Comorbid autoimmune diseases and burden of diabetes-related complications in patients with type 1 diabetes from a Mediterranean area

Autoimmunity; Glycemic control; Type 1 diabetes mellitus;Autoinmunidad; Control Glicémico; Diabetes mellitus tipo 1Autoimmunitat; Control glucèmic; Diabetis mellitus tipus 1Aim: To assess the prevalence of autoimmune diseases (AID) in patients with type 1 diabetes (T1D) and to evaluate whether the rate of diabetes-related complications differs depending on the presence of AID. Methods: Cross-sectional analysis of 13,570 T1D patients aged ≥ 18 years registered in the SIDIAP database. The association between AID and diabetes-related complications was assessed by multivariable logistic regression models. Results: The prevalence of AID was 18.3% with thyroid AID being the most common. Patients with T1D and AID were more often female and their current age, age of diabetes onset and diabetes duration were higher. Patients with only thyroid AID experienced a lower risk of peripheral artery disease (odds ratio [OR] = 0.51, 95%; confidence interval [CI] 0.31 to 0.81) and kidney disease (OR = 0.68, 95%; 95% CI 0.54 to 0.85), whereas patients with other AID had an increased risk of ischemic heart disease (OR = 1.48, 95%; 95% CI 1.04 to 2.06). Conclusions: The burden of diabetes-related complications in patients with T1D differs according to the type of additional AID. The presence of diabetes complications is lower in those with autoimmune thyroid disease while the presence of other AID is associated with higher rates of ischemic heart disease

Evaluation of clinical and antidiabetic treatment characteristics of different sub-groups of patients with type 2 diabetes : Data from a Mediterranean population database

Altres ajuts: Institut Universitari d'Investigació en Atenció Primària Jordi GolAltres ajuts: MSD Spain 4R16/062-1Aims: To describe the characteristics and antidiabetic treatment among type 2 diabetes patients according to the clinical conditions prioritized in the Spanish 2020 RedGDPS (Primary Care Diabetes Study Groups Network) therapeutic algorithm: obesity, older than 75 years, chronic kidney disease, cardiovascular disease, and heart failure. Methods: Retrospective, cross-sectional study. Clinical characteristics, the use of antidiabetic drugs and the KDIGO renal risk categories at 31.12.2016 were retrieved from the SIDIAP (Information System for Research in Primary Care) database (Catalonia, Spain). Results: From a total of 373,185 type 2 diabetes patients, 37% were older than 75 years, 45% obese, 33% had chronic kidney disease, 23.2% cardiovascular disease and 6.9% heart failure. Insulin was more frequently prescribed in chronic kidney disease, cardiovascular disease and heart failure whereas Sodium-Glucose cotransporter 2 inhibitors and Glucagon Like Peptide 1 receptor agonists were scarcely prescribed (2.6% and 1.4%, respectively). Among patients with severe renal failure, contraindicated drugs like metformin (16%) and sulfonylureas (6.1%) were still in use. The 2012 KDIGO renal risk categories distribution was: Low: 60.9%, Moderate: 21.6%, High: 9.8% and Very high: 7.7%. Conclusions: Almost 80% of our T2DM patients meet one of the five clinical conditions that should be considered for treatment individualization. Importantly, a relevant number of patients with severe renal failure were found to use contraindicated drugs

Trends in the Degree of Control and Treatment of Cardiovascular Risk Factors in People With Type 2 Diabetes in a Primary Care Setting in Catalonia During 2007-2018

Objective: To assess the trends in cardiovascular risk factor control and drug therapy from 2007 to 2018 in subjects with type 2 diabetes mellitus (T2DM). Materials and Methods: Cross-sectional analysis using yearly clinical data and treatment obtained from the SIDIAP database. Patients aged ≥18 years with a diagnosis of T2DM seen in primary care in Catalonia, Spain. Results: The number of T2DM patients increased from 299,855 in 2007 to 394,266 in 2018. We also found an increasing prevalence of cardiovascular disease, heart failure, and chronic kidney disease (from 18.4 to 24.4%, from 4.5 to 7.3%, and from 20.2 to 31.3%, respectively). The achievement of glycemic targets (HbA1c<7%) scarcely changed (54.9% to 55.9%). Major improvements were seen in blood pressure (≤140/90 mmHg: from 55% to 71.8%), and in lipid control (low-density lipoprotein cholesterol <100 mg/dl: 33.4% to 48.4%), especially in people with established cardiovascular disease (48.8 to 69.7%). Simultaneous achievement of all three targets improved from 12.5% to 20.1% in the overall population and from 24.5% to 32.2% in those with cardiovascular disease but plateaued after 2013. There was an increase in the percentage of patients treated with any antidiabetic drug (70.1% to 81.0%), especially metformin (47.7% to 67.7%), and DPP4i (0 to 22.6%). The use of SGLT-2 and GLP-1ra increased over the years, but remained very low in 2018 (5.5% and 2.1% of subjects, respectively). There were also relevant increases in the use of statins (38.0% to 49.2%), renin-angiotensin system (RAS) drugs (52.5% to 57.2%), and beta-blockers (14.3% to 22.7%). Conclusions: During the 2007-2018 period, relevant improvements in blood pressure and lipid control occurred, especially in people with cardiovascular disease. Despite the increase in the use of antidiabetic and cardiovascular drugs, the proportion of patients in which the three objectives were simultaneously achieved is still insufficient and plateaued after 2013. The use of antidiabetic drugs with demonstrated cardio renal benefits (SGLT-2 and GLP-1ra) increased over the years, but their use remained quite low

Comorbid autoimmune diseases and burden of diabetes-related complications in patients with type 1 diabetes from a Mediterranean area

AIM: To assess the prevalence of autoimmune diseases (AID) in patients with type 1 diabetes (T1D) and to evaluate whether the rate of diabetes-related complications differs depending on the presence of AID. METHODS: Cross-sectional analysis of 13,570 T1D patients aged ≥ 18 years registered in the SIDIAP database. The association between AID and diabetes-related complications was assessed by multivariable logistic regression models. RESULTS: The prevalence of AID was 18.3% with thyroid AID being the most common. Patients with T1D and AID were more often female and their current age, age of diabetes onset and diabetes duration were higher. Patients with only thyroid AID experienced a lower risk of peripheral artery disease (odds ratio [OR] = 0.51, 95%; confidence interval [CI] 0.31 to 0.81) and kidney disease (OR = 0.68, 95%; 95% CI 0.54 to 0.85), whereas patients with other AID had an increased risk of ischemic heart disease (OR = 1.48, 95%; 95% CI 1.04 to 2.06). CONCLUSIONS: The burden of diabetes-related complications in patients with T1D differs according to the type of additional AID. The presence of diabetes complications is lower in those with autoimmune thyroid disease while the presence of other AID is associated with higher rates of ischemic heart disease

Potential Risk of Overtreatment in Patients with Type 2 Diabetes Aged 75 Years or Older : Data from a Population Database in Catalonia, Spain

Altres ajuts: Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol); Merck Sharp & Dohme de España S.A.Aim: To assess the potential risk of overtreatment in patients with type 2 diabetes (T2DM) aged 75 years or older in primary care. Methods: Electronic health records retrieved from the SIDIAP database (Catalonia, Spain) in 2016. Variables: age, gender, body mass index, registered hypoglycemia, last HbA1c and glomerular filtration rates, and prescriptions for antidiabetic drugs. Potential overtreatment was defined as having HbA1c < 7% or HbA1c < 6.5% in older patients treated with insulin, sulfonylureas, or glinides. Results: From a total population of 138,374 T2DM patients aged 75 years or older, 123,515 had at least one HbA1c available. An HbA1c below 7.0% was present in 59.1% of patients, and below 6.5% in 37.7%. Overall, 23.0% of patients were treated with insulin, 17.8% with sulfonylureas, and 6.6% with glinides. Potential overtreatment (HbA1c < 7%) was suspected in 26.6% of patients treated with any high-risk drug, 47.8% with sulfonylureas, 43.5% with glinides, and 28.1% with insulin. Using the threshold of HbA1c < 6.5%, these figures were: 21.6%, 24.4%, 17.9%, and 12.3%, respectively. Conclusion: One in four older adults with T2DM treated with antidiabetic drugs associated with a high risk of hypoglycemia might be at risk of overtreatment. This risk is higher in those treated with sulfonylureas or glinides than with insulin

How Many Patients with Type 2 Diabetes Meet the Inclusion Criteria of the Cardiovascular Outcome Trials with SGLT2 Inhibitors? Estimations from a Population Database in a Mediterranean Area

Altres ajuts: This study was funded by the Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol). CIBER of Diabetes and Associated Metabolic Diseases (CIBERDEM) is an initiative from Instituto de Salud Carlos III, Madrid, Spain.Objective. Regulatory agencies require the assessment of cardiovascular (CV) safety for new type 2 diabetes (T2D) therapies through CV outcome trials (CVOTs). However, patients included in CVOTs assessing sodium-glucose cotransporter-2 inhibitors (SGLT2i) might not be representative of those seen in clinical practice. This study examined the proportion of patients that would have been enrolled into three main SGLT2i CVOTs to determine whether these trials' eligibility criteria can be applied to a real-world Mediterranean T2D population. Methods. Cross-sectional, retrospective, cohort study of T2D patients registered in primary care centres of the Catalan Institute of Health using medical records from a population database (SIDIAP) that includes approximately 74% of the population in Catalonia (Spain). Eligibility criteria were according to those of three SGLT2i CVOTs: EMPA-REG OUTCOME (empagliflozin), CANVAS (canagliflozin), and DECLARE-TIMI 58 (dapagliflozin). Results. By the end of 2016, the database included 373,185 patients with T2D with a mean age of 70±12 years, 54.9% male, with a mean duration of T2D of 9±6 years, and a mean glycated haemoglobin (HbA1c) of 7.12%±1.32 (59% with HbA1c<7%). Of these, 86,534 (23%) had established CV disease and 28% chronic renal failure (estimated glomerular filtration<60 ml/min/1.73m2). Among all included patients, only 8.2% would have qualified for enrolment into the EMPA-REG OUTCOME trial, 29.6% into the CANVAS program, and 38% into the DECLARE-TIMI 58 trial. The main limiting factors for inclusion would have been a previous history of CV disease and the baseline HbA1c value. Conclusion. The external validity of the analysed CVOTs is clearly limited when applying the same eligibility criteria to a T2D Mediterranean population

INTEGRA study protocol: primary care intervention in type 2 diabetes patients with poor glycaemic control

Background The management of hyperglycaemia and associated cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM) may reduce diabetes-related complications. The strategy to broaden the knowledge base of primary care professionals to improve health care has mainly been prompted by the current reality of limited resources and access to specialized care. The main objective of this study is to assess the effectiveness of comprehensive interventions focused on treatment intensification, decrease clinical inertia and reduce possible barriers to treatment adherence in patients with poorly controlled diabetes in a primary care setting. Methods This is a two-phase mixed method study, whose aims are the development of complex interventions and the assessment of their effectiveness. The main study outcome is a change in glycated haemoglobin (HbA1c) levels. The INTEGRA study is divided into two phases. Phase 1: A qualitative study with a phenomenological approach using semi-structured interviews with the objective of determining the factors related to the participants and health care professionals that influence the development and implementation of a specific intervention strategy aimed at patients with poor glycaemic control of T2DM in primary care. Phase 2: Exploratory intervention study to be conducted in Primary Health Care Centres in Catalonia (Spain), including 3 specific health care areas. The intervention study has two arms: Intervention Group 1 and 2. Each intervention group will recruit 216 participants (the same as in the control group) between the ages of 30 and 80 years with deficient glycaemic control (HbA1c > 9%). The control group will be established based on a randomized selection from the large SIDIAP (Sistema d’Informació per al desenvolupament de la Investigació en Atenció Primària) database of patients with comparable socio-demographic and clinical characteristics from the three provinces. Discussion This study is a comprehensive, pragmatic intervention based on glycaemic treatment intensification and the control of other cardiovascular risk factors. It is also aimed at improving treatment adherence and reducing clinical inertia, which could lead to improved glycaemic control and could likewise be feasible for implementation in the actual clinical practice of primary care.The study is partially supported by unrestricted grant from Sanofi. The study has also intramural support from Institut Universitari d’Investigació en Atenció Primària Jordi Gol. The funder does not have any role in writing the study protocol. This funding source will not have any role during its execution, analyses, interpretation of the data, or decision to submit results

Analysis of the Adherence and Safety of Second Oral Glucose-Lowering Therapy in Routine Practice From the Mediterranean Area : A Retrospective Cohort Study

Altres ajuts: AstraZeneca/ESR-16-12628Altres ajuts: Applied Research Collaboration East Midlands (ARC EM)Altres ajuts: National Institute for Health Research (NIHR)Altres ajuts: Imperial Biomedical Research Centre (NIHR)The aims of our study was compare adherence measured by the medical possession ratio (MPR), time until discontinuation and describe adverse events after adding a DPP-4i, SGLT-2i, or sulfonylureas (SU) to metformin in a primary care population with insufficient glycemic control. We used routinely-collected health data from the SIDIAP database. The included subjects were matched by propensity score. The follow-up period was up to 24 months or premature discontinuation. The primary outcomes were the percentage of subjects with good adherence, treatment discontinuation and adverse events among treatment groups. The proportion of patients with good adherence (MPR> 0.8) after the addition of DPP-4i, SGLT-2i or SU was 53.6%, 68.7%, and 43.0%, respectively. SGLT-2i users were 1.7 times more likely to achieve good adherence compared with DPP-4i users (odds ratio [OR]:1.72, 98% confidence interval [CI]:1.51, 1.96), and 2.8 times more likely compared with SU users (OR: 0.35, 98% CI: 0.07, 0.29). The discontinuation hazard ratios were 1.43 (98%CI: 1.26; 1.62) and 1.60 (98%CI: 1.42; 1.81) times higher among SGLT-2i and SU users than DPP-4i users during the follow-up period. No differences were observed for adverse events among the treatment groups. In conclusion, in our real-world setting, the combination of SGLT-2i with metformin was associated with better adherence. The mean time until discontinuation was longer in the SGLT-2i group in comparison with the DPP-4i or SU groups

Prevalence and risk factors of diabetic foot disease among the people with type 2 diabetes using real-world practice data from Catalonia during 2018

Altres ajuts: 8a Convocatòria d'Ajuts a projectes de Institut Català de la Salut with SIDIAP (financing code 4R18/187-1 and file number SIDIAP-18/7).Background: Our study aimed to assess the prevalence of diabetic foot disease (DFD) and its associated risk factors among subjects attending primary care centers in Catalonia (Spain). Methods: We undertook a cross-sectional analysis of data from the primary health care (SIDIAP) database. The presence of comorbidities and concomitant medication were analyzed for subjects with or without DFD. DFD prevalence was estimated from 1st January 2018 to 31st December 2018. Results: During the 12-month observational period, out of 394,266 people with type 2 diabetes, we identified 3,277 (0.83%) active episodes of DFD in the database. The majority of these episodes were foot ulcers (82%). The mean age of patients with DFD was 70.3 (± 12.5) years and 55% were male. In the multivariable descriptive models, male gender, diabetes duration, hypertension, macrovascular, microvascular complications, and insulin and antiplatelet agents were strongly associated with DFD. A previous history of DFD was the stronger risk factor for DFD occurrence in subjects with T2DM (OR: 13.19, 95%CI: 11.81; 14.72). Conclusions: In this real-world primary care practice database, we found a lower prevalence of DFD compared to similar previous studies. Risk factors such as male sex, duration of diabetes, diabetes complications and previous history of DFD were associated with the presence of DFD

Obesity and related comorbidities in a large population-based cohort of subjects with type 1 diabetes in Catalonia

Obesity; Type 1 diabetes; Cardiovascular risk factorsObesidad; Diabetes tipo 1; Factores de riesgo cardiovascularObesitat; Diabetis tipus 1; Factors de risc cardiovascularIntroduction: Obesity, an increasing global health problem, can affect people with other disease conditions. The prevalence of obesity in people with type 1 diabetes (T1D) is not well known. The aim of this study was to describe extensively the characteristics and prevalence of different classes of obesity according to BMI (body mass index) categories in a large cohort of patients with T1D. Material and methods: This was a retrospective, cross-sectional study in Catalonia. We reviewed all patients with T1D diagnosis, ≥ 18 years old and with BMI data from the SIDIAP database. Sociodemographic and clinical data, cardiovascular risk factors, laboratory parameters and concomitant medications were collected. Results: A total of 6,068 patients with T1D were analyzed. The prevalence of obesity in the total sample was 18% (13.8% with class 1 obesity [BMI 30-34.9 kg/m2]). Patients with obesity had a higher prevalence of other cardiovascular risk factors (i.e. hypertension was 61.4% vs. 37.5%; dyslipidemia 63.6% vs 44%, and chronic kidney disease 38.4% vs. 24.4%; p 25 kg/m2. Patients with obesity did not have poorer glycemic control. Conclusion: The presence of obesity in people with T1D is frequent and cardiovascular risk factors are more common and more poorly controlled in T1D patients with obesity