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

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

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

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. 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. 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. 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

Predictors of NOAC versus VKA use for stroke prevention in patients with newly diagnosed atrial fibrillation: Results from GARFIELD-AF.

INTRODUCTION: A principal aim of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) was to document changes in treatment practice for patients with newly diagnosed atrial fibrillation during an era when non-vitamin K antagonist oral anticoagulants (NOACs) were becoming more widely adopted. In these analyses, the key factors which determined the choice between NOACs and vitamin K antagonists (VKAs) are explored. METHODS: Logistic least absolute shrinkage and selection operator regression determined predictors of NOAC and VKA use. Data were collected from 24,137 patients who were initiated on AC ± antiplatelet (AP) therapy (NOAC [51.4%] or VKA [48.6%]) between April 2013 and August 2016. RESULTS: The most significant predictors of AC therapy were country, enrolment year, care setting at diagnosis, AF type, concomitant AP, and kidney disease. Patients enrolled in emergency care or in the outpatient setting were more likely to receive a NOAC than those enrolled in hospital (OR 1.16 [95% CI: 1.04-1.30], OR: 1.15 [95% CI: 1.05-1.25], respectively). NOAC prescribing seemed to be favored in lower-risk groups, namely, patients with paroxysmal AF, normotensive patients, and those with moderate alcohol consumption, but also the elderly and patients with acute coronary syndrome. By contrast, VKAs were preferentially used in patients with permanent AF, moderate to severe kidney disease, heart failure, vascular disease, and diabetes and with concomitant AP. CONCLUSION: GARFIELD-AF data highlight marked heterogeneity in stroke prevention strategies globally. Physicians are adopting an individualized approach to stroke prevention where NOACs are favored in patients with a lower stroke risk but also in the elderly and patients with acute coronary syndrome

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

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

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

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. 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. 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. 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