Editorial
Benefits of continuous subcutaneous insulin infusion in type 1 diabetes. Is there any doubt?
Beneficios del tratamiento con infusión subcutánea continua de insulina en la diabetes tipo 1. ¿Queda algún lugar para la duda?
María Asunción Martínez-Brocca
Unidad de Gestión Clínica de Endocrinología y Nutrición, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Consejo Superior de Investigaciones Científícas/Universidad de Sevilla, Sevilla, Spain
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Is there any doubt?" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "103" "paginaFinal" => "105" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "María Asunción Martínez-Brocca" "autores" => array:1 [ 0 => array:3 [ "nombre" => "María Asunción" "apellidos" => "Martínez-Brocca" "email" => array:1 [ 0 => "masuncion.martinez.sspa@juntadeandalucia.es" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Unidad de Gestión Clínica de Endocrinología y Nutrición, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Consejo Superior de Investigaciones Científícas/Universidad de Sevilla, Sevilla, Spain" "identificador" => "aff0005" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Beneficios del tratamiento con infusión subcutánea continua de insulina en la diabetes tipo 1. ¿Queda algún lugar para la duda?" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The favorable impact of intensive therapy on cardiovascular risk in patients with type 1 diabetes mellitus (T1DM) is well-known.<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">1</span></a> However, even with adequate control according to current clinical practice guidelines (HbA<span class="elsevierStyleInf">1c</span><span class="elsevierStyleHsp" style=""></span>≤<span class="elsevierStyleHsp" style=""></span>6.9%), cardiovascular mortality in T1DM is two times higher than the mortality seen in the general population after adjusting for socioeconomic and clinical variables.<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">2</span></a> Both the treatment strategies available and HbA<span class="elsevierStyleInf">1c</span> are imperfect elements for achieving and reflecting, respectively, optimum metabolic control, understood as the normalization of blood glucose levels, their variability, and hyperglycemic and hypoglycemic events.</p><p id="par0010" class="elsevierStylePara elsevierViewall">Steineck et al. recently addressed in the <span class="elsevierStyleItalic">British Medical Journal</span> the interesting issue of the impact of the treatment of T1DM with continuous subcutaneous insulin infusion (CSII) or insulin pumps on cardiovascular mortality. For this, they analyzed the rates of cardiovascular and all-cause mortality in 18,168 patients with T1DM included in the Swedish Diabetes Registry monitored for a mean of 6.8 years. A comparison of the cohort on CSII therapy (n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>2441) with the cohort treated with multiple dose insulin (MDI) (n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>15,727) showed a clinically relevant decrease in the risk of death from cardiovascular disease, coronary artery disease, and all-cause mortality favoring CSII.<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">3</span></a> These long-awaited results allow it to be stated that an association exists between CSII and lower cardiovascular mortality in patients with T1DM.</p><p id="par0015" class="elsevierStylePara elsevierViewall">This study has had a considerable clinical impact, but its limitations have also been recognized. The results seen cannot be attributed to the therapy itself, to the clinical management of patients given CSII, or to the diabetes education received. On the other hand, although a cause and effect relationship cannot be established due to the observational design of the study, this potent health outcome is plausible from the pathophysiological viewpoint. Thus, severe hypoglycemia has been shown to be four times less common in patients with T1DM on CSII as compared to MDI, with greater benefits in patients with higher event rates.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">4</span></a> Severe hypoglycemia has been recognized as a risk factor for cardiovascular events, especially in high-risk patients,<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">5,6</span></a> and recently as a risk factor for decreased survival after a cardiovascular event in T1DM.<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">7</span></a> In addition, different meta-analyses have shown that in T1DM, CSII significantly decreases HbA<span class="elsevierStyleInf">1c</span> as compared to MDI, with a mean difference in HbA<span class="elsevierStyleInf">1c</span> ranging from −0.3% to −0.6%;<a class="elsevierStyleCrossRefs" href="#bib0115"><span class="elsevierStyleSup">4,8–11</span></a> it should be noted that this effect is the greater the higher the HbA<span class="elsevierStyleInf">1c</span> level, which makes CSII particularly effective in patients with poorer chronic control and, thus, at a greater risk of secondary complications.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">4</span></a> It has not been elucidated yet whether other favorable effects of CSII, such as decreased glycemic variability, may contribute to decreased cardiovascular mortality.</p><p id="par0020" class="elsevierStylePara elsevierViewall">CSII may be particularly effective in children because it allows for the adaptation to the low insulin requirements and the variable intake and physical activity characteristic of this age group. Thus, data from European and US registries have related CSII therapy to improved metabolic control in this population.<a class="elsevierStyleCrossRefs" href="#bib0155"><span class="elsevierStyleSup">12,13</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">In addition to its clinical benefits, CSII therapy has been shown to be cost-effective in economic evaluation studies conducted in neighboring countries, and also in the Spanish health system.<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">14</span></a> The available evidence warrants the inclusion of CSII in clinical practice guidelines such as those issued by the National Institute for Health and Care Excellence (NICE), which are usually restrictive because they take into consideration not only efficacy criteria, but also cost-effectiveness.<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">15</span></a> Despite this strong evidence, the use of CSII in Spain is surprisingly low and has not substantially increased in recent years. National experts have previously expressed their concern about this situation.<a class="elsevierStyleCrossRefs" href="#bib0175"><span class="elsevierStyleSup">16,17</span></a> Thus, the proportion of Spanish patients with T1DM treated with CSII ranges from 3%–4%,<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">18</span></a> much lower than the 15%–20% reported in countries from North and Central Europe. There is also a worrying variability between the different autonomous communities, and between the different hospitals within the communities, in both pediatric and adult populations. This has resulted in a serious problem of accessibility and of unequal opportunities in our health system. The economic recession in recent years may have contributed to slowing down the introduction of CSII implementation programs, a situation to which the suppliers of this technology have also had to adapt, but this cannot be considered as the main or only cause of this technological gap, which is similar to others that have historically occurred in the care of diabetic patients in Spain. From the organizational viewpoint, the work teams required are not especially complex,<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">17</span></a> but need to be adequately trained, highly motivated and, above all, stable. Institutionally, the existence of CSII programs with evaluable results should be recognized as a quality criterion for the care of patients with T1DM. Above all, it is our own barriers, those of the healthcare professionals, which should be removed in order to overcome this worrying therapeutic inertia, which denies effective and efficient therapy to a significant proportion of our patients. Some of the professionals in charge of patients with T1DM or responsible for their care still underestimate the clinical benefits of therapy both in terms of HbA<span class="elsevierStyleInf">1c</span> reduction and in other metabolic control and quality of life parameters (beyond HbA<span class="elsevierStyleInf">1c</span>), and question its efficiency. This has an impact on CSII expansion, because it affects the most critical issue, the professional confidence which is based on the best scientific knowledge. This represents the true engine of the organization. On the other hand, patient motivation is also recognized as a limiting element, which indeed it is. It is also usually regarded as an intrinsic patient characteristic that we have no possibility of changing. However, with adequate training, CSII improves treatment flexibility and the quality of life of patients, and this is their preferred option also.<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">11</span></a> For these reasons, working in a real environment of shared decision-making with realistic expectations<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">19</span></a> could in many cases overcome our own skepticism and promote in the patient the motivation and implication required by the therapy when clinically indicated.</p><p id="par0030" class="elsevierStylePara elsevierViewall">The clinical benefits of this “new-old” technology in T1DM have already been amply shown, and are confirmed by the associated decrease in mortality. The continued questioning of CSII effectiveness or efficiency as a reason for slowing its implementation is not a scientifically solid argument and also limits the introduction of other advanced technologies to which our patients may have delayed and marginal access. The currently available scientific evidence should be regarded as definitive and lead to its unanimous acceptance by professionals and to resolute institutional action. We should therefore focus on the identification and removal of barriers that limit the expansion of CSII in T1DM in our working environment.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0035" class="elsevierStylePara elsevierViewall">M.A. Martínez-Brocca has participated as an investigator in research projects wholly or partially funded by Medtronic and Roche, and has received fees for papers and participation in work groups funded by Medtronic.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflicts of interest" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Martínez-Brocca MA. Beneficios del tratamiento con infusión subcutánea continua de insulina en la diabetes tipo 1. ¿Queda algún lugar para la duda? Endocrinol Nutr. 2016;63:103–105.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:19 [ 0 => array:3 [ "identificador" => "bib0100" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "D.M. Nathan" 1 => "P.A. Cleary" 2 => "J.Y. Backlund" 3 => "S.M. Genuth" 4 => "J.M. Lachin" 5 => "T.J. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 7 | 1 | 8 |
| 2024 October | 39 | 7 | 46 |
| 2024 September | 54 | 19 | 73 |
| 2024 August | 25 | 3 | 28 |
| 2024 July | 10 | 6 | 16 |
| 2024 June | 14 | 1 | 15 |
| 2024 May | 12 | 1 | 13 |
| 2024 April | 15 | 4 | 19 |
| 2024 March | 28 | 3 | 31 |
| 2024 February | 19 | 1 | 20 |
| 2024 January | 19 | 5 | 24 |
| 2023 December | 24 | 7 | 31 |
| 2023 November | 16 | 5 | 21 |
| 2023 October | 30 | 7 | 37 |
| 2023 September | 13 | 5 | 18 |
| 2023 August | 12 | 2 | 14 |
| 2023 July | 9 | 5 | 14 |
| 2023 June | 20 | 3 | 23 |
| 2023 May | 19 | 6 | 25 |
| 2023 April | 24 | 1 | 25 |
| 2023 March | 19 | 0 | 19 |
| 2023 February | 17 | 3 | 20 |
| 2023 January | 32 | 5 | 37 |
| 2022 December | 21 | 5 | 26 |
| 2022 November | 43 | 15 | 58 |
| 2022 October | 39 | 12 | 51 |
| 2022 September | 20 | 11 | 31 |
| 2022 August | 21 | 10 | 31 |
| 2022 July | 15 | 10 | 25 |
| 2022 June | 18 | 4 | 22 |
| 2022 May | 58 | 9 | 67 |
| 2022 April | 28 | 11 | 39 |
| 2022 March | 28 | 12 | 40 |
| 2022 February | 44 | 11 | 55 |
| 2022 January | 49 | 8 | 57 |
| 2021 December | 44 | 9 | 53 |
| 2021 November | 36 | 14 | 50 |
| 2021 October | 45 | 11 | 56 |
| 2021 September | 18 | 8 | 26 |
| 2021 August | 29 | 11 | 40 |
| 2021 July | 27 | 5 | 32 |
| 2021 June | 27 | 10 | 37 |
| 2021 May | 36 | 11 | 47 |
| 2021 April | 90 | 4 | 94 |
| 2021 March | 67 | 9 | 76 |
| 2021 February | 42 | 10 | 52 |
| 2021 January | 56 | 9 | 65 |
| 2020 December | 38 | 5 | 43 |
| 2020 November | 53 | 8 | 61 |
| 2020 October | 41 | 14 | 55 |
| 2020 September | 33 | 11 | 44 |
| 2020 August | 22 | 8 | 30 |
| 2020 July | 30 | 13 | 43 |
| 2020 June | 21 | 8 | 29 |
| 2020 May | 34 | 6 | 40 |
| 2020 April | 16 | 5 | 21 |
| 2020 March | 28 | 9 | 37 |
| 2020 February | 31 | 6 | 37 |
| 2020 January | 48 | 7 | 55 |
| 2019 December | 43 | 20 | 63 |
| 2019 November | 31 | 3 | 34 |
| 2019 October | 30 | 9 | 39 |
| 2019 September | 34 | 16 | 50 |
| 2019 August | 23 | 1 | 24 |
| 2019 July | 26 | 13 | 39 |
| 2019 June | 34 | 24 | 58 |
| 2019 May | 78 | 28 | 106 |
| 2019 April | 45 | 23 | 68 |
| 2019 March | 18 | 2 | 20 |
| 2019 February | 19 | 5 | 24 |
| 2019 January | 21 | 8 | 29 |
| 2018 December | 12 | 10 | 22 |
| 2018 November | 14 | 0 | 14 |
| 2018 October | 15 | 4 | 19 |
| 2018 September | 7 | 3 | 10 |
| 2018 August | 4 | 0 | 4 |
| 2018 July | 6 | 0 | 6 |
| 2018 June | 14 | 1 | 15 |
| 2018 May | 8 | 0 | 8 |
| 2018 April | 7 | 1 | 8 |
| 2018 March | 6 | 1 | 7 |
| 2018 February | 10 | 0 | 10 |
| 2018 January | 14 | 1 | 15 |
| 2017 December | 12 | 0 | 12 |
| 2017 November | 11 | 0 | 11 |
| 2017 October | 16 | 3 | 19 |
| 2017 September | 14 | 3 | 17 |
| 2017 August | 17 | 1 | 18 |
| 2017 July | 6 | 1 | 7 |
| 2017 June | 17 | 14 | 31 |
| 2017 May | 25 | 5 | 30 |
| 2017 April | 24 | 15 | 39 |
| 2017 March | 48 | 51 | 99 |
| 2017 February | 38 | 5 | 43 |
| 2017 January | 7 | 3 | 10 |
| 2016 December | 12 | 6 | 18 |
| 2016 November | 22 | 6 | 28 |
| 2016 October | 50 | 8 | 58 |
| 2016 September | 26 | 4 | 30 |
| 2016 August | 1 | 2 | 3 |
| 2016 June | 0 | 1 | 1 |
| 2016 April | 0 | 1 | 1 |
| 2016 March | 1 | 0 | 1 |
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