our region. METHODS: This was a retrospective cohort study. A primary care database was used to identify persons with COVID-19. We stratified for subjects who either had diabetes mellitus or obesity. The follow-up period for study events was up to 90 days from inclusion. RESULTS: In total, 1238,710 subjects were analysed. Subjects with diabetes mellitus or obesity were older and had a worse comorbidity profile compared with groups without these conditions. Fatal events were more frequent among people with diabetes and during the first wave. In the second and third waves, the number of study events decreased. Diabetes was a risk factor for fatal events in all models, while obesity was only in the model adjusted for age, sex, diabetes and COVID-19 waves. HIV, cancer, or autoimmune diseases were risk factors for mortality among subjects with COVID-19 in the fully-adjusted model. CONCLUSIONS: Diabetes was an independent risk factor for mortality among people with COVID-19. The number of fatal events decreased during the second and third waves in our region, both in those with diabetes or obesity.

Adherence to the therapeutic guidelines recommendations among the people with type 2 diabetes mellitus and obesity, frailty, or recent diagnosis, attended in primary health care centers in Spain: A cross-sectional study.

Introduction: Clinical practice guidelines are helpful for clinicians, and their proper implementation could improve the quality of care and management of participants with diabetes. This study aimed to evaluate the degree of adherence to the Clinical Practice Guidelines (CPG) recommendations among obese, frail, or recently diagnosed type 2 diabetes mellitus (T2DM) participants in primary care centers in Spain. Methods: We perform a cross-sectional study on a national level in two phases. In the first phase, study participants were recruited, and their clinical data were collected. In the second phase, data related to the participating physicians were collected. Results: In total, 882 participants from 240 physicians were analyzed. According to the study questionnaire, most participants from all three clinical groups had adequate adherence to the CPG. This percentage was highest among the recently diagnosed T2DM (91.6%) and lowest percent of frail T2DM persons (74.7%). The inadequate adherence to the guidelines was observed mainly among the obese and frail participants with T2DM from medical doctors with low CPG knowledge (3.4% and 3.5%, respectively). Regarding the patient's characteristics and degree of adherence to the guidelines, the participants with inadequate adherence were generally older, with higher BMI, poorer HbA1c control, and fewer visits with primary care physicians. Most (57%) primary care physicians had moderate CPG knowledge. In our multivariable logistic model, we did not observe statistically significant odds ratios for different characteristics related to the physicians/consultation and low CPG knowledge. Discussion: The results of our cross-sectional study observe adequate adherence to the clinical guidelines by the primary care physicians for the majority of the participants with obesity, frailty, or newly diagnosed with T2DM.

Severe hypertriglyceridemia prevalence at a primary care setting in Catalonia, Spain.

BACKGROUND: Hypertriglyceridemia (HTG) increases the risk of cardiovascular disease and pancreatitis, and its prevalence varies across populations. OBJECTIVE: To determine the prevalence of moderate-to-severe hypertriglyceridemia (msHTG, 500-879 mg/dl) and severe hypertriglyceridemia (sHTG, ≥ 880 mg/dl) in a primary care population in Catalonia, Spain, and to categorize them according to presence/absence of factors potentially causing HTG. METHODS: Retrospective analysis of clinical and laboratory data in SIDIAP (Information System for the Development of Primary Care Research) from 2010, 2013, 2016, and 2019. We considered medications with hypolipidemic effects and those potentially increasing TG levels. We developed logistic regression models adjusted by age and sex to calculate the probability of having ms/sHTG according to covariates of interest. RESULTS: In the study years, 36.2‒42.0% of the >3.5 million active primary care users had ≥1 TG determination. Prevalence for msHTG was 0.7% and for sHTG 0.2% among those with recorded TG. In 2019, 54.7% were female; median (IQR) age was 62.5 (49.4‒73.7) years. Prevalence was higher in 36‒50-year-old persons (1.3% msHTG, 0.4% sHTG) and men (1.1% msHTG, 0.3% sHTG). Most cases were associated with secondary and <20% with non-secondary causes, the latter being most prevalent in young patients. The secondary causes more strongly associated with msHTG/sHTG were obesity, uncontrolled diabetes mellitus (DM) and gamma-glutamyl transferase >100 U/L. CONCLUSION: The prevalence of msHTG was 0.7% and that of sHTG was 0.2% between 2010 and 2019 among individuals with recorded TG. msHTG/sHTG most often affected men around their fifties and people with obesity and uncontrolled DM. Most msHTG and sHTG cases were associated with the presence of secondary causes.

Prediction of outcomes in subjects with type 2 diabetes and diabetic foot ulcers in Catalonian primary care centers: a multicenter observational study.

BACKGROUND: Diabetic foot and lower limb complications are an important cause of morbidity and mortality among persons with diabetes mellitus. Very few studies have been carried out in the primary care settings. The main objective was to assess the prognosis of diabetic foot ulcer (DFU) in patients from primary care centers in Catalonia, Spain, during a 12-month follow-up period. METHODS: We included participants with type 2 diabetes and a new DFU between February 2018 and July 2019. We estimated the incidence of mortality, amputations, recurrence and healing of DFU during the follow-up period. A multivariable analysis was performed to assess the association of these outcomes and risk factors. RESULTS: During the follow-up period, 9.7% of participants died, 12.1% required amputation, 29.2% had a DFU recurrence, and 73.8% healed. Having a caregiver, ischemia or infection were associated with higher mortality risk (hazard ratio [HR]:3.63, 95% confidence interval [CI]:1.05; 12.61, HR: 6.41, 95%CI: 2.25; 18.30, HR: 3.06, 95%CI: 1.05; 8.94, respectively). Diabetic retinopathy was an independent risk factor for amputation events (HR: 3.39, 95%CI: 1.37; 8.39). Increasing age decreased the risk for a DFU recurrence, while having a caregiver increased the risk for this event (HR: 0.97, 95%CI: 0.94; 0.99). The need for a caregiver and infection decreased the probability of DFU healing (HR: 0.57, 95%CI: 0.39; 0.83, HR: 0.64, 95%CI: 0.42; 0.98, respectively). High scores for PEDIS (≥7) or SINBAD (≥3) were associated with an increased risk for DFU recurrence and a lower probability of DFU healing, respectively. CONCLUSIONS: We observed high morbidity among subjects with a new DFU in our primary healthcare facilities. Peripheral arterial disease, infection, and microvascular complications increased the risk of poor clinical outcomes among subjects with DFU.