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RESUMEN Objetivo: Determinar en población infantil con Diabetes tipo 1 (DT1) en tratamiento con infusión subcutánea continua de insulina (ISCI), si asumir responsabilidades de autocuidado tras recibir un programa estructurado de educación terapéutica (PEET) se relaciona con el control metabólico y la calidad de vida (CV). Métodos: Estudio observacional, transversal. Se realizó un sub-análisis retrospectivo. Se incluyeron sujetos con DT1 (edad 9-17 años) en terapia ISCI (>1año) que habían recibido el mismo PEET al inicio de ISCI. Se registraron: grado en que asumían responsabilidades de autocuidado acordes a su edad, control metabólico, CV, nivel de conocimientos sobre diabetes y uso de funciones específicas del dispositivo. Resultados: Se incluyeron 44 pacientes. Los niños que asumieron responsabilidades de autocuidado acordes a su edad presentaron valores de hemoglobina glicada (HbA1c) significativamente menores que los niños que no las asumieron (8,0±0,7% vs. 9,2±1,1%, respectivamente, p1year) were included. All patients received the same structured PEET when initiating ISCI treatment. The degree of self-care age-appropriate responsibilities assumed by children was registered. Data related to metabolic control, diabetes knowledge, use of different pump features, and quality of life were also collected. Results: Forty-four patients were included. Children assuming age-appropriate self-care responsibilities had a significantly lower glycated hemoglobin (HbA1c) value compared to those children who did not take on these responsibilities (8,0±0,7% vs. 9,2±1,1%, p

Although cardiovascular disease (CVD) remains the leading cause of mortality in type 1 diabetes (T1D), the use of cardioprotective drugs is scarce. We aimed to evaluate the impact of carotid ultrasonography (US) on the improvement in cardiovascular risk factors (CVRFs) in T1D.T1D patients without CVD meeting criteria for lipid treatment according to guidelines (age ≥ 40 years, nephropathy and/or ≥ 10 years of diabetes duration with ≥ 1 additional CVRFs) were included. The carotid-US group (US-G) underwent a standardized US protocol and CVRF assessment; recommendations were made according to subclinical atherosclerosis status. The control group (CG) followed usual clinical practice. Changes in CVRFs, specially statin use and LDL cholesterol levels, at 1 year were analysed. A total of 318 patients were included (51.3% female, mean age of 49.1 years and 25.5 years of diabetes duration): 211 in the US-G and 107 in the CG. Participants in the US-G had a higher baseline LDL cholesterol than controls (114 vs. 102 mg/dL; p 0.001). Lipid-lowering treatment was modified in 38.9% in the US-G and 6.5% in the CG (p 0.001). At 1 year, the US-G was more frequently on statins, had lower LDL cholesterol and 27% had stopped smoking (p 0.001 for all). Changes were more pronounced in those with plaques (p 0.001). In multivariate analyses adjusted for age, sex and other CVRFs, belonging to the US-G was independently associated with the intensification of lipid-lowering treatment (OR 10.47 [4.06-27.01]). Propensity score-matching analysis yielded similar results (OR 20.09 [7.86-51.37]).Carotid-US is independently associated with an intensification of lipid-lowering therapy in a high-risk T1D population.

OBJECTIVE To evaluate the concordance between the 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD (ESC/EASD-2019) and the Steno T1 Risk Engine (Steno-Risk) cardiovascular risk scales for individuals with type 1 diabetes (T1D) without cardiovascular disease (CVD) and to analyze the relationships of their use with identification of preclinical atherosclerosis. RESEARCH DESIGN AND METHODS We consecutively selected patients with T1D, without CVD, age ≥40 years, with nephropathy, and/or with ≥10 years of T1D evolution with another risk factor. The presence of plaque at different carotid segments was determined by ultrasonography. Cardiovascular risk was estimated in accord with ESC/EASD-2019 risk groups (moderate/high/very high) and the Steno-Risk ( RESULTS We included 501 patients (53% men, mean age 48.8 years, median T1D duration 26.5 years, 41.3% harboring plaques). Concordance between T1D-specific scales was poor (κ = 0.19). A stepped increase in the presence of plaques according to Steno-Risk category was seen (18.4%, 38.2%, and 64.1%, for low, moderate, and high risk, respectively; P for trend CONCLUSIONS Among T1D patients undergoing primary prevention, use of Steno-Risk seems to result in better recognition of individuals with atherosclerosis in comparison with ESC/EASD-2019. Notwithstanding, carotid ultrasound could improve the categorization of cardiovascular risk.

Hyperglycemia is very common in hospitalized patients and is associated with worse clinical outcomes.We implemented a clinical and educational program to improve the overall glycemic control during hospital admission, and, in patients with HbANon-critical patients admitted to cardiovascular areas between October-2017 and February-2019. The program was led by an advanced nurse practitioner (ANP) and included a semiautomated insulin prescription tool. Program in 3 phases: 1) observation of routine practice, 2) implementation, and 3) follow-up after discharge.During the implementation phase the availability of HbA1c increased from 42 to 81%, and the ANP directly intervened in 73/685 patients (11%), facilitating treatment progression at discharge in 48% (de novo insulin in 36%). One-year after discharge, HbA1c in patients who were admitted during the observation phase with HbA1c8% (n = 101) was higher than similar patients admitted during implementation phase (8,6 ± 1,5 vs. 7,3 ± 1,2%, respectively, p 0,001). We evaluated 47710 point of care capillary blood glucose (POC-glucose) in two 9 months periods (one before, one during the program) in cardiology and cardiovascular surgery wards. POC-glucose ≥250 mg/dl (pre vs. during: cardiology 10,7 vs. 8,4%, and surgery 7,4 vs. 4,5%, both p 0,05) and70 mg/dl (2,3 vs. 0,8% y 1,5 vs 1%, p 0,05), respectively, improved during the program.The program allowed improving inpatient glycemic control, detect patients with poor glycemic control, and optimize metabolic control 1-year after discharge.

Resumen Introduccion La educacion terapeutica es clave en el tratamiento de la diabetes mellitus tipo 2 (DT2). La participacion de una enfermera de practica avanzada (EPA) en diabetes en un Programa de Atencion y Educacion Terapeutica (PAET) en Atencion Primaria (AP) podria mejorar la atencion y los resultados de salud en pacientes en tratamiento con 2 o mas dosis de insulina con mal control metabolico. Nuestro objetivo fue evaluar resultados clinicos, educativos y de satisfaccion de este programa. Material y metodos Estudio prospectivo, longitudinal, de intervencion y valoracion antes y despues del programa, con una duracion de 6 meses con visitas presenciales, telefonicas e intervencion grupal. Resultados Se incluyo a 184 pacientes, de los cuales 161 fueron analizados. El 89,4% de los sujetos fueron incluidos por mal control metabolico (GMCM) y el 10,6% por hipoglucemias de repeticion (GMCH). En el GMCM el descenso promedio de la hemoglobina glucosilada (HbA1c) fue de –1,34 ± 1,45%, sin aumento de hipoglucemias. En el GMCH, disminuyeron las hipoglucemias/semana (2,52 ± 1,66 vs. 0,53 ± 1,06; p Conclusiones La implementacion de un PAET con la incorporacion de una EPA en diabetes en AP permite en su conjunto la mejora de resultados clinicos, educativos y de satisfaccion en pacientes con DT2 tratados con ≥ 2 dosis de insulina y control suboptimo.

To determine the sociodemographic and clinical profile of a representative sample of people with type 1 diabetes mellitus (DM1) in Spain and identify factors associated with glycemic control.A cross-sectional observational study was carried out in adults and children with DM1 treated in 75 Spanish public hospitals, geographically distributed in order to be representative of the Spanish population. Within each center, the patients were included on a consecutive basis as they visited the clinic. They were interviewed, and their clinical histories were reviewed. A descriptive statistical analysis was made, and factors associated with HbAA total of 647 patients were included: 55.3% females, aged 36.6 ± 14.4 years, 97.2% Caucasians, BMI 24.7 ± 4.4 kg/mThe management of patients with DM1 in Spain, as well as the treatment they receive, is similar to that seen in other Western countries. Blood glucose control is associated with educational level, disease duration, and the characteristics of treatment and self-care.

Resumen Objetivos Conocer el perfil sociodemografico y clinico en una muestra representativa de personas con diabetes mellitus tipo 1 (DM1) en Espana, e identificar los factores asociados con el control glucemico. Material y metodos Estudio observacional, transversal en adultos y ninos con DM1 tratados en las consultas de 75 hospitales publicos espanoles, distribuidos geograficamente para ser representativos de la poblacion espanola. Dentro de cada centro, los pacientes fueron incluidos de forma consecutiva segun acudian a consulta. Se les entrevisto y se revisaron sus historias clinicas. Se realizo un analisis estadistico descriptivo y se analizaron los factores asociados con la hemoglobina glicada (HbA1c) utilizando un analisis de regresion lineal multivariante. Resultados Se incluyeron 647 pacientes: 55,3% mujeres, edad 36,6 ± 14,4 anos, 97,2% caucasicos, indice de masa corporal (IMC) 24,7 ± 4,4 kg/m2 (12,1% ≥ 30 kg/m2) y el 74,0% tenia estudios secundarios/universitarios. El 20,2% eran fumadores activos. El tiempo medio desde el diagnostico de DM1 fue de 17,9 ± 12,0 anos. Un 48,7% presentaban comorbilidades, un 19,3% retinopatia y un 16,4% hipotiroidismo. Respecto al tratamiento para la DM1, el 76,5% usaban insulinoterapia basal-bolo y el 20,7% infusion subcutanea continua de insulina (ISCI); el 51,0% de los pacientes utilizaban una ratio insulina/hidratos de carbono (ICR), realizaban 4,6 ± 1,6 autoanalisis de glucemia capilar (AAGC) diaria y el 24,8% utilizaba monitorizacion continua de glucosa (MCG). El valor medio de la HbA1c fue del 7,6 ± 1,1% (30% inferior al 7%). El control metabolico fue mejor (menor HbA1c) a mayor numero de AAGC diarios (B = −0,053; p = 0,009), mayor nivel de estudios (B = 0,461; p Conclusiones El manejo de los pacientes con DM1 en Espana, asi como el tratamiento que reciben, es similar al observado en otros paises occidentales. El control glucemico esta asociado al nivel de estudios, la duracion de la enfermedad y las caracteristicas del tratamiento y autocuidado.

Background and aims Information regarding inflammation and cardiovascular disease (CVD) risk in type 1 diabetes (T1D) or preeclampsia (PE) is scarce. We assessed differences in inflammation markers according to the presence of both conditions and their association with atherosclerosis. Methods and results We recruited 112 women without CVD and last pregnancy ≥5 years previously (n = 28 per group): a)T1D and PE; b)T1D without PE; c)PE without T1D; and d)Controls (without T1D or PE). Groups were matched by several CVD risk factors, and diabetes duration and retinopathy in T1D. Carotid intima-media thickness (IMT) and plaque presence (IMT ≥1.5 mm) were assessed by ultrasonography. Inflammatory markers included classical variables (leucocytes and high-sensitivity C-reactive protein [hsCRP]) and glycoproteins by nuclear magnetic resonance (1H-NMR) spectroscopy (GlycA, GlycB, GlycF and the height/width [H/W] ratios of GlycA and GlycB). The age of the participants was 44.9 ± 7.8 years, and 20.5% harbored plaque. There were no differences in inflammatory markers among the four study groups. Overall, in multivariate-adjusted models, all 1H-NMR-glycoproteins (except GlycB) were positively associated with IMT measures (IMT of bulb and maximum-IMT of any carotid segment; p Conclusions High 1H-NMR-glycoprotein concentrations have a negative impact on carotid atherosclerosis among women with preeclampsia, regardless of T1D status.

Automated insulin delivery (AID) is the most recent advance in type 1 diabetes (T1D) management. It has the potential to achieve glycemic targets without disabling hypoglycemia, to improve quality of life and reduce diabetes distress and burden associated with self-management. Several AID systems are currently licensed for use by people with T1D in Europe, United States, and the rest of the world. Despite AID becoming a reality in routine clinical practice over the last few years, the commercially hybrid AID and other systems, are still far from a fully optimized automated diabetes management tool. Implementation of AID systems requires education and support of healthcare professionals taking care of people with T1D, as well as users and their families. There is much to do to increase usability, portability, convenience and to reduce the burden associated with the use of the systems. Co-design, involvement of people with lived experience of T1D and robust qualitative assessment is critical to improving the real-world use of AID systems, especially for those who may have greater need. In addition to this, information regarding the psychosocial impact of the use of AID systems in real life is needed. The first commercially available AID systems are not the end of the development journey but are the first step in learning how to optimally automate insulin delivery in a way that is equitably accessible and effective for people living with T1D.

Information on the association between diet and cardiovascular disease (CVD) in type 1 diabetes (T1D) is scarce. We assessed the association between biomarkers of fatty acid (FA) intake and the presence of carotid plaques (a surrogate marker of future CVD events) in this high-risk population. Cross-sectional study in 167 consecutive T1D patients without CVD and with at least one of the following: ≥ 40 years, diabetic nephropathy, or ≥ 10 years of T1D duration with another CVD risk factor. The FA profile of erythrocyte membranes was determined by gas chromatography, and the number of carotid plaques (intima-media thickness ≥ 1.5 mm) was assessed by ultrasonography. Regression models were constructed adjusting for classical (age, gender, blood pressure, smoking habit, LDL-cholesterol, body mass index and statins) and T1D-specific risk factors (diabetes duration, HbA1c and chronic complications). A total of 58.7% were men (mean age 48.3 ± 10.3 years, T1D duration 27.2 ± 10.1 years). Sixty-one patients (36.5%) showed carotid plaque. Linoleic acid decreased and all-C18:1trans increased with the number of carotid plaques (none, 1–2, ≥ 3 plaques; p for trend

Background and aims Glycoproteins play a key role in inflammatory and cardiometabolic processes. Their implication in atherosclerosis in type 1 diabetes (T1D) is unknown. We assessed the relationships between classic inflammatory markers, glycoproteins measured by nuclear magnetic resonance (1H-NMR), and preclinical atherosclerosis in these patients. Methods and results We selected patients with T1D, without cardiovascular disease (CVD), with: age ≥40 years, nephropathy (micro/macroalbuminuria), or ≥10 years of evolution with another risk factor. The presence of plaque (intima-media thickness >1.5 mm) was determined by ultrasonography. Concentrations of high-sensitive C-reactive protein (hsCRP), circulating leukocytes (classical inflammation markers) and 1H-NMR-glycoproteins (GlycA, GlycB, GlycF, and the height/width [H/W] ratios of GlycA and GlycB) were determined. We included 189 patients (58% male, age 47.0 [40.7–55.2] years). Thirty-five percent presented plaques (22%, ≥2 plaques). There was no association between hsCRP or leukocytes and atherosclerosis. However, in age- and sex-adjusted models, GlycA, GlycF, and the H/W ratios of GlycA and GlycB gradually increased with the number of plaques (0, 1, ≥2 plaques) only in patients without statins (p Conclusion In T1D individuals without lipid-lowering treatment, 1H-NMR-glycoproteins were independently associated with the presence and amount of carotid atherosclerosis, unlike other classical inflammatory markers. Further studies are needed to ascertain their utility as CVD biomarkers.

Background The estimated glomerular filtration rate (eGFR) and the albumin-to-creatinine ratio (ACR) are risk factors for diabetes-related outcomes. A composite that captures information from both may provide a simpler way of assessing risk. Methods 9115 of 9901 Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) participants with both an ACR and eGFR at baseline were included in this post hoc epidemiologic analysis. The hazard of higher baseline levels of 1/eGFR and natural log transformed ACR (calculated as ln [ACR × 100] to eliminate negative values) and their interaction for incident major adverse cardiovascular events (MACE), kidney outcomes, and deaths was estimated. The hazard of the geometric mean of these two baseline measures (the kidney disease index or KDI) was also assessed. Results A non-linear relationship was observed between 1/eGFR and all three outcomes, and between ln [ACR × 100] and the kidney outcome. There was also a negative interaction between these two risk factors with respect to MACE and death. Conversely, a linear relationship was noted between the KDI and all three outcomes. People in the highest KDI fifth experienced the highest incidence of MACE, death, and the kidney outcome (4.43, 4.56, and 5.55/100 person-years respectively). C statistics for the KDI were similar to those for eGFR and albuminuria. Conclusions The KDI combines the baseline eGFR and ACR into a novel composite risk factor that has a simple linear relationship with incident serious outcomes in people with diabetes and additional CV risk factors. Trial Registration clinicaltrials.gov NCT01394952.

Mercè Vidal Flor,1 Margarida Jansà i Morató,1 Carmen Yoldi Vergara,2 Roque Cardona-Hernández,2 Marga Giménez Alvárez,1 Ignacio Conget Donlo,1 Pilar Isla Pera3 1Diabetes Unit, Department of Endocrinology and Nutrition, Hospital Clínic of Barcelona, Barcelona, Spain; 2Diabetes Unit, Endocrinology Service, Hospital Sant Joan de Déu, Esplugues de Llobregat, Barcelona, Spain; 3School of Nursing, University of Barcelona, Barcelona, SpainCorrespondence: Mercè Vidal Flor, Diabetes Unit, Department of Endocrinology and Nutrition, Hospital Clínic of Barcelona, Villarroel, 170, Barcelona, 08036, Spain, Tel +34 93 2279846, Email mvidal@clinic.catIntroduction: The management of type 1 diabetes (T1D) is especially complex during adolescence when youths are transferred to adult care centres. The objectives of this qualitative study were to: a) determine the expectations of young T1D patients prior to transfer, b) evaluate the transfer process between the 2 centres, and c) evaluate the therapeutic education and care programme (TECP) in the adult centre from their point of view.Material and Methods: Opinion sampling of adolescents from 2018– 2019 was performed: Phase 1: adolescents with T1D prior to transfer to the adult hospital; Phase 2: adolescents with T1D one or two years after transfer and having undergone TECP. A focus group (1.5h) and semi-structured interviews (45 min) were performed and taped, transcribed, and sent to the participants for confirmation. Date analysis was performed of the transcriptions of the focus group and interviews. Fragments were selected and meta-categories created.Results: Eleven youths accepted to participate: 7 in Phase 1, 4 repeated in Phase 2 and 4 more transferred 2 years previously were added. The meta-categories obtained were: 1) perception of the quality of care and therapeutic education in the paediatric hospital. 2) transfer to the adult hospital. 3) experience of the youths 1– 2 years after transfer and having undergone TECP. The data are presented in narrative form and are supported with text fragments of the participants’ discussions.Discussion and conclusions: Analysis of patients’ experience complemented by clinical-educational evaluation of TECP provides understanding of the perspectives of youths on the complexity of living with a chronic disease since childhood. It also provides information regarding the factors favouring quality care and therapeutic education, the complexity of transfer from paediatric to adult care, determination of the strong and weak points and the establishment of strategies to improve the programme.Keywords: Type 1 diabetes, adolescents, transition to adult care, qualitative research, patient experience, therapeutic patient education

Objective: To evaluate the concordance between the ESC/EASD-2019 and the Steno Type 1 Risk Engine (Steno-Risk) cardiovascular risk scales in persons with type 1 diabetes (T1D) without cardiovascular disease (CVD), and to analyze their relationships with preclinical atherosclerosis. Research design and methods: We consecutively selected patients with T1D, without CVD, with: ≥40 years, nephropathy, or ≥10 years of evolution with another risk factor. The presence of plaque at different carotid segments was determined by ultrasonography. Cardiovascular risk was estimated according to ESC/EASD-2019 risk groups (moderate/high/very-high) and the Steno-Risk ( Results: We included 501 patients (53% males, age 48.8 years, T1D duration 26.5 years, 41.3% harboring plaques). Concordance between T1D-specific scales was poor (kappa= 0.19). A stepped increase in the presence of plaques according to the Steno-Risk category was seen (18.4%, 38.2% and 64.1%, for low/moderate/high-risk; p for trend Conclusions: In T1D patient undergoing primary prevention, Steno-Risk seems to better recognize individuals with atherosclerosis in comparison to ESC/EASD-2019. Notwithstanding, carotid ultrasound could improve the categorization of cardiovascular risk.

Evaluation of the degree of adherence to self-care among Spanish type 1 diabetes (T1DM) pediatric population lacks of a validated tool.To cross-culturally adapt and determine the psychometric properties of the Spanish version of the Diabetes Management Questionnaire to assess the degree of adherence to self-care among children with T1DM.Translation, back-translation, and patient suggestions, were considered to obtain the Spanish version (DMQ-Sp). A cross-sectional study was conducted with 323 children (aged 8-18 years) with T1DM and their parents to determine internal reliability, structural validity, and external validity. Responsiveness to change was analyzed through a prospective longitudinal study involving 102 newly diagnosed T1DM patients. Psychometrics were evaluated for the entire sample and stratified by age (8-12 and 13-18 years).A total of 323 children with T1DM [49.8% female; age 13.3 ± 2.8 years; 155 aged 8-12; glycated hemoglobin (HbA1c) value 7.7 ± 1.0%] answered the Spanish final version. The internal consistency Cronbach's alpha was 0.76 and intraclass correlation coefficient 0.84. Test-retest reliability was r = 0.84 (p 0.001). Fit index of structural validity was0.7. External validity correlated inversely with HbA1c (r = -0.39; p 0.001). The DMQ-Sp score increased significantly after 6 months of receiving the full therapeutic education program (TEP) (baseline 57.07 ± 10.81 vs. 6 months 78.80 ± 10.31; p 0.001).The DMQ-Sp is reliable, valid, and sensitive to change in a large sample of children (aged 8-18 years) with T1DM and their parents.DMQ-Sp can be a useful tool for diabetes teams to identify adherence to different tasks and to evaluate TEPs.

Glycemia assessment in people with type 1 diabetes (T1D) has focused on the time spent in different glucose ranges. As this time reflects the relative contributions to the finite duration of a day, it should be treated as compositional data (CoDa) that can be applied to T1D data. Previous works presented a tool for the individual categorization of days and proposed a probabilistic transition model between categories, although validation has hitherto not been presented. In this study, we consider data from eight real adult patients with T1D obtained from continuous glucose monitoring (CGM) sensors and introduce a methodology based on compositional methods to validate the previously presented probability transition model. We conducted 5-fold cross-validation, with both the training and validation data being CoDa vectors, which requires developing new performance metrics. We design new accuracy and precision measures based on statistical error calculations. The results show that the precision for the entire model is higher than 95% in all patients. The use of a probabilistic transition model can help doctors and patients in diabetes treatment management and decision-making. Although the proposed method was tested with CoDa applied to T1D data obtained from CGM, the newly developed accuracy and precision measures apply to any other data or validation based on CoDa.

Objective Evaluate the results of a healthcare and therapeutic education program (TEP) aimed at young patients with type 1 diabetes (T1D) transferred from a pediatric center. Methodology This was a prospective, pre-postest in young T1D patients transferred from 2005–2015. The program has four phases: coordinated transfer, evaluation and objective pacting, knowledge (DKQ2) adherence (SCI-R.es) and quality of life (DQoL and SF12). Results were compared according to Multiple Daily Injections (MDI) vs. Continuous Subcutaneous Insulin Infusion (CSII) and adherence (SCI-R.es 65%). Results A total of 330 patients were transferred (age 18.19 ± 0.82 years, 49% females, glycated hemoglobin [HbA1c] 8.6 ± 1.4%). The program was completed by 68%, and 61% did a group course. While no changes in HbA1c were observed at one year (8.3 ± 1.4 vs. 8.2 ± 1.4%), there were changes in severe hypoglycaemias/patient/year (0.23 ± 0.64 to 0.05 ± 0.34 p 5 hypoglycaemias/patient/week (6.9% vs. 3.9% p = 0.09). DQK2 knowledge increased (25.7 ± 3.6 vs. 27.8 ± 3.8 p Conclusions The TEP improved some parameters of metabolic control without modifying the quality of life in young T1D patients. When comparing patients on MDI vs. CSII, there were no differences in metabolic control but there were when differences were evaluated considering treatment adherence.

Aims Spain has been one of the worst affected countries by the COVID-19 pandemic. A very strict lockdown at home was imposed with a tough restriction of mobility. We aimed to evaluate the impact of this exceptional scenario on glucose profile of patients with type 1 diabetes (T1D) prone to hypoglycaemia using sensor-augmented pump (SAP). Methods Patients with T1D prone to hypoglycaemia using SAP (640G Medtronic-Minimed®) for at least 6 months under the funding of a National Health Service were included in an observational, retrospective study. Data were collected in two periods: pre-lockdown (PL), February 23rd–March 7th and within lockdown (WL), April 1st to 14th 2020. The primary outcome was the difference in the proportion of time in target glucose range of 70–180 mg/dL (TIR). Additional glucometric data and total daily insulin were also analysed. Results Fifty-nine patients were included: 33 women, age 46.17 ± 13.0 years and disease duration of 30.2 ± 12.0 years. TIR 70–180 mg/dL (67.6 ± 11.8 vs. 69.8 ± 12.0%), time > 180 (28.1 ± 13.6 vs. 25.5 ± 13.1%), time > 250 (6.9 ± 6.1 vs. 5.1 ± 4.8) and estimated HbA1c (6.94 ± 0.8 vs. 6.75 ± 0.7%) significantly improved (PL vs. WL, respectively, p

Resumen Objetivo Evaluar la frecuencia de las hipoglucemias desapercibidas (HD) en pacientes con diabetes tipo 1, trasladados de pediatria, que siguen programa especifico de atencion y educacion terapeutica (PAET) en el hospital de adultos. Pacientes y metodos Jovenes trasladados entre 2009-2011. El PAET incluyo proceso de traslado coordinado, visitas individuales y en grupo. Al inicio y a los 12 meses se valoran: HbA1c, frecuencia de hipoglucemias graves paciente/ano (HG) y no graves. Los pacientes fueron clasificados y comparados en 2 grupos: hipoglucemia percibida e HD, segun los resultados del Test de Clarke > 3R respectivamente. Resultados Realizaron PAET 56 pacientes (edad 18,1 ± 0,3 anos, 46% chicas, HbA1c 8,0 ± 1,2%). En la valoracion inicial el 16% presentaba HD. El numero de episodios de HG fue superior en el grupo HD (0,33 ± 0,50 vs. 0,09 ± 0,28 p 2 hipoglucemias no graves/semana fue superior en el grupo HD, aunque sin significacion estadistica (66% vs. 34%, p = 0,06). A los 12 meses todavia un 11% de pacientes presentaba HD. El numero de HG siguio siendo superior en el grupo con HD (0,38 ± 1,06 vs. 0,02 ± 0,15, p = 0,04). Conclusiones El porcentaje de jovenes con diabetes tipo 1 e HD es considerable en el momento del traslado. El PAET mejora su pronostico, pero no lo soluciona a medio plazo. Los pacientes con HD presentan mayor frecuencia de HG. La deteccion de HD es necesaria para reducir las HG que todavia son una asignatura pendiente.

Aim To evaluate frequency of hypoglycaemia unawareness (HU) in patients with type 1 diabetes(T1D) transferred from Paediatrics following a specific therapeutic education programme (TEP) in an adult hospital. Patients and method Young patients transferred from 2009-2011 were evaluated. The TEP included a coordinated transfer process, individual appointments and a group course. At baseline and at 12 months we evaluated glycated haemoglobin (HbA1c) frequency of severe (SH) hypoglycaemia/patient/year and non severe hypoglycaemia (NSH). The patients were classified into two groups and compared: hypoglycaemia awareness (HA) and HU according to the Clarke Test 3R respectively. Results Fifty-six patients (age 18.1 ± 0.3 years, 46% females, HbA1c 8.0 ± 1.2%) underwent the TEP. In the baseline evaluation 16% presented HU. The number of SH was higher in the HU Group (0.33 ± 0.50 vs. 0.09 ± 0.28 p 2 NSH/week was higher, albeit not significantly, in the HU group (66% vs. 34%, p = 0.06). At 12 months 11% of the patients continued to present HU. The number of SH remained higher in the HU group (0.38 ± 1.06 vs.0.02 ± 0.15 p = 0.04). Conclusions The percentage of young people with T1D with HU is quite high at transfer. Although the TEP improves hypoglycaemia awareness it does not solve this important problem. Patients with HU more frequently present SH. It is necessary to identify HU in order to reduce SH which continues to be a problem in people with T1D.

Summary Background Cardiovascular outcome trials have suggested that glucagon-like peptide 1 (GLP-1) receptor agonists might reduce strokes. We analysed the effect of dulaglutide on stroke within the researching cardiovascular events with a weekly incretin in diabetes (REWIND) trial. Methods REWIND was a multicentre, randomised, double-blind, placebo-controlled trial done at 371 sites in 24 countries. Men and women (aged ≥50 years) with established or newly detected type 2 diabetes whose HbA1c was 9·5% or less (with no lower limit) on stable doses of up to two oral glucose-lowering drugs with or without basal insulin therapy were eligible if their body-mass index was at least 23 kg/m2. Participants were randomly assigned (1:1) to weekly subcutaneous injections of either masked dulaglutide 1·5 mg or the same volume of masked placebo (containing the same excipients but without dulaglutide). Randomisation was done by a computer-generated random code with an interactive web response system with stratification by site. Participants, investigators, the trial leadership, and all other personnel were masked to treatment allocation until the trial was completed and the database was locked. During the treatment period, participants in both groups were instructed to inject study drug on the same day at around the same time, each week. Strokes were categorised as fatal or non-fatal, and as either ischaemic, haemorrhagic, or undetermined. Stroke severity was assessed using the modified Rankin scale. Participants were seen at 2 weeks, 3 months, 6 months, and then every 3 months for drug dispensing and every 6 months for detailed assessments, until 1200 confirmed primary outcomes accrued. The primary endpoint was the first occurrence of any component of the composite outcome, which comprised non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular or unknown causes. All analyses were done according to an intention-to-treat strategy that included all randomly assigned participants, irrespective of adherence. The trial is registered with ClinicalTrials.gov , number NCT01394952 . Findings Between Aug 18, 2011, and Aug 14, 2013, we screened 12 133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors were randomly assigned to either dulaglutide (n=4949) or an equal volume of placebo (n=4952). During a median follow-up of 5·4 years, cerebrovascular and other cardiovascular outcomes were ascertained and adjudicated. 158 (3·2%) of 4949 participants assigned to dulaglutide and 205 (4·1%) of 4952 participants assigned to placebo had a stroke during follow-up (hazard ratio [HR] 0·76, 95% CI 0·62–0·94; p=0·010). Dulaglutide reduced ischaemic stroke (0·75, 0·59–0·94, p=0·012) but had no effect on haemorrhagic stroke (1·05, 0·55–1·99; p=0·89). Dulaglutide also reduced the composite of non-fatal stroke or all-cause death (0·88, 0·79–0·98; p=0·017) and disabling stroke (0·74, 0·56–0·99; p=0·042). The degree of disability after stroke did not differ by treatment group. Interpretation Long-term dulaglutide use might reduce clinically relevant ischaemic stroke in people with type 2 diabetes but does not affect stroke severity. Funding Eli Lilly and Company.

The REPRESENT study aims to examine whether participants enrolled in glucagon-like peptide 1 receptor agonist cardiovascular outcome trials (CVOTs) LEADER (liraglutide), REWIND (dulaglutide), and SUSTAIN-6 (injectable semaglutide) are representative of the Spanish population with type 2 diabetes (T2D).This retrospective observational study used the IQVIA Electronic Medical Records database in Spain to identify adults aged 18 years and older with T2D diagnosed before/between January 2013 and December 2015. Demographic and clinical characteristics were analyzed descriptively. The proportions of individuals in the Spanish cohort who met the key selection criteria of each CVOT were calculated from individuals with available database entries for estimated glomerular filtration rate and body mass index using proxies.A total of 24,268 adults with T2D were identified from the IQVIA database. The Spanish cohort was predominantly male (55.5%) and had a mean (± SD) age of 66.8 ± 12.5 years and HbA1c of 7.2 ± 1.5%, with 14.0% having established cardiovascular disease and 2.9% having prior myocardial infarction. The characteristics of the Spanish cohort were more similar to that of REWIND than LEADER or SUSTAIN-6. The proportions of subjects in the Spanish cohort who met the CVOTs key selection criteria were 10.1% for LEADER, 53.6% for REWIND, and 10.4% for SUSTAIN-6.Although none of the CVOTs was fully representative of the Spanish cohort, the REWIND population was found to be more representative of the real-world Spanish population with T2D than those of LEADER and SUSTAIN-6. These findings reinforce the applicability of the results of REWIND in clinical practice.

Nocturnal hypoglycemia (NH) is one of the most challenging events for multiple dose insulin therapy (MDI) in people with type 1 diabetes (T1D). The goal of this study is to design a method to reduce the incidence of NH in people with T1D under MDI therapy, providing a decision-support system and improving confidence toward self-management of the disease considering the dataset used by Bertachi et al. Different machine learning (ML) algorithms, data sources, optimization metrics and mitigation measures to predict and avoid NH events have been studied. In addition, we have designed population and personalized models and studied the generalizability of the models and the influence of physical activity (PA) on them. Obtaining 30 g of rescue carbohydrates (CHO) is the optimal value for preventing NH, so it can be asserted that this is the value with which the time under 70 mg/dL decreases the most, with almost a 35% reduction, while increasing the time in the target range by 1.3%. This study supports the feasibility of using ML techniques to address the prediction of NH in patients with T1D under MDI therapy, using continuous glucose monitoring (CGM) and a PA tracker. The results obtained prove that BG predictions can not only be critical in achieving safer diabetes management, but also assist physicians and patients to make better and safer decisions regarding insulin therapy and their day-to-day lives This work was partially supported by the Spanish Ministry of Science and Innovation through grant PID2019-107722RB-C22/AEI/10.13039/ 501100011033, PID2020-117171RA-I00 funded by MCIN/AEI/ 10.13039/501100011033, the Government of Catalonia under 2017SGR1551 and the EU through the European Regional Development Fund (ERDF) (2018 PROD 00041)

Mathematical modeling of the glucose–insulin system forms the core of simulators in the field of glucose metabolism. The complexity of human biological systems makes it a challenging task for the physiological models to encompass the entirety of such systems. Even though modern diabetes simulators perform a respectable task of simulating the glucose–insulin action, they are unable to estimate various phenomena affecting the glycemic profile of an individual such as glycemic disturbances and patient behavior. This research work presents a potential solution to this problem by proposing a method for the generation of blood glucose values conditioned on plasma insulin approximation of type 1 diabetes patients using a pixel-to-pixel generative adversarial network. Two type-1 diabetes cohorts comprising 29 and 6 patients, respectively, are used to train the generative model. This study shows that the generated blood glucose values are statistically similar to the real blood glucose values, mimicking the time-in-range results for each of the standard blood glucose ranges in type 1 diabetes management and obtaining similar means and variability outcomes. Furthermore, the causal relationship between the plasma insulin values and the generated blood glucose conforms to the same relationship observed in real patients. These results herald the aptness of deep generative models for the generation of virtual patients with diabetes This work was partially supported by the Spanish Ministry of Universities, the European Union through Next GenerationEU (Margarita Salas), the Spanish Ministry of Science and Innovation through grant PID2019107722RBC22/AEI/10.13039/501100011033, PID2020-117171RA-I00 funded by MCIN/AEI/10.13039/501100011033 and the Government of Catalonia under 2017SGR1551 and 2020 FI_B 00965

Purpose Although preeclampsia (PE) is a well-established cardiovascular risk factor (CVRF) in the general population, its role in type 1 diabetes (T1D) has been scarcely studied. We assessed the association between PE and preclinical atherosclerosis in T1D. Methods We recruited 112 women without cardiovascular disease and last pregnancy ≥5 years before: (1) T1D and previous PE (T1D+/PE+; n = 28); (2) T1D without preeclampsia (T1D+/PE–; n = 28); (3) previous PE without T1D (T1D–/PE+; n = 28); and (4) controls (without T1D or PE; T1D–/PE–; n = 28). Groups were matched by age, several CVRFs, and diabetes duration and retinopathy (in T1D participants). Carotid intima-media thickness (IMT) and the presence of plaque (IMT ≥ 1.5 mm) were assessed by standardized ultrasonography protocol. Results Mean age of the participants was 44.9 ± 7.8 years (14.3% hypertension and 21.4% active smokers). Groups including T1D (T1D+/PE+ and T1D+/PE–) more frequently presented hypertension and statin treatment (23.2% vs 5.4% and 37.5% vs 8.9%; respectively; P < 0.01), without differences in other CVRFs. Carotid plaques were observed in 20.5%. In multivariate models adjusted for age, CVRF, and statins, both T1D and PE showed a similar impact on the presence of plaque, with odds ratios (95% confidence interval), 5.45 (1.36–21.9) and 4.24 (1.04–17.3), respectively. Both entities showed an additive effect when combined, both in common carotid-IMT (T1D+/PE– or T1D–/PE+, β = 0.198; T1D+/PE+, β = 0.297) and in the presence of plaque (8.53 [1.07–68.2] and 28.1 [2.67–296.4], respectively). Conclusions Previous PE was independently associated with preclinical atherosclerosis in T1D. Further studies are needed to ascertain its usefulness for stratifying risk in T1D women.

Background: Although cardiovascular disease (CVD) remains the leading cause of mortality in type 1 diabetes (T1D), the use of cardioprotective drugs is scarce. We aimed to evaluate the impact of carotid ultrasonography (US) on the improvement in cardiovascular risk factors (CVRFs) in T1D.Methods: T1D patients without CVD meeting criteria for lipid treatment according to guidelines (age ≥40 years, nephropathy and/or ≥10 years of diabetes duration with ≥1 additional CVRFs) were included. The carotid-US group (US-G) underwent a standardized US protocol and CVRF assessment; recommendations were made according to subclinical atherosclerosis status. The control group (CG) followed usual clinical practice. Changes in CVRFs, specially statin use and LDL-cholesterol levels, at one year were analysed.Results: A total of 318 patients were included (51.3% female, mean age of 49.1 years and 25.5 years of diabetes duration): 211 in the US-G and 107 in the CG. Participants in the US-G had a higher baseline LDL-cholesterol than controls (114 vs. 102 mg/dL; pConclusions: Carotid-US is independently associated with an intensification of lipid-lowering therapy in a high-risk T1D population.

Resumen Objetivo Menos de un tercio de los pacientes con diabetes tipo 1 (DT1) consiguen el objetivo de punto de corte establecido como control metabolico optimo (HbA1c Material y metodos Estudio observacional retrospectivo que incluye a 178 pacientes que iniciaron terapia ISCI de manera consecutiva entre los anos 2003 y 2008. Se han analizado las caracteristicas basales de los individuos, la HbA1c inicial y a los 5 anos de tratamiento con ISCI y la presencia o no de HG. Se calcularon las variables combinadas: a) descenso de al menos 0,5 puntos de HbA1c y ausencia de HG en los ultimos 2 anos; b) HbA1c a los 5 anos Resultados Veintisiete de los 178 pacientes fueron excluidos debido a perdida del seguimiento o abandono de la terapia ISCI. Se analizo a 151 pacientes (edad 37,4 ± 10,5 anos, 64% mujeres, 19,2 ± 10,7 anos de evolucion de la DT1). Las 2 indicaciones principales para el inicio de ISCI fueron: control metabolico suboptimo (60,9%) e HG o hipoglucemia desapercibida (28,5%). Las HbA1c de la cohorte total y de control metabolico suboptimo fueron de 8,0 ± 1,2 y 8,4 ± 1,1% al inicio de la terapia ISCI y de 7,8 ± 1,2 y 8,0 ± 1,3% a los 5 anos (p = 0,104 y p = 0,016), respectivamente. En la cohorte global un 55,5% de los pacientes alcanzaron a los 5 anos el objetivo combinado HbA1c Conclusiones Tras 5 anos de terapia ISCI mas de la mitad de nuestros pacientes consiguen el objetivo combinado de reduccion significativa de HbA1c y ausencia de HG. La utilizacion de objetivos combinados nos ofrece la posibilidad de evaluar la efectividad de las terapias en la DT1 desde un punto de vista mas cercano a su significado clinico.

Background: Diabetic patients treated with intensive insulin therapies require a tight glycemic control and may benefit from advanced tools to predict blood glucose (BG) concentration levels and hypo/hyperglycemia events. Prediction systems using machine learning techniques have mainly focused on applications for sensor augmented pump (SAP) therapy. In contrast, insulin bolus calculators that rely on BG prediction for multiple daily insulin (MDI) injections for patients under self-monitoring blood glucose (SMBG) are scarce because of insufficient data sources and limited prediction capability of forecasting models. Methods: We trained individualized models that can predict postprandial hypoglycemia via different machine learning algorithms using retrospective data from 10 real patients. In addition, we designed and tested a hypoglycemia reduction strategy for a similar in silico population. The system generates a bolus reduction suggestion as the scaled weighted sum of the predictions. We evaluated the general and postprandial glycemic outcomes of the in silico population to assess the systems capability of avoiding hypoglycemias. Results: The median [IQR] sensitivity and specificity for hypoglycemia cases where the BG level was below 70 mg/dL were 0.49 [0.2–0.5] and 0.74 [0.7–0.9], respectively. For hypoglycemia cases where the BG level was below 54 mg/dL, the median [IQR] sensitivity and specificity were 0.51 [0.4–0.6] and 0.74 [0.7–0.8], respectively. Conclusions: The results indicated a decrease of 37% in the median number of postprandial hypoglycemias median decrease of 44% for hypoglycemias of 70 mg/dL and 54 mg/dL, respectively. This dramatic reduction makes this method a good candidate to be integrated into any Decision Support System for diabetes management.

Aims To evaluate the impact of a prepregnancy care (PPC) programme, beyond HbA1c, on hypoglycaemia awareness and glycaemic variability (GV). Methods Prospective pilot study. We selected women with Type 1 diabetes who initiated a PPC programme with normal hypoglycaemia awareness (n = 24). Hypoglycaemia awareness, hypoglycaemic events and GV derived from masked-continuous glucose monitoring were evaluated in the first visit and within 2 weeks after pregnancy confirmation. Results The duration was 16.5 ± 13.0 months. HbA1c significantly decreased (−0.8 ± 0.7; p Conclusions A PPC programme improved HbA1c as well as GV with no significant impact on hypoglycaemia awareness. Moreover, GV could help to identify women less likely to achieve glycaemic targets. Larger studies are needed to confirm these results.

Objective There is scarce information regarding the performance of a specific, structured education program addressed to patients with type 1 diabetes (T1D) using continuous subcutaneous insulin infusion (CSII) including both routine use of the therapy and patient experience evaluation. We aimed to assess the routine use of CSII and patient's experience and satisfaction regarding a specific structured patient self-management education and care program. Methods A retrospective, observational, cross-sectional study collecting CSII routine use downloaded data. Patient experience and satisfaction were evaluated using an anonymous online survey covering different aspects of CSII self-management education and care program. Results 380 T1D subjects were included (aged 45.3 ± 12.17 years, 62.1% women, diabetes duration 27.8 ± 10.3 years, 9.7 ± 4.7 years on CSII, HbA1c 7.7 + 1.0%; 61.0 ± 7.9 mmol/mol). Participants with HbA1c ≤ 7.5% (58 mmol/mol, n = 178) did more SMBGs per day (4.4 ± 2.1 vs. 3.9 ± 1.9); used more boluses (5.0 ± 1.8 vs. 4.5 ± 2.0); the percentage of insulin given as bolus was higher (50.1 ± 12.8 vs. 44.9 ± 13.2%); the night bolus wizard (BW) high glucose target was lower (125.9 ± 4.4 vs. 130.5 ± 12.8 mg/dl) and time on CSII therapy was shorter (8.9 ± 4.6 vs. 10.3 ± 4.6 years. p Conclusions The analysis of routine clinical use of CSII by T1D patients demonstrates that glucose control may be associated with some pump usage and adherence parameters. The overall user experience and satisfaction with our CSII self-management education and care program was remarkably favorable.

Evaluate the relationship between high and low exposure continuous glucose monitoring (CGM)-derived glucometrics and micro- and macrovascular complications in type 1 diabetes (T1D).Cross-sectional study in T1D without cardiovascular disease (CVD) and with ≥ 1 of the following: ≥40 years, diabetic nephropathy, or ≥ 10 years of diabetes duration with CVD risk factors. Glucometrics were obtained over 14 consecutive days: glucose management indicator (GMI) and proportion of time 54 (TBR 54),70, 70-180 (TIR),180 (TAR). Carotid plaque was evaluated by ultrasonography. Logistic regression models adjusted for age, sex, and other risk factors were constructed to test the independent associations with chronic complications.We included 152 patients (54.6% men, 48.7 ± 10.0 years-old). Sixty-seven patients had plaque and n = 71 microvascular complications. TAR (OR 1.28 [1.09-1.51]) and GMI (OR 3.05 [1.46-6.36]) were directly associated with the presence of microvascular complications, while TIR had an inverse relationship (OR 0.79 [0.66-0.93]). TBR 54 was directly associated with the presence of plaque, even after adjusting for 5-year mean HbA1c (OR 1.51 [1.07-2.13]).High-glucose glucometrics were independently associated with microvascular complications. Only low-glucose exposure glucometrics was significantly associated with preclinical atherosclerosis. Our data support the role of hypoglycemia in the development of CVD in this population.

The time spent in glucose ranges is a common metric in type 1 diabetes (T1D). As the time in one day is finite and limited, Compositional Data (CoDa) analysis is appropriate to deal with times spent in different glucose ranges in one day. This work proposes a CoDa approach applied to glucose profiles obtained from six T1D patients using continuous glucose monitor (CGM). Glucose profiles of 24-h and 6-h duration were categorized according to the relative interpretation of time spent in different glucose ranges, with the objective of presenting a probabilistic model of prediction of category of the next 6-h period based on the category of the previous 24-h period. A discriminant model for determining the category of the 24-h periods was obtained, achieving an average above 94% of correct classification. A probabilistic model of transition between the category of the past 24-h of glucose to the category of the future 6-h period was obtained. Results show that the approach based on CoDa is suitable for the categorization of glucose profiles giving rise to a new analysis tool. This tool could be very helpful for patients, to anticipate the occurrence of potential adverse events or undesirable variability and for physicians to assess patients’ outcomes and then tailor their therapies This project has been partially supported by the Spanish Government, Ministerio de Economía y Competitividad (MINECO) (Grants DPI2016-78831-C2-1-R, DPI2016-78831-C2-2-R, RTI2018-095518-B-C21), Agencia Estatal de Investigación (PID2019-107722RB-C21/ AEI/10.13039/501100011033), the National Council of Technological and Scientific Development, CNPq Brazil through Grants 202050/2015-7, 207688/2014-1 and EU through FEDER funds