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Anna Berenguera,1,2,* Àngels Molló-Inesta,1,3,4,* Manel Mata-Cases,1,4–6 Josep Franch-Nadal,1,2,6–8 Bonaventura Bolíbar,1 Esther Rubinat,1,9,10 Dídac Mauricio1,11 1Scientific Department, Institut Universitari d’Investigació en Atenció Primària Jordi Gol, Cerdanyola del Vallès, Spain; 2Primary Care Department, Universitat Autònoma de Barcelona, Barcelona, Spain; 3Cervera Primary Health Care Centre, Ileida, Spain; 4Diabetes Association in Primary Health Care (RedGDPS), Institut Català de la Salut, Barcelona, Spain; 5La Mina Primary Health Care Centre, Barcelona, Spain; 6CIBER of Diabetes and Associated Metabolic Diseases (CIBERDEM), Barcelona, Spain; 7Raval Sud Primary Health Care Centre, Barcelona, Spain; 8Primary Health Care Department, Institut Català de la Salut, Barcelona, Spain; 9Nursery Department, Univeristat de Lleida, Lleida, Spain; 10Centro de Investigacion Biomedica en Red de Diabetes y Enfermedades Metabolicas Asociadas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), Barcelona, Spain; 11Endocrinology & Nutrition Department, CIBER of Diabetes and Associated Metabolic Diseases (CIBERDEM), Health Sciences Research Institute and Hospital Germans Trias i Pujol, Badalona, Spain *These authors contributed equally to this work Purpose: The purpose of this study was to identify the perceptions, barriers, and facilitators of self-management of Type 2 diabetes mellitus (T2DM) to determine the factors to consider when developing and implementing a person-centered intervention in patients with poor glycemic control attending primary care. Methods: This was a qualitative study conducted in 6 primary care health centers in Catalonia. Patients who had been diagnosed with T2DM and had glycated hemoglobin of 9% or more were included. The sampling method was opportunistic, accounting for gender, age, duration of diabetes, and type of treatment. Forty-three semi-structured interviews were conducted. Thematic content analysis was performed. Results: The patients perceived the diagnosis of T2DM as a threat to their health, and the diagnosis generated cognitive and emotional representations of T2DM. The emotions associated with the diagnosis included fear of the future, worry, denial, sadness, and dejection. The patients also wondered if there could have been an error in their test results because they did not present any symptoms. These representations, both cognitive and emotional, can produce specific effects in adaptation processes and require different approach strategies, specifically regarding diet, physical activity, and pharmacological treatment. Finally, specific aspects regarding the acceptability and adaptability of the implementation of a new intervention were expressed. Conclusion: Patients with T2DM and very poor glycemic control expressed difficulty achieving a balance between the needs and demands of managing and controlling T2DM because they felt it strongly interfered in their daily lives. Keywords: qualitative research, interviews as a topic, Type 2 diabetes, self-management

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., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The funders had no role in the design of the study, in the collection, analysis, or interpretation of data, in the writing of the manuscript, or in the decision to publish the results. M.M.-C. has received advisory and or speaking fees from Astra-Zeneca, Bayer, Boehringer Ingelheim, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi; he has received research grants to the institution from Astra-Zeneca, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi. J. F.-N. has received advisory and or speaking fees from Astra-Zeneca, Ascensia, Boehringer Ingelheim, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi; he has received research grants to the in-stitution from Astra-Zeneca, GSK, Lilly, MSD, Novartis, Novo Nordisk, Sanofi, and Boehringer. D.M. has received advisory and/or speaking fees from AB Biotics, Amgen, Almirall, Ferrer, Gilead, Menarini, MSD, Novo Nordisk and Sanofi. A.M has received advisory and or speaking fees from Astra-Zeneca, Boehringer Ingelheim, Lilly, MSD, Novo Nordisk, and Sanofi; he has received research grants to the institution from Sanofi. M.G, A.B., E.R. and B.V. have no conflict of interest to declare., (Copyright © 2024 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.)

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., (© 2023 John Wiley & Sons Ltd.)

Background: People with diabetes mellitus are at increased risk of postoperative complications. Data from randomised clinical trials and meta-analyses point to a potential benefit of intensive glycaemic control, targeting near-normal blood glucose, in people with hyperglycaemia (with and without diabetes mellitus) being submitted for surgical procedures. However, there is limited evidence concerning this question in people with diabetes mellitus undergoing surgery., Objectives: To assess the effects of perioperative glycaemic control for people with diabetes undergoing surgery., Search Methods: For this update, we searched the databases CENTRAL, MEDLINE, LILACS, WHO ICTRP and ClinicalTrials.gov. The date of last search for all databases was 25 July 2022. We applied no language restrictions., Selection Criteria: We included randomised controlled clinical trials (RCTs) that prespecified different targets of perioperative glycaemic control for participants with diabetes (intensive versus conventional or standard care)., Data Collection and Analysis: Two authors independently extracted data and assessed the risk of bias. Our primary outcomes were all-cause mortality, hypoglycaemic events and infectious complications. Secondary outcomes were cardiovascular events, renal failure, length of hospital and intensive care unit (ICU) stay, health-related quality of life, socioeconomic effects, weight gain and mean blood glucose during the intervention. We summarised studies using meta-analysis with a random-effects model and calculated the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes, using a 95% confidence interval (CI), or summarised outcomes with descriptive methods. We used the GRADE approach to evaluate the certainty of the evidence (CoE)., Main Results: A total of eight additional studies were added to the 12 included studies in the previous review leading to 20 RCTs included in this update. A total of 2670 participants were randomised, of which 1320 were allocated to the intensive treatment group and 1350 to the comparison group. The duration of the intervention varied from during surgery to five days postoperative. No included trial had an overall low risk of bias. Intensive glycaemic control resulted in little or no difference in all-cause mortality compared to conventional glycaemic control (130/1263 (10.3%) and 117/1288 (9.1%) events, RR 1.08, 95% CI 0.88 to 1.33; I 2 = 0%; 2551 participants, 18 studies; high CoE). Hypoglycaemic events, both severe and non-severe, were mainly experienced in the intensive glycaemic control group. Intensive glycaemic control may slightly increase hypoglycaemic events compared to conventional glycaemic control (141/1184 (11.9%) and 41/1226 (3.3%) events, RR 3.36, 95% CI 1.69 to 6.67; I 2 = 64%; 2410 participants, 17 studies; low CoE), as well as those considered severe events (37/927 (4.0%) and 6/969 (0.6%), RR 4.73, 95% CI 2.12 to 10.55; I 2 = 0%; 1896 participants, 11 studies; low CoE). Intensive glycaemic control, compared to conventional glycaemic control, may result in little to no difference in the rate of infectious complications (160/1228 (13.0%) versus 224/1225 (18.2%) events, RR 0.75, 95% CI 0.55 to 1.04; P = 0.09; I 2 = 55%; 2453 participants, 18 studies; low CoE). Analysis of the predefined secondary outcomes revealed that intensive glycaemic control may result in a decrease in cardiovascular events compared to conventional glycaemic control (107/955 (11.2%) versus 125/978 (12.7%) events, RR 0.73, 95% CI 0.55 to 0.97; P = 0.03; I 2 = 44%; 1454 participants, 12 studies; low CoE). Further, intensive glycaemic control resulted in little or no difference in renal failure events compared to conventional glycaemic control (137/1029 (13.3%) and 158/1057 (14.9%), RR 0.92, 95% CI 0.69 to 1.22; P = 0.56; I 2 = 38%; 2086 participants, 14 studies; low CoE). We found little to no difference between intensive glycaemic control and conventional glycaemic control in length of ICU stay (MD -0.10 days, 95% CI -0.57 to 0.38; P = 0.69; I 2 = 69%; 1687 participants, 11 studies; low CoE), and length of hospital stay (MD -0.79 days, 95% CI -1.79 to 0.21; P = 0.12; I 2 = 77%; 1520 participants, 12 studies; very low CoE). Due to the differences within included studies, we did not pool data for the reduction of mean blood glucose. Intensive glycaemic control resulted in a mean lowering of blood glucose, ranging from 13.42 mg/dL to 91.30 mg/dL. One trial assessed health-related quality of life in 12/37 participants in the intensive glycaemic control group, and 13/44 participants in the conventional glycaemic control group; no important difference was shown in the measured physical health composite score of the short-form 12-item health survey (SF-12). One substudy reported a cost analysis of the population of an included study showing a higher total hospital cost in the conventional glycaemic control group, USD 42,052 (32,858 to 56,421) compared to the intensive glycaemic control group, USD 40,884 (31.216 to 49,992). It is important to point out that there is relevant heterogeneity between studies for several outcomes. We identified two ongoing trials. The results of these studies could add new information in future updates on this topic., Authors' Conclusions: High-certainty evidence indicates that perioperative intensive glycaemic control in people with diabetes undergoing surgery does not reduce all-cause mortality compared to conventional glycaemic control. There is low-certainty evidence that intensive glycaemic control may reduce the risk of cardiovascular events, but cause little to no difference to the risk of infectious complications after the intervention, while it may increase the risk of hypoglycaemia. There are no clear differences between the groups for the other outcomes. There are uncertainties among the intensive and conventional groups regarding the optimal glycaemic algorithm and target blood glucose concentrations. In addition, we found poor data on health-related quality of life, socio-economic effects and weight gain. It is also relevant to underline the heterogeneity among studies regarding clinical outcomes and methodological approaches. More studies are needed that consider these factors and provide a higher quality of evidence, especially for outcomes such as hypoglycaemia and infectious complications., (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

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., (© 2022 John Wiley & Sons Ltd.)

This was a prospective, observational study to compare the burden of subclinical atherosclerosis as measured by carotid ultrasonography in a cohort of subjects with prediabetes vs. subjects with normal glucose tolerance (NGT) from a non-urban Mediterranean population. Atherosclerosis was assessed through carotid intima-media thickness (c-IMT), the presence/absence of carotid plaques, and plaque number. Among 550 subjects included, 224 (40.7%) had prediabetes. The mean c-IMT and the prevalence of carotid plaque were significantly higher in the prediabetes group compared to the NGT group (0.72 vs. 0.67 mm, p < 0.001; and 37.9% vs. 19.6%; p < 0.001, respectively). Older age, male gender, and increased systolic blood pressure were positively correlated with c-IMT and were independent predictors of the presence of plaques. In contrast, prediabetes and low-density lipoprotein (LDL)-c were predictors of the presence of plaque (odds ratio [OR] = 1.64; 95% confidence interval [CI] = 1.05-2.57; p = 0.03 and OR = 1.01; 95% CI = 1.00-1.02; p = 0.006, respectively) together with tobacco exposure and the leukocyte count (OR = 1.77; 95% CI = 1.08-2.89; p = 0.023 and OR = 1.20; 95% CI = 1.05-1.38; p = 0.008, respectively). In a non-urban Mediterranean population, prediabetes was associated with established subclinical carotid atherosclerosis. These findings could have implications for the prevention and treatment of CV risk in these subjects before the first symptoms of cardiovascular disease appear.

The aim of this study was to assess the dietary pattern (i.e., Mediterranean Diet (MedDiet) and healthy eating) in people with type 2 diabetes (T2D) compared with those without diabetes. In addition, we explored clinical factors associated with the dietary pattern. This cross-sectional study was performed with a sample of 476 participants (238 with T2D and 238 participants without diabetes, matched for age and sex). The alternate Mediterranean Diet (aMED) score and the alternate Healthy Eating Index (aHEI) were calculated. Statistical analysis included comparison between groups and multivariable models. Participants with T2D showed higher aMED and aHEI scores (mean (SD): 4.3 (1.5) and 43.9 (6.5), respectively) in comparison with the control group (3.5 (1.8) and 39.4 (7.4), respectively; p < 0.001). In addition, a higher proportion of participants with T2D in higher tertiles of aMED (21.8%) and aHEI (39.9%) was observed compared with participants without diabetes (11.3% for the aMED, and 19.3% for the aHEI; p < 0.001). The adjusted multivariable analysis revealed that T2D ( p < 0.001), increasing age ( p = 0.006 and p = 0.030, respectively), and physical activity ( p = 0.009) were positively associated with higher aMED and aHEI scores. Dyslipidemia and female gender were positively associated with aMED and aHEI ( p = 0.031 and p < 0.001, respectively). The specific multivariable analysis for the group with T2D yielded a positive association of age ( p < 0.001) and dyslipidemia ( p = 0.021) with aMED. Regarding the aHEI, only female gender was positively related with this score in diabetes participants ( p = 0.025). Participants with T2D showed a higher adherence to the MedDiet and a healthier eating pattern.

Diabetic retinopathy (DR) may potentially cause vision loss and affect the patient's quality of life (QoL) and treatment satisfaction (TS). Using specific tools, we aimed to assess the impact of DR and clinical factors on the QoL and TS in patients with type 1 diabetes. This was a cross-sectional, two-centre study. A sample of 102 patients with DR and 140 non-DR patients were compared. The Audit of Diabetes-Dependent Quality of Life (ADDQoL-19) and Diabetes Treatment Satisfaction Questionnaire (DTSQ-s) were administered. Data analysis included bivariate and multivariable analysis. Patients with DR showed a poorer perception of present QoL ( p = 0.039), work life ( p = 0.037), dependence ( p = 0.010), and had a lower average weighted impact (AWI) score ( p = 0.045). The multivariable analysis showed that DR was associated with a lower present QoL ( p = 0.040), work life ( p = 0.036) and dependence ( p = 0.016). With regards to TS, DR was associated with a higher perceived frequency of hypoglycaemia ( p = 0.019). In patients with type 1 diabetes, the presence of DR is associated with a poorer perception of their QoL. With regard to TS, these subjects also show a higher perceived frequency of hypoglycaemia.

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., Trial Registration: Clinicaltrials.gov . registration number. NCT02663245; January 25, 2016.

Medical nutrition therapy is an important part of the management of type 1 diabetes mellitus (T1DM). Proper adherence to a healthy diet may have a favorable impact on diabetes management and its diabetic complications. Our aim was to assess differences in food and nutrient intake of type 1 diabetic patients with and without diabetic retinopathy (DR). This was a two-center, cross-sectional study in patients with T1DM, with and without DR. Subjects were recruited from the outpatient clinic of the two participating centers. A validated food frequency questionnaire was administered. A total of 103 T1DM patients with DR and 140 T1DM patient without DR were recruited. Subjects with DR showed a lower intake of total fat ( p = 0.036) than that of their non-DR counterparts. DR was associated with increasing age ( p = 0.004), hypertension ( p < 0.001), and diabetes duration ( p < 0.001), however there was a negative association with high educational level ( p = 0.018). The multivariate-adjusted analysis showed that the intake of complex carbohydrates was positively related to the presence of DR ( p = 0.031). In contrast, the intakes of total fat ( p = 0.009), monounsaturated fatty acids (MUFAs) ( p = 0.012), oleic acid ( p = 0.012), and vitamin E ( p = 0.006) were associated with the absence of DR. As conclusions, the intake of total MUFAs, oleic acid, and vitamin E is associated with a lower frequency of DR in patients with T1DM. These results suggest a potential protective effect of these lipid components for DR.

Background: Cardiovascular (CV) disease due to atherosclerosis is a major cause of morbidity and mortality in adult patients with diabetes, either type 1 or type 2 diabetes. The aim of the study was to assess the association of the frequency and the burden of subclinical carotid atherosclerotic disease in patients with type 1 diabetes according to the presence and severity of diabetic retinopathy (DR)., Methods: A cross-sectional study was conducted in 340 patients with type 1 diabetes (41.5% with DR), and in 304 non-diabetic individuals. All participants were free from previous CV disease and chronic kidney disease (CKD). B-mode carotid ultrasound imaging was performed in all the study subjects. Patients with type 1 diabetes underwent a full eye examination, and DR patients were divided into two groups: mild disease and advanced disease., Results: In the group of patients with type 1 diabetes, the percentage of patients with carotid plaques was higher in those with DR compared with those without DR (44.7% vs. 24.1%, p < 0.001). Patients with DR also presented a higher incidence of ≥ 2 carotid plaques (25.5% vs. 11.1%, p < 0.001). Apart from other traditional cardiovascular risk factors, the presence of advanced stages of DR was independently associated with the presence (p = 0.044) and the burden (≥ 2 carotid plaques; p = 0.009) of subclinical carotid atherosclerosis., Conclusions: In patients with type 1 diabetes without previous CV disease or established CKD, the presence of advanced stages of DR is associated with a higher atherosclerotic burden in the carotid arteries. The presence of DR identifies patients at risk for carotid atherosclerotic disease.

The author found errors in Table 1 after publication of the original article [1].

Background: LADA is probably the most prevalent form of autoimmune diabetes. Nevertheless, there are few data about cardiovascular disease in this group of patients. The aim of this study was to investigate the frequency of carotid atherosclerotic plaques in patients with LADA as compared with patients with classic type 1 diabetes and type 2 diabetes., Methods: Patients with LADA were matched for age and gender in different proportions to patients with type 2 diabetes, and classic type 1 diabetes. None of the patients had clinical cardiovascular disease. All subjects underwent B-mode carotid ultrasound to detect atheroma plaques. Demographics were obtained from all subjects., Results: We included 71 patients with LADA, 191 patients with type 2 diabetes and 116 patients with type 1 diabetes. Carotid atherosclerosis was more frequent in patients with LADA compared with type 2 diabetes (73.2% vs. 56.9%, P = 0.0018) and classic type 1 diabetes (57.1%, P = 0.026); these changes occurred despite healthier macrovascular risk profiles in the former. Age (P < 0.001), smoking (P = 0.003) and hypertension (P = 0.019) were independently associated with carotid atherosclerosis. Multiple plaques were also more frequent in patients with LADA as compared with classic type 1 diabetes and type 2 diabetes (45.1% and 33.6% vs. 27.2%, respectively, P = 0.022). The frequency of carotid plaques increased with increasing diabetes duration in LADA patients compared with type 2 diabetes (85.7% vs. 58.8%, inverse OR 5.72 [1.5-21.8]; P = 0.009)., Conclusions: LADA patients do not present with less carotid atherosclerosis than patients with type 1 and type 2 diabetes. Their macrovascular risk occurs despite a healthier macrovascular risk profile than those patients with type 2 diabetes.

Purpose: The Mollerussa prospective cohort was created to study pre-diabetes in a population-based sample from the primary care setting in the semirural area of Pla d'Urgell in Catalonia (Spain). The aims of the study were to assess the prevalence of pre-diabetes in our population, the likelihood to develop overt diabetes over time and to identify risk factors associated with the progression of the condition., Participants: The cohort includes 594 subjects randomly selected between March 2011 and July 2014 from our primary care population, who were older than 25 years, consented to participate and did not have a recorded diagnosis of diabetes., Findings to Date: At baseline, we performed a clinical interview to collect demographic, clinical and lifestyle (including a nutritional survey) characteristics; carotid ultrasound imaging to assess subclinical cardiovascular disease was also performed, and a blood sample was collected, with an overall <5% rate of missing data. An additional blood draw was performed 12 months after initial recruitment to reassess laboratory results in patients initially identified as having pre-diabetes, with an 89.6% retention rate. Several studies investigating various hypotheses are currently ongoing., Future Plans: All subjects recruited during the cohort creation will be followed long-term through annual extraction of data from health records stored in the electronic Clinical station in Primary Care database. The Mollerussa cohort will thus be a sound population-based sample for multiple future research projects to generate insights into the epidemiology and natural history of pre-diabetes in Spain., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Aims: To assess whether circulating 25-hydroxyvitamin D 3 (25OHD) and mineral metabolism-related factors (serum phosphate, calcium, and parathormone) are associated with subclinical carotid atherosclerosis (SCA), defined as the presence of carotid atherosclerotic plaques (main study outcome), in patients with type 2 diabetes mellitus (T2DM) without kidney disease or previous cardiovascular disease., Methods: We undertook a post hoc analysis of a cross-sectional study in adults with T2DM in whom we evaluated SCA. A total of 303 subjects with T2DM were included. Clinical variables and carotid ultrasound imaging were obtained., Results: We found no association of 25OHD with the presence of SCA. However, calcium phosphate (CaP; mg 2 /dL 2 ) product was positively associated with the presence of carotid plaques (OR adj  = 1.078; 95% CI: 1.017-1.142). An inverse association was observed between higher levels of 25OHD (≥30 ng/mL versus <20 ng/mL concentrations) and common carotid intima-media thickness (cIMT; mm) ( β adj  ± SE = -0.055 ± 0.024). We conclude that the CaP product is independently associated with the presence of established subclinical carotid atherosclerosis in patients with T2DM.

Objective: We sought to examine the presence and severity of brain small vessel disease (SVD) in patients with type 2 diabetes and diabetic retinopathy (DR) compared with those without DR., Research Design and Methods: We evaluated 312 patients with type 2 diabetes without previous cardiovascular disease (men 51%; mean age 57 years; age range 40-75 years); 153 patients (49%) had DR. MRI was performed to evaluate the presence and severity (age-related white matter changes scale) of white matter lesions (WMLs) and lacunes, and transcranial Doppler ultrasound was used to measure the Gosling pulsatility index (PI) of the middle cerebral artery (MCA)., Results: The prevalence of lesions of cerebral SVD (WML and/or lacunes) was higher in patients with DR (40.2% vs. 30.1% without DR, P = 0.04). Age (P < 0.01) and systolic blood pressure (P = 0.02) were associated with the presence of SVD. The severity of SVD was associated with age and the presence of DR (P < 0.01 and P = 0.01, respectively). Patients with DR showed a higher MCA PI compared with those without DR (P < 0.01). Age, systolic and diastolic blood pressure, and retinopathy and its severity were associated with an increased MCA PI (P < 0.01 for all variables). A positive correlation was found between MCA PI values and the presence and severity of SVD (P < 0.01 for both variables)., Conclusions: Patients with type 2 diabetes who have DR have an increased burden of cerebral SVD compared with those without DR. Our findings suggest that the brain is a target organ for microangiopathy, similar to other classic target organs, like the retina., (© 2016 by the American Diabetes Association.)

Background: The objective of this study was to describe the intake of macronutrient, especially fatty acids, and explore their possible effect on diabetic retinopathy (DR) in patients with type 2 diabetes mellitus., Methods: In this case-control study, we included a total of 146 patients with DR and 148 without DR. The intake of macronutrient was evaluated using a validated food frequency questionnaire. We used logistic regression adjusted for sex, age, diabetes duration, energy intake, educational level, physical activity, waist circumference, systolic blood pressure, high-density lipoprotein cholesterol and diabetes treatment, to estimate odds ratio (ORs) of DR., Results: Patients with DR had significantly lower intake of fibre, monounsaturated fatty acids (MUFA), and palmitic and oleic acid. Inverse associations were observed between MUFA and oleic acid intake in DR. Subjects with intermediate and high MUFA intake were less likely to have DR than those with lower MUFA intake, with ORs of 0.46 (95 % CI: 0.22-0.93) and 0.42 (95 % CI: 0.18-0.97), respectively. Similarly, intermediate and high oleic acid intake were associated with reduced DR frequency compared with low oleic acid intake, with OR values of 0.48 (95 % CI: 0.23-0.97) and 0.37 (95 % CI: 0.16-0.85), respectively. These associations were stronger in patients with a longer diabetes duration., Conclusion: In type 2 diabetes mellitus, MUFA and oleic acid intake were inversely associated with DR.

Objective: The main aim of this study was to assess the association between adherence to the traditional Mediterranean diet (MedDiet) and health-related quality of life (HRQoL) and treatment satisfaction in patients with type 2 diabetes mellitus (T2DM)., Methods: This cross-sectional study included 294 patients with T2DM (146 with diabetic retinopathy and 148 without retinopathy). HRQoL and treatment satisfaction were assessed with the Audit Diabetes-Dependent Quality of Life and Diabetes Treatment Satisfaction Questionnaires, respectively. Adherence to the MedDiet was evaluated with the relative Mediterranean Diet Score (rMED). The rMED was added to multivariate linear regression models to assess its relative contribution as a quantitative as well as a qualitative variable after recoding to maximize each of the model's coefficients of determination to explain quality of life as well as treatment satisfaction dimensions., Results: The adherence to the Mediterranean diet showed no significant association with the overall quality of life score. However, rMED was associated with some HRQoL dimensions: travels, self-confidence and freedom to eat and drink (p = 0.020, p = 0.015, p = 0.037 and p = 0.015, respectively). Concerning treatment satisfaction, rMED was positively associated with its overall score (p = 0.046), and especially with the understanding of diabetes (p = 0.0004) and treatment recommendation (p = 0.036), as well as with the perceived frequency of hyperglycaemias (p = 0.039)., Conclusion: Adherence to the Mediterranean diet was associated with greater treatment satisfaction in patients with T2DM. Although we found no association with overall HRQoL, adherence to this dietary pattern was associated with some quality of life dimensions.

Background: Subjects with type 2 diabetes mellitus are considered to be at high risk for cardiovascular disease. The identification of carotid atherosclerosis is a validated surrogate marker of cardiovascular disease. Nurses are key professionals in the improvement and intensification of cardiovascular preventive strategies., Aims: The aim is to study the presence of carotid atherosclerosis in a group of asymptomatic subjects with type 2 diabetes mellitus and no previous clinical cardiovascular disease., Methods: A total of 187 patients with type 2 diabetes mellitus and 187 age- and sex-matched subjects without type 2 diabetes mellitus were studied in this cross-sectional, observational, cohort study. Standard operational procedures were applied by the nursing team regarding physical examination and carotid ultrasound assessment. Common, bulb, and internal carotid arteries were explored by measuring intima-media thickness and identifying atherosclerotic plaques., Results: Carotid intima-media thickness (c-IMT) and carotid plaque prevalence were significantly greater in diabetic subjects than in the control group. Carotid plaques and c-IMT were more frequent in men than in women and increased with increasing age. In the multivariate analysis, age, gender, waist circumference, systolic blood pressure, and hypercholesterolemia were positively associated with c-IMT, whereas age, gender, and weight were positively associated with carotid plaque., Conclusion: The current nurse-led study shows that subjects with type 2 diabetes mellitus have a high prevalence of subclinical atherosclerosis that is associated with cardiovascular risk factors.

Aims. To assess the association of blood oxygen-transport capacity variables with the prevalence of diabetic retinopathy (DR), retinal ischemia, and macular oedema in patients with type 2 diabetes mellitus (T2DM). Methods. Cross-sectional, case-control study (N = 312) with T2DM: 153 individuals with DR and 159 individuals with no DR. Participants were classified according to the severity of DR and the presence of retinal ischemia or macular oedema. Hematological variables were collected by standardized methods. Three logistic models were adjusted to ascertain the association between hematologic variables with the severity of DR and the presence of retinal ischemia or macular oedema. Results. Individuals with severe DR showed significantly lower hemoglobin, hematocrit, and erythrocyte levels compared with those with mild disease and in individuals with retinal ischemia and macular oedema compared with those without these disorders. Hemoglobin was the only factor that showed a significant inverse association with the severity of DR [beta-coefficient = -0.52, P value = 0.003] and retinal ischemia [beta-coefficient = -0.49, P value = 0.001]. Lower erythrocyte level showed a marginally significant association with macular oedema [beta-coefficient = -0.86, P value = 0.055]. Conclusions. In patients with DR, low blood oxygen-transport capacity was associated with more severe DR and the presence of retinal ischemia. Low hemoglobin levels may have a key role in the development and progression of DR.

Objective: We hypothesize that in type 1 diabetes vasa vasorum (VV) are affected by microangiopathic changes. For this purpose, we assessed the status of the VV signal in patients with type 1 diabetes., Methods: The VV signal at the arterial adventitia of the common carotid artery was evaluated by contrast-enhanced ultrasound imaging. The VV contrast agent signal was quantified in an plaque-free arterial segment as the ratio of the adventitial signal and that of the lumen of the artery. We studied 113 type 1 diabetic patients, 60 with and 53 without retinopathy and without known cardiovascular disease, and a group of 78 non-diabetic subjects free of cardiovascular risk factors. All study subjects underwent a clinical evaluation., Results: The mean ± standard deviation VV signal of healthy subjects was 0.562 ± 0.135. Type 1 diabetic patients showed a higher adventitial VV signal (0.723 ± 0.128) than non-diabetic subjects (P < 0.0001). After adjustment for cardiovascular risk confounders, this difference remained significant. No differences in VV signal, or common carotid intima-media thickness, between subjects with and without retinopathy were found., Conclusions: Type 1 diabetic patients, independently of their retinopathy status, show an increased angiogenesis of the VV of the common carotid artery compared with non-diabetic subjects. Diabetic microangiopathy, that according to our results would also affect the wall of the large arteries, could be a factor contributing to atherosclerosis in type 1 diabetes mellitus., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Objective: The early identification of the onset of subclinical atheromatosis is essential in reducing the high mortality risk from cardiovascular disease (CVD) worldwide. Although carotid intima-media thickness (cIMT) is the most commonly used early predictor of ongoing atherosclerosis, an experimental model of atherosclerosis, demonstrated that increases in adventitial microvessels (vasa vasorum (VV)) precede endothelial dysfunction. Using the reported accuracy of contrast-enhanced ultrasound (CEU) to measure carotid adventitial VV, this study assessed whether measurements of carotid adventitial VV serve as a marker of subclinical atherosclerotic lesions in a control population with none of the classical risk factors for CVD., Methods and Results: Measurements of cIMT (B-mode ultrasound) and adventitial VV (CEU) were conducted in 65 subjects, 30-70 years old, 48% men, with none of the classical risk factors for CVD. Adventitial VV strongly correlated with its own cIMT only in the left carotid artery. Importantly, the left carotid adventitial VV directly correlated with age., Conclusions: The increases with age in left carotid adventitial VV in individuals with zero risk for atheromatosis suggest that the measurement of carotid adventitial VV could be an accurate and sensitive marker for the diagnosis of subclinical atheromatosis and therefore a prominent tool for monitoring the efficacy of anti-atheromatous therapies.

Background: Cardiovascular disease (CVD) is the leading cause of mortality among subjects with type 2 diabetes (T2D), and diabetic retinopathy (DR) has been associated with an increased risk for CVD. The present study was designed to test the concept that T2D patients with DR, but without previous cardiovascular (CV) events and with normal renal function, have an increased atherosclerotic burden compared with patients without DR., Methods: A cross-sectional study was performed using patients with normal renal function (estimated glomerular filtration rate (eGFR) >60 ml/min) and without previous CV events. A total of 312 patients (men, 51%; mean age, 57 yrs; age range 40-75 yrs) were included in the study; 153 (49%) of the patients had DR. B-mode carotid ultrasound imaging was performed for all of the study subjects to measure the carotid intima-media thickness (cIMT) and carotid plaques in the common carotid artery (CCA), bifurcation and internal carotid artery (ICA)., Results: The percentage of carotid plaques in T2D patients with DR was higher than in T2D patients without DR (68% vs. 52.2%, p = 0.0045), and patients with DR had a higher prevalence of ≥2 carotid plaques (44.4% vs. 21.4%; p < 0.0001). No differences were observed in the cIMT measured at different carotid regions between the patients with or without DR. Using multivariate logistic regression (adjustment for major risk factors for atherosclerosis), DR was independently associated with mean-internal cIMT (p = 0.0176), with the presence of carotid plaques (p = 0.0366) and with carotid plaque burden (≥2 plaques; p < 0.0001)., Conclusions: The present study shows that DR in T2D patients without CVD and with normal renal function is associated with a higher atherosclerotic burden (presence and number of plaques) in the carotid arteries. These patients may be at a higher risk for future CV events; therefore, an ultrasound examination of the carotid arteries should be considered in patients with DR for more careful and individualised CV assessment and follow-up.

There is very few evidences on the role of vitamin D in the development of diabetic retinopathy. The aim of the current study was to explore whether there is an association of vitamin D status and diabetic retinopathy in type 2 diabetes. Two groups of patients were selected: 139 and 144 patients with and without retinopathy, respectively, as assessed by an experienced ophthalmologist. Subjects with advanced late diabetic complications were excluded to avoid confounding biases. 25-Hydroxy-vitamin D3 (25(OH)D) concentrations and vitamin D deficiency were associated with the presence of diabetic retinopathy. Additionally, patients with more advanced stages of retinopathy (grades 2-4) had lower concentrations of 25(OH)D and were more frequently vitamin D deficient as compared with patients not carrying this eye complication. In conclusion, our study confirms the association of vitamin D deficiency with the presence and severity of diabetic retinopathy in type 2 diabetes. Further experimental and prospective studies on this issue are clearly warranted.

Background: To assess quality of life and treatment satisfaction in patients with type 2 diabetes mellitus with diabetic retinopathy (DR) using validated instruments, with comparison to patients without DR., Methods: A prospective cross-sectional study was designed to assess the influence of retinopathy on quality of life and treatment satisfaction in patients with type 2 diabetes mellitus who do not have any other advanced late complications that could interfere with these outcomes. We included 148 patients with DR and 149 without DR, all without other advanced diabetic complications. Quality of life was assessed using the Audit of Diabetes Dependent Quality of Life (ADDQoL) questionnaire, and treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Clinical and treatment variables related to diabetes were also collected. The degree of DR was classified according to the International Clinical Classification System. Multivariate linear regression models were used to model the ADDQoL and DTSQ scores according to sociodemographical and clinical characteristics, and to model the adjusted relationship of DTSQ with ADDQoL. In DR patients, a subanalysis assessed the relationship of these scores with the degree of retinopathy, severity of macular edema, and previous photocoagulation treatment., Results: DR was associated with significantly lower quality of life (p < 0.001), when examining the two general quality of life items and most of the specific domains. Concerning DTSQ, no difference was found in the total score, and only two domains that assess the perception of glycemic control (hyper- and hypoglycemia) showed a worse score in DR (p < 0.001 and p = 0.008, respectively). Quality of life was significantly affected by the severity of DR, and treatment satisfaction was significantly affected by the severity of macular edema. In the multivariate analysis, a significant effect of the interaction between diabetes duration, insulin therapy, and the presence of DR was found for both, ADDQoL and DTSQ., Conclusion: In the absence of other major complications, DR has a negative impact on quality of life in patients with type 2 diabetes. Further, treatment satisfaction was not affected by the presence of DR.

Background: Healthy diet and regular physical activity are powerful tools in reducing diabetes and cardiometabolic risk. Various international scientific and health organizations have advocated the use of new technologies to solve these problems. The PREDIRCAM project explores the contribution that a technological system could offer for the continuous monitoring of lifestyle habits and individualized treatment of obesity as well as cardiometabolic risk prevention., Methods: PREDIRCAM is a technological platform for patients and professionals designed to improve the effectiveness of lifestyle behavior modifications through the intensive use of the latest information and communication technologies. The platform consists of a web-based application providing communication interface with monitoring devices of physiological variables, application for monitoring dietary intake, ad hoc electronic medical records, different communication channels, and an intelligent notification system. A 2-week feasibility study was conducted in 15 volunteers to assess the viability of the platform., Results: The website received 244 visits (average time/session: 17 min 45 s). A total of 435 dietary intakes were recorded (average time for each intake registration, 4 min 42 s ± 2 min 30 s), 59 exercises were recorded in 20 heart rate monitor downloads, 43 topics were discussed through a forum, and 11 of the 15 volunteers expressed a favorable opinion toward the platform. Food intake recording was reported as the most laborious task. Ten of the volunteers considered long-term use of the platform to be feasible., Conclusions: The PREDIRCAM platform is technically ready for clinical evaluation. Training is required to use the platform and, in particular, for registration of dietary food intake., (© 2013 Diabetes Technology Society.)

Objective: To test the concept that diabetic patients with microangiopathy of the retinal microcirculation would also show an involvement of the carotid adventitial microcirculation, we aimed to assess the status of the vasa vasorum (VV) signal, measured by contrast-enhanced carotid ultrasound imaging, in type 2 diabetic patients with and without retinopathy., Methods and Results: Using contrast-enhanced ultrasound imaging, we quantified the signal of the VV of the common carotid artery. We investigated two subgroups of type 2 diabetic patients who did not have previous cardiovascular disease: 51 with retinopathy and 56 without retinopathy. The reference VV signal was measured in a group of 65 healthy volunteers as the ratio of the contrast agent signal of the VV and that of the lumen of the artery. Patients and volunteers also underwent a clinical evaluation. The reference VV signal in the group of 65 healthy volunteers was 0.562 (SD = 0.142). Patients with diabetic retinopathy showed a higher mean adventitial VV signal (0.700; SD = 0.150) than those without retinopathy (0.621; SD = 0.120) (P < 0.0039). This difference remained highly significant after adjusting for cardiovascular risk factors. Common carotid intima-media thickness and carotid plaque prevalence were not different between diabetic subgroups., Conclusions: Type 2 diabetic patients with retinopathy show increased angiogenesis of the VV of the common carotid artery. This suggests the existence of a diabetic microangiopathic complication affecting the wall of the large arteries that may be an important contributor to the cardiovascular disease burden in diabetes mellitus., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)