Impact of an advanced hybrid closed-loop system on glycemic control throughout the menstrual cycle in women with type 1 diabetes prone to hypoglycemia.

This study aimed to evaluate the impact of advanced hybrid closed-loop (AHCL) on glycemic control throughout the menstrual cycle (MC) in women with type 1 diabetes (T1D). We included 39 pairs of spontaneous MC from 13 participants, before and after switching from sensor-augmented pump to AHCL. Baseline time below range <70 mg/dL (TBR<70) was significantly higher during the mid-follicular phase than during late luteal phase (5.7±5.0% vs. 4.1±3.0%), but similar time in range 70-180 mg/dL (TIR) was observed throughout the MC. After switching to AHCL, a reduction in TBR<70 and an increase in TIR were observed in all phases. Phase-dependent changes in insulin infusion were detected and pre-existing differences in TBR<70 were eradicated (3.5±3.2% vs. 3.0±3.0%). However, TIR became significantly higher during the early follicular than during the late luteal phase (79.1±9.3% vs. 74.5±10.0%). In conclusion, AHCL improved glycemic control throughout the MC, but performance differed according to phase.

Effectiveness of flash glucose monitoring in patients with type 1 diabetes and recurrent hypoglycemia between early and late stages after flash glucose monitoring initiation.

AIMS: Evaluate the effectiveness of reimbursed flash glucose monitoring with optional alarms (FGM) in preventing severe hypoglycemia (SH) and reducing hypoglycemia exposure in T1D patients prone to hypoglycemia. METHODS: Ambispective study in T1D patients treated with multiple daily injections (MDI) and prone to hypoglycemia, initiating reimbursed FGM (FreeStyle Libre 2). The primary outcome was the number of SH events (requiring third party assistance) and main secondary outcomes were time below range < 70 (TBR < 70) and < 54 mg/dL (TBR < 54), impaired awareness of hypoglycemia (IAH) and quality of life (QoL). Logistic regression models were constructed to explore variables associated with success of the intervention. RESULTS: We included 110 patients (52.7 % women, mean age 47.8 ± 17.0 years). SH events at 1-year follow-up decreased from 0.3 ± 0.6 to 0.03 ± 0.2 (p < 0.001). Significant reductions in patients presenting an SH (26.4 % vs. 2.9 %, p < 0.001) and IAH (47.1 % vs. 25.9 %, p = 0.002) were observed, as well as improvements in QoL. TBR < 70 and TBR < 54 were not significantly reduced. Baseline GMI was inversely associated with a decrease in TBR < 70 [OR 0.37 (0.15-0.93)] and directly with an increase in time in range 70-180 mg/dL [OR 2.10 (1.03-4.28)]. CONCLUSIONS: FGM decreased SH and improved hypoglycemia awareness and QoL. Initial tight glycemic control was associated with a decrease in hypoglycemia, while patients with suboptimal control reduced hyperglycemia.

Impaired hypoglycaemia awareness in early pregnancy increases risk of severe hypoglycaemia in the mid-long term postpartum irrespective of breastfeeding status in women with type 1 diabetes.

INTRODUCTION: Information regarding the postpartum period in women with type 1 diabetes (T1D) is scarce. We aim to evaluate the relation of impaired hypoglycaemia awareness (IAH) in early pregnancy and breastfeeding status (its presence and duration) with severe postpartum hypoglycaemia (SH). MATERIALS AND METHODS: Retrospective cohort study of women with T1D followed during pregnancy between 2012 and 2019. Data on SH were recorded before and during pregnancy. IAH was evaluated at the first antenatal visit. Data on breastfeeding and the long-term postpartum period were collected by questionnaire and from medical records. RESULTS: A total of 89 women with T1D were included with a median follow-up after pregnancy of 19.2 [8.7-30.5] months. Twenty-eight (32%) women had IAH at the first antenatal visit. At discharge, 74 (83%) started breastfeeding during a median of 8 [4.4-15] months. A total of 18 (22%) women experienced ≥1 SH during postpartum. The incidence of SH significantly increased from pregestational to the gestational and post-partum period (0.09, 0.15 and 0.25 episodes/patient-year, respectively). Postpartum SH rates were comparable in breastfeeding and non-breastfeeding women (21.4% vs. 25%, respectively, p>0.05). Clarke test score at the first antenatal visit was associated with postpartum SH (for each 1-point increase: OR 1.53; 95% CI, 1.06-2.21) adjusted for confounders. No other diabetes and pregnancy-related variables were identified as predictors of SH in this period. CONCLUSIONS: SH are common in the long-term postpartum period independently of breastfeeding. Assessing IAH in early pregnancy could identify those at an increased risk of SH in the postpartum period.

Changes in physical activity habits in subjects with type 1 diabetes: A comparative study 10 years apart.

INTRODUCTION: Physical activity (PA) is highly recommended in type 1 diabetes (T1D). Few studies have reported the amount of PA performed by individuals with T1D in their daily life, and there is no information about changes over time. MATERIAL AND METHODS: Cross-sectional study in patients with T1D from a referral hospital recruited in two different periods: data from the Biobank registers from 2009 and data from patients attending visits at the hospital in 2019, on a consecutive basis. Data included clinical characteristics and the PA assessment through the International Physical Activity Questionnaire-short form (IPAQ-SF). RESULTS: In 2019, participants with T1D (n=135) reported a lower sedentary lifestyle and greater levels of high PA compared to subjects with T1D (n=355) from 10 years earlier (6.7% vs. 14.1% sedentariness, p=0.015; and 52.6% vs. 25.4% of high PA, p<0.001, respectively). Similar results were identified when the groups were divided according to sex. Both groups presented similar distribution by sex (women, 54% vs. 55%), age (40 vs. 39 years old), years with diabetes (20 vs. 18 years), BMI (25 vs. 24kg/m2) and glycated haemoglobin (7.5% vs. 7.5%, respectively; p>0.05 for all comparisons). Sex and age groups were not determinant for sedentary lifestyle in the different years studied. Analysing all the 490 participants, there was an inverse correlation of age with sitting hours (p=0.024, r=-0.102), total METs (p<0.001, r=-0.146) and HbA1c (p=0.038, r=-0.097). No correlations were found between PA and HbA1c or BMI. CONCLUSIONS: The findings indicate that PA has significantly increased in subjects with T1D over the last 10 years. Future studies are needed to assess whether these healthier habits translate into better outcomes in this high-risk population.

Characteristics of people with type 1 diabetes who use technology in their treatment and who use frequently the technical assistance teleconsultation service.

INTRODUCTION: Technical issues related to continuous subcutaneous insulin infusion (CSII), associated or not with continuous glucose monitoring (SAP), are handled by tele-technical assistance from the manufacturer. We analyze the characteristics of the most demanding patients of technical teleassistance. MATERIAL AND METHODS: Patients with type 1 diabetes (T1D) in treatment with CSII or SAP, who made use of technical teleassistance from 01/01/2017 to 02/28/2021 (2298 consultations) were included. We selected the group of patients who made ≥10 calls (90th percentile, P90) and the one who made a single call (10th percentile, P10). The number and most frequent reasons for consultation, clinical characteristics and HbA1c were collected and both groups were compared. RESULTS: 51 patients (P90) made a total of 876 calls (38.1% of calls), 32 used SAP. The most frequent reason for consultation was related to continuous glucose monitoring (36.8%). 51 (P10) made 51 calls (2.2%), 3 used SAP. The most frequent reason for consultation was related to device damage (25.5%). The most demanding patients used SAP more frequently (62.7 vs. 5.9%, P < .001), had been in advanced treatment for less time (7.1 ±â€¯5.5 vs. 12.1 ±â€¯6.2 years, P < .001) and their HbA1c was lower (7.2 ±â€¯0.9 vs 7.6 ±â€¯0.8%). CONCLUSIONS: Most of the calls to the technical teleassistance service for ISCI/SAP devices come from a more demanding group of people with T1D. The greatest demand is concentrated in patients who use SAP, with a shorter time of use of advanced therapy and a better degree of glucose control.

Assessing Apps for Health Care Workers Using the ISYScore-Pro Scale: Development and Validation Study.

BACKGROUND: The presence of mobile phone and smart devices has allowed for the use of mobile apps to support patient care. However, there is a paucity in our knowledge regarding recommendations for mobile apps specific to health care professionals. OBJECTIVE: The aim of this study is to establish a validated instrument to assess mobile apps for health care providers and health systems. Our objective is to create and validate a tool that evaluates mobile health apps aimed at health care professionals based on a trust, utility, and interest scale. METHODS: A five-step methodology framework guided our approach. The first step consisted of building a scale to evaluate apps for health care professionals based on a literature review. This was followed with expert panel validation through a Delphi method of (rated) web-based questionnaires to empirically evaluate the inclusion and weight of the indicators identified through the literature review. Repeated iterations were followed until a consensus greater than 75% was reached. The scale was then tested using a pilot to assess reliability. Interrater agreement of the pilot was measured using a weighted Cohen kappa. RESULTS: Using a literature review, a first draft of the scale was developed. This was followed with two Delphi rounds between the local research group and an external panel of experts. After consensus was reached, the resulting ISYScore-Pro 17-item scale was tested. A total of 280 apps were originally identified for potential testing (140 iOS apps and 140 Android apps). These were categorized using International Statistical Classification of Diseases, Tenth Revision. Once duplicates were removed and they were downloaded to confirm their specificity to the target audience (ie, health care professionals), 66 remained. Of these, only 18 met the final criteria for inclusion in validating the ISYScore-Pro scale (interrator reliabilty 92.2%; kappa 0.840, 95% CI 0.834-0.847; P<.001). CONCLUSIONS: We have developed a reproducible methodology to objectively evaluate mobile health apps targeted to health care professionals and providers, the ISYScore-Pro scale. Future research will be needed to adapt the scale to other languages and across other domains (eg, legal compliance or security).

Management of glucose profile throughout strict COVID-19 lockdown by patients with type 1 diabetes prone to hypoglycaemia using sensor-augmented pump.

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 < 0.05). Time in hypoglycaemia, coefficient of variation, sensor usage and total daily insulin dose remained unchanged. CONCLUSIONS: Lockdown conditions imposed by the COVID-19 pandemic may be managed successfully in terms of glycaemia control by population with DT1 prone to hypoglycaemia using SAP. The strict daily routine at home could probably explain the improvement in the time in glycemic target without increasing the time hypoglycaemia.

The impact of strict COVID-19 lockdown in Spain on glycemic profiles in patients with type 1 Diabetes prone to hypoglycemia using standalone continuous glucose monitoring.

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 T1D prone to hypoglycemia using standalone continuous glucose monitoring. METHODS: Patients with T1D prone to hypoglycemia using multiple daily injections and either a Dexcom G5® or a Free Style Libre® CGM systems for at least 6 months under the funding of 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-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 were also analysed. RESULTS: 92 patients were included: 40 women, age 42.8 ± 3.9 years, disease duration of 23.1 ± 12.6 years. Seventeen patients used Dexcom G5® and 75 Free Style Libre®. TIR 70-180 mg/dL (59.3 ± 16.2 vs 62.6 ± 15.2%), time > 180 (34.4 ± 18.0 vs 30.7 ± 16.9%), >250 (11.1 ± 10.6 vs 9.2 ± 9.7%) and Glucose Management Indicator (7.2 ± 0.8 vs 7.0 ± 0.8%) significantly improved (PL vs WL, respectively, p < 0.05). Time in hypoglycemia remained unchanged. CONCLUSIONS: Lockdown conditions imposed by the COVID-19 pandemic may be managed successfully in terms of glycemic control by population with T1D prone to hypoglycemia using CGM. The strict daily routine at home could probably explain the improvement in the time in glycemic target without increasing the time in hypoglycemia.

Hipoglucemia desapercibida en jóvenes con diabetes tipo 1 trasladados a un centro de adultos / Hypoglycaemia unawareness in young people with type 1 diabetes transferred to an adult center

OBJETIVO: Evaluar la frecuencia de las hipoglucemias desapercibidas (HD) en pacientes con diabetes tipo 1, trasladados de pediatría, que siguen programa específico de atención y educación terapéutica (PAET) en el hospital de adultos. PACIENTES Y MÉTODOS: Jóvenes trasladados entre 2009-2011. El PAET incluyó proceso de traslado coordinado, visitas individuales y en grupo. Al inicio y a los 12 meses se valoran: HbA1c, frecuencia de hipoglucemias graves paciente/año (HG) y no graves. Los pacientes fueron clasificados y comparados en 2 grupos: hipoglucemia percibida e HD, según los resultados del Test de Clarke < 3R o > 3R respectivamente. RESULTADOS: Realizaron PAET 56 pacientes (edad 18,1±0,3 años, 46% chicas, HbA1c 8,0 ± 1,2%). En la valoración inicial el 16% presentaba HD. El número de episodios de HG fue superior en el grupo HD (0,33 ± 0,50 vs. 0,09 ± 0,28 p < 0,05). El porcentaje de pacientes con > 2 hipoglucemias no graves/semana fue superior en el grupo HD, aunque sin significación estadística (66% vs. 34%, p = 0,06). A los 12 meses todavía un 11% de pacientes presentaba HD. El número de HG siguió siendo superior en el grupo con HD (0,38 ± 1,06 vs. 0,02 ± 0,15, p = 0,04). CONCLUSIONES: El porcentaje de jóvenes con diabetes tipo 1 e HD es considerable en el momento del traslado. El PAET mejora su pronóstico, pero no lo soluciona a medio plazo. Los pacientes con HD presentan mayor frecuencia de HG. La detección de HD es necesaria para reducir las HG que todavía son una asignatura pendiente

OBJECTIVE: 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 METHODS: 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 or > 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 < .05). The percentage of patients with > 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 = .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

Mobile Health Projects in a High-Complexity Reference Hospital: Case Study.

BACKGROUND: The widespread adoption of mobile and wearable devices and apps makes it essential to assess their possible impact on the management of health and diseases. Health care providers (HCPs) find themselves faced with a new situation in their setting with the proliferation of mobile health (mHealth) intervention tests. Few studies have addressed the development of mHealth and the methodologies to manage these apps in a tertiary hospital. OBJECTIVE: The aim of this study was to evaluate the mHealth projects implemented in the Hospital Clínic of Barcelona to increase awareness of the context in which they are used and to develop policies for the development of good practice in mHealth innovation. METHODS: A prospective, descriptive cross-sectional study was conducted in a highly specialized university hospital with 850 beds for adults and a reference population of 520,000 inhabitants. A specific questionnaire was developed based on the Mobile Health 5 Dimensions European (MOHE 5D-EU) theoretical model to find mHealth projects. Apps, telemedicine, and wearable devices were included in the systematic search. For that purpose, a vertical (top-down) email-based snowball process was conducted. Data were collected from February to December 2018 by conducting personal interviews with HCPs using a structured questionnaire. RESULTS: During the study period, 45 interviews were conducted; 35 mHealth initiatives were found, with 25 targeted to patients and 10 to health professionals. Most mHealth initiatives (34/35, 97%) were related to the software field (apps and telemedicine initiatives), and one was related to wearable devices. Among the projects, 68% (24/35) were classified as medical devices or developments at the edge (developments susceptible to limitations depending on the intended use). In relation to data protection, 27 initiatives managing personal data (27/35, 77%) considered data protection legislation. Only 9% (3/35) of the initiatives had foreseen the use of interconnectivity standards. Most of the initiatives were funded by grants (14/35, 40%), sponsorships (5/35, 14%), or the hospital itself (5/35, 14%). In terms of clinical management, most projects were developed in the field of research, followed by professional tools, clinical information, and therapeutic education. Only 6 projects were involved with health care; all were led by either the industry or small and medium enterprises. CONCLUSIONS: This study helped create the design of a map of the mHealth projects conducted in our hospital that showed the stages of development of the different ongoing projects. This will allow monitoring of mHealth projects and construction of tools to reinforce areas with detected deficiencies. Our theoretical approach using a modified MOHE 5D-EU model was found to be useful for analyzing the characteristics of mHealth projects.

Hypoglycaemia unawareness in young people with type 1 diabetes transferred to an adult center. / Hipoglucemia desapercibida en jóvenes con diabetes tipo 1 trasladados a un centro de adultos.

OBJECTIVE: 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 METHODS: 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 or>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<.05). The percentage of patients with>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=.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.

Evaluación de la efectividad de la terapia ISCI a largo plazo mediante el objetivo combinado de descenso de HbA1c y ausencia de hipoglucemia grave / Assessment of the effectiveness of long-term insulin pump therapy using a combined goal of HbA1c decrease and absence of severe hypoglycemia

Objetivo: Menos de un tercio de los pacientes con diabetes tipo 1 (DT1) consiguen el objetivo de punto de corte establecido como control metabólico óptimo (HbA1c < 7%). Sin embargo, reducciones porcentuales de HbA1c y la prevención de hipoglucemias graves (HG) han demostrado beneficios clínicamente relevantes. Por ello, el objetivo de este estudio ha sido evaluar la efectividad de la terapia con infusión subcutánea continua de insulina (ISCI) a los 5 años de seguimiento en una cohorte de pacientes de una unidad especializada mediante objetivos combinados de descenso de HbA1c y ausencia de HG. Material y métodos: Estudio observacional retrospectivo que incluye a 178 pacientes que iniciaron terapia ISCI de manera consecutiva entre los años 2003 y 2008. Se han analizado las características basales de los individuos, la HbA1c inicial y a los 5 años 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 últimos 2 años; b) HbA1c a los 5 años < 7,5% sin HG en los últimos 2 años; c) HbA1c < 8,5% sin HG en los últimos 2 años, y d) descenso ≥ 0,5 puntos y/o HbA1c < 7,5% a los 5 años sin presencia de HG en los 2 últimos años de seguimiento. Resultados: Veintisiete de los 178 pacientes fueron excluidos debido a pérdida del seguimiento o abandono de la terapia ISCI. Se analizó a 151 pacientes (edad 37,4 ± 10,5 años, 64% mujeres, 19,2 ± 10,7 años de evolución de la DT1). Las 2 indicaciones principales para el inicio de ISCI fueron: control metabólico subóptimo (60,9%) e HG o hipoglucemia desapercibida (28,5%). Las HbA1c de la cohorte total y de control metabólico subóptimo 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 años (p = 0,104 y p = 0,016), respectivamente. En la cohorte global un 55,5% de los pacientes alcanzaron a los 5 años el objetivo combinado HbA1c < 7,5% y/o un descenso ≥ 0,5% sin HG. Conclusiones: Tras 5 años de terapia ISCI más de la mitad de nuestros pacientes consiguen el objetivo combinado de reducción significativa de HbA1c y ausencia de HG. La utilización de objetivos combinados nos ofrece la posibilidad de evaluar la efectividad de las terapias en la DT1 desde un punto de vista más cercano a su significado clínico

Objective: Less than one third of patients with type 1 diabetes mellitus (T1DM) achieve the cut-off value proposed as good metabolic control by most guidelines, HbA1c < 7%. However, HbA1c reductions and prevention of severe hypoglycemia (SH) have shown clinically relevant benefits. The study objective therefore was to assess the effectiveness of continuous subcutaneous insulin infusion (CSII) therapy at 5 years of follow-up in a cohort of patients attending a specialized unit using HbA1c reduction and abscence of SH as combined goals. Methods: A retrospective, observational study on 178 patients with T1DM who started CSII treatment at Hospital Clinic of Barcelona between 2003 and 2008. HbA1c levels at baseline and after 5 years of treatment with CSII and presence or absence of SH were recorded. The combined variables calculated included: a) HbA1c reduction by ≥ 0.5 points and absence of SH in the last 2 years; b) HbA1c at 5 years < 7.5% and no SH in the last 2 years; c) HbA1c < 8.5% and no HG in the last 2 years, and d) HbA1c reduction by ≥ 0.5 points and/or HbA1c < 7.5% at 5 years with no SH in the last 2 years of follow-up. Results: Twenty-seven of the 178 patients were excluded due to loss to follow-up or CSII discontinuation. A total of 151 patients (aged 37.4 ± 10.5 years, 64% women, diabetes duration of 19.2 ± 10.7 years) were therefore analyzed. The 2 main reasons for starting CSII were suboptimal metabolic control (60.9%) and severe hypoglycemia/hypoglycemia unawareness (28.5%). HbA1c levels in the total cohort and in patients with suboptimal metabolic control were 8.0 ± 1.2 and 8.4 ± 1.1% at CSII start and 7.8 ± 1.2 and 8.0 ± 1.3% at 5 years of treatment (P = .104 and P = .016) respectively. In the overall cohort, 55.5% of patients achieved at 5 years the combined goal of HbA1c < 7.5% and/or HbA1c reductions ≥ 0.5% without SH. Conclusions: After 5 years of CSII therapy, more than half of the patients achieved the combined goal of significant HbA1c reduction and absence of SH. The use of combined goals offers the opportunity to assess the effectiveness of T1DM treatment from a clinically more meaningful point of view

Assessment of the effectiveness of long-term insulin pump therapy using a combined goal of HbA1c decrease and absence of severe hypoglycemia. / Evaluación de la efectividad de la terapia ISCI a largo plazo mediante el objetivo combinado de descenso de HbA1c y ausencia de hipoglucemia grave.

OBJECTIVE: Less than one third of patients with type 1 diabetes mellitus (T1DM) achieve the cut-off value proposed as good metabolic control by most guidelines, HbA1c<7%. However, HbA1c reductions and prevention of severe hypoglycemia (SH) have shown clinically relevant benefits. The study objective therefore was to assess the effectiveness of continuous subcutaneous insulin infusion (CSII) therapy at 5 years of follow-up in a cohort of patients attending a specialized unit using HbA1c reduction and abscence of SH as combined goals. METHODS: A retrospective, observational study on 178 patients with T1DM who started CSII treatment at Hospital Clinic of Barcelona between 2003 and 2008. HbA1c levels at baseline and after 5 years of treatment with CSII and presence or absence of SH were recorded. The combined variables calculated included: a) HbA1c reduction by≥0.5 points and absence of SH in the last 2 years; b) HbA1c at 5 years<7.5% and no SH in the last 2 years; c) HbA1c<8.5% and no HG in the last 2 years, and d) HbA1c reduction by≥0.5 points and/or HbA1c<7.5% at 5 years with no SH in the last 2 years of follow-up. RESULTS: Twenty-seven of the 178 patients were excluded due to loss to follow-up or CSII discontinuation. A total of 151 patients (aged 37.4±10.5 years, 64% women, diabetes duration of 19.2±10.7 years) were therefore analyzed. The 2 main reasons for starting CSII were suboptimal metabolic control (60.9%) and severe hypoglycemia/hypoglycemia unawareness (28.5%). HbA1c levels in the total cohort and in patients with suboptimal metabolic control were 8.0±1.2 and 8.4±1.1% at CSII start and 7.8±1.2 and 8.0±1.3% at 5 years of treatment (P=.104 and P=.016) respectively. In the overall cohort, 55.5% of patients achieved at 5 years the combined goal of HbA1c<7.5% and/or HbA1c reductions≥0.5% without SH. CONCLUSIONS: After 5 years of CSII therapy, more than half of the patients achieved the combined goal of significant HbA1c reduction and absence of SH. The use of combined goals offers the opportunity to assess the effectiveness of T1DM treatment from a clinically more meaningful point of view.

Experiences and real life management of insulin pump therapy in adults with type 1 diabetes / Experiencias y gestión en la vida real del tratamiento con bomba de insulina de adultos con diabetes tipo 1

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±7.9mmol/mol). Participants with HbA1c≤7.5% (58mmol/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±12.8mg/dl) and time on CSII therapy was shorter (8.9±4.6 vs. 10.3±4.6 years. p<0.05 all comparisons). More SMBG/day, shorter duration of CSII treatment, a lower BW low glucose target at night, a lower BW high glucose target at night, total insulin dose per day and total number of carbohydrates per day were related with better HbA1c levels. 60% of 373 patients answered the questionnaire. The response to the different aspects of the educational program was homogeneously highly satisfactory. Seventy-seven percent of patients scored the program as very useful. Ninety-three percent of CSII users would not return to their previous insulin treatment. 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

Objetivo: Hay poca información sobre la eficacia de un programa educativo estructurado específico dirigido a los pacientes con diabetes tipo 1 (DT1) que utilizan infusión subcutánea continua de insulina (ISCI) que incluye tanto el uso habitual del tratamiento como la evaluación de la experiencia de los pacientes. Nuestro objetivo era valorar el uso habitual de la ISCI, la experiencia y la satisfacción del paciente con un programa educativo y asistencial estructurado específico para autogestión de los pacientes. Métodos: Estudio transversal retrospectivo observacional en el que se recogieron datos descargados sobre el uso habitual de la ISCI. Se evaluaron la experiencia y la satisfacción de los pacientes mediante una encuesta en línea anónima que abarcaba distintos aspectos del programa educativo y asistencial para autogestión de la ISCI. Resultados: Se incluyó a 380 pacientes con DT1 (45,3±12,17 años de edad, 62,1% mujeres, duración de la diabetes 27,8±10,3 años, 9,7±4,7 años con ISCI, HbA1c 7,7+1,0%; 61,0±7,9mmol/mol). Los participantes con HbA1c<7,5% (58mmol/mol, n=178) practicaron más autocontroles al día (4,4±2,1 vs. 3,9±1,9); usaron más bolos (5,0±1,8 vs. 4,5±2,0); tuvieron un porcentaje de insulina administrada en bolo mayor (50,1±12,8 vs. 44,9±13,2%) y el objetivo de glucosa nocturna alta en el recomendador de bolo (bolus wizard, BW) era más bajo (125,9±4,4 vs. 130,5±12,8mg/dl), y su tiempo con ISCI era menor (8,9±4,6 vs. 10,3±4,6 años, p<0,05 para todas las comparaciones). Más autocontroles al día, la menor duración del tratamiento con ISCI, un objetivo de glucosa baja del BW menor por la noche, un objetivo de glucosa alta del BW por la noche menor, la dosis total diaria de insulina y el número total de hidratos de carbono diarios estaban relacionados con mejores valores de HbA1c. El 60% de 373 pacientes contestaron el cuestionario. La respuesta a los distintos aspectos del programa educativo fue muy satisfactoria en conjunto. El 77% de los pacientes valoraron el programa como muy útil. El 93% de los usuarios de ISCI no volverían el tratamiento de insulina previo. Conclusiones: El análisis del uso clínico sistemático de la ISCI por pacientes con DT1 demuestra que el control de la glucosa puede relacionarse con algunos parámetros de uso y cumplimiento de la bomba. La experiencia global del usuario y la satisfacción con nuestro programa educativo y asistencial de autogestión de la ISCI fueron notablemente favorables

Experiences and real life management of insulin pump therapy in adults with type 1 diabetes.

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±7.9mmol/mol). Participants with HbA1c≤7.5% (58mmol/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±12.8mg/dl) and time on CSII therapy was shorter (8.9±4.6 vs. 10.3±4.6 years. p<0.05 all comparisons). More SMBG/day, shorter duration of CSII treatment, a lower BW low glucose target at night, a lower BW high glucose target at night, total insulin dose per day and total number of carbohydrates per day were related with better HbA1c levels. 60% of 373 patients answered the questionnaire. The response to the different aspects of the educational program was homogeneously highly satisfactory. Seventy-seven percent of patients scored the program as very useful. Ninety-three percent of CSII users would not return to their previous insulin treatment. 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.

The efficiency of telemedicine to optimize metabolic control in patients with type 1 diabetes mellitus: Telemed study.

OBJECTIVE: This study evaluated the impact of an Internet-based telematic system on the economic and clinical management of patients with type 1 diabetes mellitus. RESEARCH DESIGN AND METHODS: This 6-month prospective, randomized, comparative, open, multicenter study included patients with type 1 diabetes >18 years old treated with multiple insulin doses and with a glycated hemoglobin (HbA1c) level of >8%. We compared an intervention group (IG) (two face-to-face and five telematic appointments) with a control group (CG) (seven face-to-face appointments). The variables studied were (1) patient and healthcare team costs, (2) metabolic control, (3) knowledge of diabetes, (4) quality of life, and (5) self-care treatment adherence. RESULTS: Of the 154 patients included, 118 (76.6%) completed the study (IG, 54; CG, 64). The time used by the CG to follow the program was 823±645 min versus 353±222 min in the IG (P<0.0001). Compared with the CG, the IG required less healthcare time from the professionals (288±105 min vs. 232±89 min; P<0.001). HbA1c improved in both groups (IG, 9.2±1.5% [77.0±17.0 mmol/mol] vs. 8.7±1.5% [71.6±17.0 mmol/mol] [P<0.001]; CG, 9.2±0.9% [77.0±10.0 mmol/mol] vs. 8.6±0.9% [70.5±10.0 mmol/mol] [P<0.001], as did knowledge and self-care treatment adherence. CONCLUSIONS: The use of interactive telematic appointments in subjects with type 1 diabetes and inadequate metabolic control is an efficient strategy, providing results comparable to those of face-to-face appointments in relation to improvement in glycemic control, knowledge acquisition, and self-care treatment adherence, with a significant reduction in the time used, especially by patients.

Psychometric analysis of the Spanish and Catalan versions of the Diabetes Self-Care inventory-revised version questionnaire.

BACKGROUND: The purpose of this study was to validate the Spanish and Catalan versions of the Diabetes Self-Care Inventory-Revised Version (SCI-R) questionnaire to assess the degree of adherence to self-care among adults with diabetes. METHODS: We validated the Spanish and Catalan translation from, and back translation to, English and cultural adaptation of the SCI-R in type 1 diabetes patients on multiple insulin doses or continuous subcutaneous insulin infusion and in type 2 diabetes patients on oral agents and/or insulin. Internal reliability, structural validity, and external validity (correlation with glycated hemoglobin) were evaluated. Responsiveness to change was assessed in patients 1 year after onset of type 1 diabetes and following a structured education program. RESULTS: The SCI-R presented good internal reliability Cronbach's α: 0.75, test-retest reliability (r = 0.82) and structural validity (r > 0.40). The external validity was also good; the SCI-R correlated with HbA1c in patients with type 1 diabetes on multiple insulin doses (r = -0.50) or continuous subcutaneous insulin infusion (r = -0.66) and in patients with type 2 diabetes on multiple insulin doses (r = -0.62). However, it was not satisfactory in patients on oral agents (r = -0.20) and/or bedtime insulin (r = -0.35). Responsiveness to change was analyzed in 54 patients (age 27.3±7.4 years, 26% men, HbA1c 6.8% ±1.1%); the SCI-R score was 72.3% ±13.7% and correlated negatively with glycated hemoglobin (r = -0.42) and 3 scales of the Diabetes Quality of Life questionnaire (lower score indicating better perception): Impact (r = -0.37), Social Worry (r = -0.36) and Diabetes Worry (r = -0.38), all at P < 0.05. CONCLUSION: The Spanish and Catalan versions of the SCI-R questionnaire show good psychometric properties and both could be considered as useful tools for evaluating self-care behavior in patients with type 1 or type 2 diabetes. However, there are still some subgroups of patients with type 2 diabetes in which the validity of this questionnaire needs further evaluation.

Relative adrenal insufficiency in decompensated cirrhosis: Relationship to short-term risk of severe sepsis, hepatorenal syndrome, and death.

UNLABELLED: The prevalence of relative adrenal insufficiency (RAI) in critically ill cirrhosis patients with severe sepsis is over 60% and associated features include poor liver function, renal failure, refractory shock, and high mortality. RAI may also develop in noncritically ill cirrhosis patients but its relationship to the clinical course has not yet been assessed. The current study was performed in 143 noncritically ill cirrhosis patients admitted for acute decompensation. Within 24 hours after hospitalization adrenal function, plasma renin activity, plasma noradrenaline and vasopressin concentration, and serum levels of nitric oxide, interleukin-6 and tumor necrosis factor alpha were determined. RAI was defined as a serum total cortisol increase <9 µg/dL after 250 µg of intravenous corticotropin from basal values <35 µg/dL. Patients were followed for 3 months. RAI was detected in 26% of patients (n = 37). At baseline, patients with RAI presented with lower mean arterial pressure (76 ± 12 versus 83 ± 14 mmHg, P = 0.009) and serum sodium (131 ± 7 versus 135 ± 5 mEq/L, P = 0.007) and higher blood urea nitrogen (32 ± 24 versus 24 ± 15 mg/dl, P = 0.06), plasma renin activity (7.1 ± 9.9 versus 3.4 ± 5.6 ng/mL*h, P = 0.03), and noradrenaline concentration (544 ± 334 versus 402 ± 316 pg/mL, P = 0.02). During follow-up, patients with RAI exhibited a higher probability of infection (41% versus 21%, P = 0.008), severe sepsis (27% versus 9%, P = 0.003), type-1 hepatorenal syndrome (HRS) (16% versus 3%, P = 0.002), and death (22% versus 7%, P = 0.01). CONCLUSION: RAI is frequent in noncritically ill patients with acute decompensation of cirrhosis. As compared with those with normal adrenal function, patients with RAI have greater impairment of circulatory and renal function, higher probability of severe sepsis and type-1 HRS, and higher short-term mortality.

Prevalence and risk factors of infections by multiresistant bacteria in cirrhosis: a prospective study.

UNLABELLED: Epidemiology, risk factors, and clinical effect of infections by multiresistant bacteria in cirrhosis are poorly known. This work was a prospective evaluation in two series of cirrhotic patients admitted with infection or developing infection during hospitalization. The first series was studied between 2005 and 2007 (507 bacterial infections in 223 patients) and the second between 2010 and 2011 (162 bacterial infections in 110 patients). In the first series, 32% of infections were community acquired (CA), 32% healthcare associated (HCA), and 36% nosocomial. Multiresistant bacteria (92 infections; 18%) were isolated in 4%, 14%, and 35% of these infections, respectively (P < 0.001). Extended-spectrum ß-lactamase-producing Enterobacteriaceae (ESBL-E; n = 43) was the main multiresistant organism identified, followed by Pseudomonas aeruginosa (n = 17), methicillin-resistant Staphylococcus aureus (n = 14), and Enterococcus faecium (n = 14). The efficacy of currently recommended empirical antibiotic therapy was very low in nosocomial infections (40%), compared to HCA and CA episodes (73% and 83%, respectively; P < 0.0001), particularly in spontaneous bacterial peritonitis, urinary tract infection, and pneumonia (26%, 29%, and 44%, respectively). Septic shock (26% versus 10%; P < 0.0001) and mortality rate (25% versus 12%; P = 0.001) were significantly higher in infections caused by multiresistant strains. Nosocomial origin of infection (hazard ratio [HR], 4.43), long-term norfloxacin prophylaxis (HR, 2.69), recent infection by multiresistant bacteria (HR, 2.45), and recent use of ß-lactams (HR, 2.39) were independently associated with the development of multiresistant infections. Results in the second series were similar to those observed in the first series. CONCLUSIONS: Multiresistant bacteria, especially ESBL-producing Enterobacteriaceae, are frequently isolated in nosocomial and, to a lesser extent, HCA infections in cirrhosis, rendering third-generation cephalosporins clinically ineffective. New antibiotic strategies tailored according to the local epidemiological patterns are needed for the empirical treatment of nosocomial infections in cirrhosis.