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Transition of continuous subcutaneous insulin infusion systems in a very short time frame as a consequence of a public tender process
Recambio de dispositivos de infusión subcutánea continua de insulina en un periodo breve en el contexto de un concurso público
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What is really useful under the term telemedicine?" ] ] "contieneResumen" => array:2 [ "es" => true "en" => true ] "contieneTextoCompleto" => array:1 [ "es" => true ] "contienePdf" => array:1 [ "es" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figura 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1778 "Ancho" => 2333 "Tamanyo" => 368280 ] ] "descripcion" => array:1 [ "es" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">«The self-management bycicle».</p> <p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Adaptación de Montori y Smith<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a>.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Daria Roca-Espino, Aida Orois-Añón" "autores" => array:2 [ 0 => array:2 [ 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"etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff1" ] ] ] 6 => array:3 [ "nombre" => "Irene" "apellidos" => "Vinagre" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff1" ] ] ] 7 => array:4 [ "nombre" => "Ignacio" "apellidos" => "Conget" "email" => array:1 [ 0 => "iconget@clinic.ub.es" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff1" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic i Universitari, Barcelona, Spain" "etiqueta" => "a" "identificador" => "aff1" ] 1 => array:3 [ "entidad" => "Medtronic Ibérica S.A., Madrid, Spain" "etiqueta" => "b" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Recambio de dispositivos de infusión subcutánea continua de insulina en un periodo breve en el contexto de un concurso público" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 778 "Ancho" => 1567 "Tamanyo" => 48168 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Percentage of patients transferred during the procedure.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Continuous subcutaneous insulin infusion (CSII), also known as insulin pump therapy, represents an alternative to multiple doses of insulin (MDI) when this conventional intensive insulin therapy is unable to achieve the major metabolic goals of type 1 diabetes (T1D) treatment, HbA<span class="elsevierStyleInf">1c</span> as close as possible to normal levels without an unacceptable incidence of hypoglycemia.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Thus far, meta-analyses indicate that CSII has demonstrated beneficial effects in reducing the number of episodes of severe hypoglycemia, as well as, diminishing HbA<span class="elsevierStyleInf">1c</span> by 0.3–1.2% depending on the meta-analysis.<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2–4</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">There is a huge difference in cost between MDI and CSII therapies. Data regarding the cost-effectiveness of CSII compared with MDI in the delivery of intensive insulin therapy for the treatment of T1D, although positive, are still scarce.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> In this context, national health services and centers that provide CSII therapy employ specific guidelines and indications, including the most suitable target groups of subjects, to sustain the cost of CSII therapy implementation. In addition to this, they may consider procuring pump therapy through a tender process that involves various manufacturers of insulin pump devices.<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1,6–8</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">We aimed to describe the feasibility and safety of the transition from one CSII device to another in a very short time frame as the consequence of a public tender.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Materials and methods</span><p id="par0020" class="elsevierStylePara elsevierViewall">The tender was performed following the local regulatory requirements and all the patients using CSII received information about it. After the resolution of the tender and previously to the start of the transition process, all patients were fully informed about the procedure by the medical team.</p><p id="par0025" class="elsevierStylePara elsevierViewall">The CSII replacement process was based on three main pillars: a properly coordinated human team, a structured and specific training program and a procedure result assessment. The human team was composed of a training group (Medtronic qualified technical personnel), a logistical team (Medtronic) and a medical team (Diabetes Unit, Endocrinology and Nutrition Department, University Hospital Clinic of Barcelona). During the entire procedure, 24<span class="elsevierStyleHsp" style=""></span>h technical (Medtronic) and medical support (Diabetes Unit, Endocrinology and Nutrition Department, University Hospital Clinic of Barcelona) was available. The transition had to be performed in a very short time frame (≤1 month).</p><p id="par0030" class="elsevierStylePara elsevierViewall">A specific training program was designed and proposed by Medtronic and carefully supervised by the medical team. The program was organized in modules and adapted to the necessities of each group of patients. The program was composed of three sessions: Session 1 was a system start-up training session, including customized educational contents of the Medtronic Paradigm<span class="elsevierStyleSup">®</span> Veo 754™ (Medtronic MiniMed, Inc., Northridge, CA) and new infusion sets for each patient group (4 individuals per group). Educational material was also provided to each patient (Insulin Pump Guide for Patients, clinical video, and telephone contact instructions for technical assistance). Patient satisfaction was evaluated at the end of the initial training session using a 10-point Likert-type questionnaire, with a score of 10 indicating strong agreement and greatest satisfaction. We used documentation for implementation and tracking of training sessions that was specifically designed for this project. It included a patient's data release form, session checklist, session contents guide, incident registry, and visiting schedule. Session 2 consisted of a call from technical staff 72<span class="elsevierStyleHsp" style=""></span>h after Session 1 to provide support and solve any problems regarding the programming or the infusion set change. Session 3 was a training session regarding the use of CareLink<span class="elsevierStyleSup">®</span> Personal Therapy Management Software for Diabetes (Medtronic MiniMed, Inc., Northridge, CA). This software allows information stored in insulin pumps, continuous glucose monitoring devices, and blood glucose meters to be uploaded and analyzed retrospectively by patients and health care professionals. During this session, patients’ doubts and requests were resolved, and previous training on the new device was reinforced. Sessions included groups of 20 patients and were performed 3 months after Session 2.</p><p id="par0035" class="elsevierStylePara elsevierViewall">During and 2 months after finishing Session 2, three types of incidents were registered: clinical events, technical issues, and training reinforcement incidents. Clinical events were classified as mild (medical assistance was not required), moderate (medical assistance was needed) or severe (hospitalization was required). HbA<span class="elsevierStyleInf">1c</span> data were collected retrospectively, before (closest value in the previous 3 months) and after (closest value after finishing Session 2, performed at least 4 months later) the training program.</p><p id="par0040" class="elsevierStylePara elsevierViewall">Results are presented as means<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>SD or percentages. Comparisons between means, if necessary, were performed using Student's paired <span class="elsevierStyleItalic">t</span>-test. A <span class="elsevierStyleItalic">p</span>-value <0.05 was considered statistically significant. All statistical calculations were performed using the Statistical Package for Social Science (SPSS, version 10.0) for personal computers.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0045" class="elsevierStylePara elsevierViewall">In total, 219 patients were enrolled in the transition process. Baseline characteristics are described in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>. Concerning the previous device, 58 patients had been using an Accu-Chek Spirit (Roche, Roche Diagnostics, Deutschland GmbH, Mannheim, Germany), 67 had been using an Animas 2020 (Animas Corporation, West Chester, PA, US), and 94 subjects had been using the Accu-Chek Combo System (Roche, Roche Diagnostics, Deutschland GmbH, Mannheim, Germany). During the second week of the procedure, 81% of patients were transferred to the new device. This figure rose to 99% after 4 weeks (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). Patients’ overall satisfaction with the training process scored 9.4 out of 10.0 (85% scored >8, none scored <7).</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0050" class="elsevierStylePara elsevierViewall">Concerning the different incident types described previously, there were 68 events in total. Thirty episodes were classified as training reinforcement, and seven were classified as technical issues. All 37 were sorted out over the telephone. There were 31 clinical events during the transition period, all related to infusion set issues. Twenty-four were considered mild, and were solved by technical personnel using telephone support. Medical assistance was needed in six events (five unexpected hyperglycemia, and one ketosis episode); three of these occurred in the same patient. We performed a specific training reinforcement in infusion set management for this patient. There was only a single severe clinical event, which presented as ketoacidosis requiring hospitalization. In this case, the patient recognized persistent hyperglycemia at home (12<span class="elsevierStyleHsp" style=""></span>h) that did not respond to repeated pump boluses, and was admitted at the hospital and treated using intravenous insulin and fluid replacement. This event was related to kinking on insertion of the cannula which was not recognized by the patient.</p><p id="par0055" class="elsevierStylePara elsevierViewall">Data were available before and after the transition procedure for 109 patients that were clinically non-significantly different from the whole group (age 46.9<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>11.1 years, 68% women, duration of T1D 26.3<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>9.9 years, on CSII therapy for 7.4<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>4.4 years). Metabolic control improved during the transition process (7.9<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>0.9 before vs. 7.4<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>0.7 after, <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.001).</p><p id="par0060" class="elsevierStylePara elsevierViewall">Three months after the initiation of the procedure, 128 patients attended the CareLink personal therapy management software training. Among the reasons explaining the absence of 91 patients from the training process were: medical staff did not consider it necessary, unsolved changes in contact details, and personal unavailability.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discussion</span><p id="par0065" class="elsevierStylePara elsevierViewall">We were able to perform the transition of a large population of patients with T1D from previous CSII systems to a new one in the context of a public tender safely and in a very short time using a specific training program.</p><p id="par0070" class="elsevierStylePara elsevierViewall">In 2008, the U.K. National Institute for Health and Care Excellence (NICE) considered that, the use of CSII by patients with T1D is associated with reductions in severe hypoglycemia and HbA1c compared with conventional MDI therapy.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> CSII therapy should be considered a treatment option for adults and children with T1D when attempts to achieve target HbA1c levels with MDI have resulted in a disabling rate of hypoglycemia or when HbA1c levels have remained ≥8.5%. Despite these evidence-based recommendations, the use of CSII therapy is still disparate in Europe. Insulin pumps are used by 15–20% of T1D patients in some Nordic, Central, and Western countries; in other European countries, close to or <5% of patients are treated using CSII.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Although the vast majority of western European countries have been well covered by full reimbursement for >10 years, pump penetration remains significantly heterogeneous among some of them. In addition to other more country-specific factors that explain differences in CSII therapy penetration, cost effectiveness issues and the economic situation of each nation's healthcare insurance systems, health institutions, and providers also matter.</p><p id="par0075" class="elsevierStylePara elsevierViewall">In this context, we evaluated the possibility and intention to procure pumps for our CSII program through a public tender process. Scrupulously following the local regulatory requirements, a tender was designed to obtain the best possible cost meeting the needs of our program with regard to quality, quantity, time, and location. As a result of the tender process and because we were using different brands of pumps, more than 200 patients switched from their previous pump model to the new one. Even though the transition process was completed in <30 days, the number of significant clinical events (particularly those related to relevant clinical episodes) could be considered small. All events related to relevant clinical episodes, including the only clinically severe event, were related to infusion set issues, and three of these occurred in the same patient. Thus, in our opinion, the transition could be performed safely and in a very short time with the help of a specific training program for that purpose.</p><p id="par0080" class="elsevierStylePara elsevierViewall">Concerning the course of glycemic control after switching to a new pump model, there was a positive impact in HbA<span class="elsevierStyleInf">1c</span> in the subgroup of patients with available data. The improvement in HbA<span class="elsevierStyleInf">1c</span> was probably related to increased contact with technical staff and education management regarding pump therapy.</p><p id="par0085" class="elsevierStylePara elsevierViewall">Despite the large number of patients, our study has several limitations. The most relevant one to be addressed is that our tender process and the transition program have been designed and performed locally, and it would be highly speculative to extrapolate the same rate of success to other particular settings. Information from studies that include data after a transition from a previous CSII device to a new system in large populations is very scarce.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> At the time of this writing, we are unaware of any study similar to ours, and this precludes any possible comparison.</p><p id="par0090" class="elsevierStylePara elsevierViewall">In conclusion, with the assistance of a specific training program, we were able to complete the switch to a new insulin pump in a large population of patients with T1D in the context of a public tender in a very short time, safely and without deterioration of metabolic control.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Ethical disclosures</span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Protection of human and animal subjects</span><p id="par0095" class="elsevierStylePara elsevierViewall">The authors declare that the procedures followed were in accordance with the regulations of the relevant clinical research ethics committee and with those of the Code of Ethics of the World Medical Association (Declaration of Helsinki).</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Confidentiality of data</span><p id="par0100" class="elsevierStylePara elsevierViewall">The authors declare that they have followed the protocols of their work center on the publication of patient data.</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Right to privacy and informed consent</span><p id="par0105" class="elsevierStylePara elsevierViewall">The authors have obtained the written informed consent of the patients or subjects mentioned in the article. The corresponding author is in possession of this document.</p></span></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Conflicts of interest</span><p id="par0120" class="elsevierStylePara elsevierViewall">PR, MG, IV and IC declare no conflict of interest. NC, OM, MM and SI are Medtronic employees.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:12 [ 0 => array:3 [ "identificador" => "xres439154" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Aim" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec462286" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres439155" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Pacientes y métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec462285" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Materials and methods" ] 6 => array:2 [ "identificador" => "sec0015" "titulo" => "Results" ] 7 => array:2 [ "identificador" => "sec0020" "titulo" => "Discussion" ] 8 => array:3 [ "identificador" => "sec0025" "titulo" => "Ethical disclosures" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0030" "titulo" => "Protection of human and animal subjects" ] 1 => array:2 [ "identificador" => "sec0035" "titulo" => "Confidentiality of data" ] 2 => array:2 [ "identificador" => "sec0040" "titulo" => "Right to privacy and informed consent" ] ] ] 9 => array:2 [ "identificador" => "sec0065" "titulo" => "Conflicts of interest" ] 10 => array:2 [ "identificador" => "xack131738" "titulo" => "Acknowledgments" ] 11 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2014-09-25" "fechaAceptado" => "2014-10-23" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec462286" "palabras" => array:3 [ 0 => "Continuous subcutaneous insulin infusion systems" 1 => "Type 1 Diabetes transition" 2 => "Public tender" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec462285" "palabras" => array:4 [ 0 => "Infusión subcutánea continua de insulina" 1 => "Diabetes mellitus tipo 1" 2 => "Recambio" 3 => "Concurso público" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Aim</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The procurement of pumps/supplies through a tender process is common practice among public services. A report is presented on the feasibility and safety of the transition from one continuous subcutaneous insulin infusion (CSII) system to another within a very short time frame (4-weeks) as the consequence of a public tender.</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">The program consisted of: Session-1 was a system start-up training session. Patient satisfaction was evaluated. Session-2 consisted of a call from technical staff 72<span class="elsevierStyleHsp" style=""></span>h after Session-1 to provide support regarding the programming or the change of infusion set. Session-3 was a training session regarding the use of therapy management software. During and 2 months after Session-2, clinical events, technical issues, and training reinforcement incidents were registered. HbA1c data were collected retrospectively.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">A total of 219 patients were enrolled. During the second week, 81% of patients were transferred to the new system. Patient overall satisfaction scored 9.4/10 (none <7). There were 30 training reinforcement events and 7 technical issues, with all 37 of them being were sorted out over the telephone. There were 31 additional clinical events (infusion set issues). Twenty-four were considered mild, and were solved by phone technical support. Medical assistance was needed in six (five unexpected hyperglycemia, one ketosis). There was only one severe event (ketoacidosis requiring hospitalization). HbA1c did not deteriorate during the transition process. One hundred twenty-eight patients attended the therapy management software training.</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">With the assistance of a specific program, a complete switch to a new insulin pump in a large population of patients with T1D in the context of a public tender in a very short time was carried out safely and without deterioration of metabolic control.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Aim" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducción</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">El sistema público de salud financia la utilización de infusores subcutáneos de insulina (ISCI) como tratamiento no convencional en pacientes con diabetes mellitus tipo 1 (DT1). En este contexto, y con el fin de mejorar la eficiencia, es frecuente que los centros encargados de este tipo de terapia utilicen procedimientos de licitación. Nuestro objetivo fue evaluar la eficacia y la seguridad de un proceso de recambio de dispositivos ISCI a llevar a cabo en un breve periodo (4 semanas) en un procedimiento de concurso público.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Pacientes y métodos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">El proceso de recambio incluyó 3 sesiones precedidas por la presentación y la justificación del mismo: sesión 1: adiestramiento en la utilización del nuevo dispositivo ISCI y administración de una encuesta de satisfacción; sesión 2: contacto telefónico de soporte a las 72 h de iniciado el programa a la búsqueda de incidencias, y sesión 3: a los 3 meses, sesión de refuerzo/consolidación de los conocimientos y adiestramiento en el uso de programa informático de gestión del tratamiento. Durante 2 meses se recogieron todas las incidencias clínicas y técnicas. Retrospectivamente, se obtuvo la HbA1c más cercana al inicio y la primera una vez finalizado el programa.</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se efectuó el recambio en 219 pacientes, el 81% de los recambios se efectuó en las 2 primeras semanas. En la encuesta de satisfacción realizada se obtuvo una puntuación media de 9,4 sobre 10. Se efectuaron un total de 30 llamadas telefónicas extra con el fin de reforzar aspectos educativos y en 7 ocasiones se atendieron incidencias técnicas que fueron resueltas de manera inmediata. Veinticuatro de 31 eventos clínicos registrados fueron considerados de carácter leve. Seis de ellos fueron moderados (5 hiperglucemias simples/1 cetosis). Un evento fue catalogado como grave (cetoacidosis diabética). Todos los eventos se relacionaron con el equipo de infusión (recambio) y en todos se resolvieron de manera satisfactoria. La HbA1c tras el recambio no cambió significativamente. Ciento veintiocho pacientes acudieron al adiestramiento en el uso del programa informático de gestión del tratamiento.</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">En el contexto de un proceso de licitación y bajo un programa diseñado específicamente, el recambio de dispositivos ISCI puede realizarse de manera segura y sin deterioro alguno en el control metabólico en un considerable número de pacientes y en un corto periodo.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Pacientes y métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] ] "multimedia" => array:2 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 778 "Ancho" => 1567 "Tamanyo" => 48168 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Percentage of patients transferred during the procedure.</p>" ] ] 1 => array:7 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:2 [ "leyenda" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Values are presented as mean<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>SD, unless stated otherwise.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black"><span class="elsevierStyleItalic">N</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>219 \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Age (years) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">45.1<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>11.2 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Sex <span class="elsevierStyleItalic">n</span> (%), women \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">64% \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Duration of diabetes (years) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">25.2<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>9.7 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">On CSII therapy (years) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">7.3<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>3.4 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab685604.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Baseline characteristics.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "NICE guidance on continuous subcutaneous insulin infusion 2008: review of the technology appraisal guidance" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "J.C. Pickup" 1 => "P. Hammond" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1111/j.1464-5491.2009.02661.x" "Revista" => array:6 [ "tituloSerie" => "Diabet Med" "fecha" => "2009" "volumen" => "26" "paginaInicial" => "1" "paginaFinal" => "4" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/19284411" "web" => "Medline" ] ] ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0010" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Severe hypoglycaemia and glycaemic control in Type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "J.C. Pickup" 1 => "A.J. Sutton" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1111/j.1464-5491.2008.02486.x" "Revista" => array:6 [ "tituloSerie" => "Diabet Med" "fecha" => "2008" "volumen" => "25" "paginaInicial" => "765" "paginaFinal" => "774" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/18644063" "web" => "Medline" ] ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0015" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Continuous subcutaneous insulin infusion versus multiple daily insulin injections in type 1 diabetes: a meta-analysis" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "M. Monami" 1 => "C. Lamanna" 2 => "N. Marchionni" 3 => "E. 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Hellman" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.4158/EP14145.PS" "Revista" => array:6 [ "tituloSerie" => "Endocr Pract" "fecha" => "2014" "volumen" => "20" "paginaInicial" => "463" "paginaFinal" => "489" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/24816754" "web" => "Medline" ] ] ] ] ] ] ] ] 7 => array:3 [ "identificador" => "bib0040" "etiqueta" => "8" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "The U.K. service level audit of insulin pump therapy in adults" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "H.D. White" 1 => "N. Goenka" 2 => "N.J. Furlong" 3 => "S. Saunders" 4 => "G. Morrison" 5 => "P. Langridge" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1111/dme.12325" "Revista" => array:6 [ "tituloSerie" => "Diabet Med" "fecha" => "2014" "volumen" => "31" "paginaInicial" => "412" "paginaFinal" => "418" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/24117515" "web" => "Medline" ] ] ] ] ] ] ] ] 8 => array:3 [ "identificador" => "bib0045" "etiqueta" => "9" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Insulin pump use in Europe" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "E. Renard" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1089/dia.2009.0189" "Revista" => array:7 [ "tituloSerie" => "Diabetes Technol Ther" "fecha" => "2010" "volumen" => "12" "numero" => "Suppl. 1" "paginaInicial" => "S29" "paginaFinal" => "S32" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/20515303" "web" => "Medline" ] ] ] ] ] ] ] ] 9 => array:3 [ "identificador" => "bib0050" "etiqueta" => "10" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "ProAct study: new features of insulin pumps improve diabetes management and glycemic control in patients after transition of continuous subcutaneous insulin infusion systems" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "R. Ziegler" 1 => "C. Tubili" 2 => "A. Chico" 3 => "B. Guerci" 4 => "E. Lundberg" 5 => "M. Borchert" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1089/dia.2013.0090" "Revista" => array:6 [ "tituloSerie" => "Diabetes Technol Ther" "fecha" => "2013" "volumen" => "15" "paginaInicial" => "738" "paginaFinal" => "743" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/23931739" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] "agradecimientos" => array:1 [ 0 => array:4 [ "identificador" => "xack131738" "titulo" => "Acknowledgments" "texto" => "<p id="par0110" class="elsevierStylePara elsevierViewall">The authors thank the logistical team (Medtronic) and the medical team (Diabetes Unit, Endocrinology and Nutrition Department, University Hospital Clinic of Barcelona) involved in the transition for their continuous effort throughout the course of the procedure.</p>" "vista" => "all" ] ] ] "idiomaDefecto" => "en" "url" => "/11343230/0000003100000001/v2_201502270306/S1134323014001343/v2_201502270306/en/main.assets" "Apartado" => array:4 [ "identificador" => "7306" "tipo" => "SECCION" "es" => array:2 [ "titulo" => "Artículos originales" "idiomaDefecto" => true ] "idiomaDefecto" => "es" ] "PDF" => "https://static.elsevier.es/multimedia/11343230/0000003100000001/v2_201502270306/S1134323014001343/v2_201502270306/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1134323014001343?idApp=UINPBA00004N" ]
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| 2021 April | 73 | 19 | 92 |
| 2021 March | 33 | 11 | 44 |
| 2021 February | 19 | 5 | 24 |
| 2021 January | 26 | 11 | 37 |
| 2020 December | 22 | 11 | 33 |
| 2020 November | 22 | 3 | 25 |
| 2020 October | 16 | 5 | 21 |
| 2020 September | 19 | 10 | 29 |
| 2020 August | 27 | 5 | 32 |
| 2020 July | 23 | 5 | 28 |
| 2020 June | 20 | 10 | 30 |
| 2020 May | 18 | 8 | 26 |
| 2020 April | 48 | 14 | 62 |
| 2020 March | 25 | 4 | 29 |
| 2020 February | 23 | 8 | 31 |
| 2020 January | 27 | 9 | 36 |
| 2019 December | 28 | 6 | 34 |
| 2019 November | 17 | 7 | 24 |
| 2019 October | 16 | 6 | 22 |
| 2019 September | 22 | 6 | 28 |
| 2019 August | 27 | 1 | 28 |
| 2019 July | 17 | 20 | 37 |
| 2019 June | 45 | 33 | 78 |
| 2019 May | 102 | 57 | 159 |
| 2019 April | 38 | 30 | 68 |
| 2019 March | 9 | 9 | 18 |
| 2019 February | 20 | 3 | 23 |
| 2019 January | 10 | 9 | 19 |
| 2018 December | 15 | 1 | 16 |
| 2018 November | 17 | 4 | 21 |
| 2018 October | 10 | 9 | 19 |
| 2018 September | 8 | 1 | 9 |
| 2018 August | 12 | 0 | 12 |
| 2018 July | 9 | 5 | 14 |
| 2018 June | 8 | 1 | 9 |
| 2018 May | 8 | 6 | 14 |
| 2018 April | 8 | 2 | 10 |
| 2018 March | 7 | 1 | 8 |
| 2018 February | 8 | 2 | 10 |
| 2018 January | 12 | 0 | 12 |
| 2017 December | 6 | 0 | 6 |
| 2017 November | 8 | 0 | 8 |
| 2017 October | 9 | 3 | 12 |
| 2017 September | 12 | 0 | 12 |
| 2017 August | 11 | 0 | 11 |
| 2017 July | 14 | 1 | 15 |
| 2017 June | 26 | 10 | 36 |
| 2017 May | 23 | 6 | 29 |
| 2017 April | 16 | 12 | 28 |
| 2017 March | 17 | 17 | 34 |
| 2017 February | 24 | 0 | 24 |
| 2017 January | 24 | 4 | 28 |
| 2016 December | 56 | 6 | 62 |
| 2016 November | 37 | 4 | 41 |
| 2016 October | 64 | 6 | 70 |
| 2016 September | 49 | 6 | 55 |
| 2016 August | 37 | 4 | 41 |
| 2016 July | 52 | 1 | 53 |
| 2016 June | 45 | 6 | 51 |
| 2016 May | 40 | 11 | 51 |
| 2016 April | 28 | 7 | 35 |
| 2016 March | 18 | 7 | 25 |
| 2016 February | 27 | 10 | 37 |
| 2016 January | 28 | 8 | 36 |
| 2015 November | 1 | 1 | 2 |
| 2015 May | 1 | 2 | 3 |
| 2015 April | 0 | 8 | 8 |
| 2015 March | 1 | 4 | 5 |
| 2015 February | 1 | 1 | 2 |
Show all
