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          "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">HbA1c at baseline&#44; and after 6 and 12 months with MDI and CSII&#46; &#42;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05 basal&#8211;6 month in 2 groups&#59; &#42;&#42;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05 6 month&#8211;12 month in CSII group&#59; &#36;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05 MDI&#47;G vs&#46; CSII 12 month&#46;</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 &#40;CSII&#41; as therapy for patients with type 1 diabetes became available more than 30 years ago&#46;<a class="elsevierStyleCrossRef" href="#bib0215"><span class="elsevierStyleSup">1</span></a> Since then several meta-analyses have reviewed multiple daily injections &#40;MDI&#41; therapy&#44; most with MDI&#47;NPH vs&#46; CSII&#44; discovering greater efficacy in glycaemic control with CSII therapy&#44; in addition to a decrease in the incidence of hypoglycaemic events&#46;<a class="elsevierStyleCrossRefs" href="#bib0220"><span class="elsevierStyleSup">2&#8211;7</span></a> These meta-analyses established CSII therapy as the gold standard for insulin therapy in patients with type 1 diabetes&#46; In addition&#44; the relative benefit of CSII therapy over MDI&#47;NPH is greater at higher baseline HbA1c values&#46;<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">8</span></a> The limitations of MDI&#47;NPH have been alleviated with the introduction of glargine&#44; a long-acting insulin analogue with a flatter and more prolonged time-action profile&#46;<a class="elsevierStyleCrossRef" href="#bib0255"><span class="elsevierStyleSup">9</span></a> Combined with rapid-acting insulin analogues&#44; glargine provides better glycaemic control than intermediate-acting insulin NPH&#44; with no increased risk of hypoglycaemia&#46;<a class="elsevierStyleCrossRefs" href="#bib0260"><span class="elsevierStyleSup">10&#44;11</span></a> The question of whether CSII therapy with ultra-rapid insulin continues to be the gold standard in intensive insulin treatment for type 1 diabetes&#44; however&#44; is still not resolved&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Whereas several authors have found no difference between CSII and MDI with glargine in a variety of end-points&#44; others have found CSII to be superior&#46; Several randomized studies have performed a comparative evaluation of CSII vs&#46; MDI with insulin glargine &#40;MDI&#47;G&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0270"><span class="elsevierStyleSup">12&#8211;17</span></a> In adults&#44; HbA1C results are similar with both treatments&#46; However&#44; in the study by Hirsch et al&#46;<a class="elsevierStyleCrossRef" href="#bib0280"><span class="elsevierStyleSup">14</span></a> the results obtained from the measurement of serum levels of fructosamine and the reduced exposure to hyperglycaemia assessed through continuous glucose monitoring &#40;CGMS&#41; showed better metabolic control with CSII&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Severe hypoglycaemia remains one of the most feared complications&#46;<a class="elsevierStyleCrossRef" href="#bib0300"><span class="elsevierStyleSup">18</span></a> The scientific evidence that CSII therapy reduces the frequency of severe hypoglycaemia compared to MDI&#47;NPH is very strong&#46;<a class="elsevierStyleCrossRef" href="#bib0305"><span class="elsevierStyleSup">19</span></a> Pickup and Keen&#44;<a class="elsevierStyleCrossRef" href="#bib0220"><span class="elsevierStyleSup">2</span></a> in their review&#44; found that the rate of severe hypoglycaemia was four times lower with CSII than with MDI&#44; and the greatest improvements occurred in those patients with higher rates of severe hypoglycaemia when treated with MDI&#46; The frequency of mild hypoglycaemia is also lower with CSII&#44; with a reduction of 75&#37; after switching from MDI&#46;<a class="elsevierStyleCrossRef" href="#bib0310"><span class="elsevierStyleSup">20</span></a> Several studies comparing MDI based on glargine or detemir have found a lower incidence of nocturnal hypoglycaemia than with NPH&#46;<a class="elsevierStyleCrossRef" href="#bib0315"><span class="elsevierStyleSup">21</span></a> On the other hand&#44; studies comparing the incidence of severe hypoglycaemia during CSII and MDI with long-acting analogues have given contrasting results&#44; with some finding no difference<a class="elsevierStyleCrossRefs" href="#bib0280"><span class="elsevierStyleSup">14&#44;15&#44;17</span></a> while others found that patients prone to hypoglycaemia had fewer hypoglycaemic episodes during CSII&#46;<a class="elsevierStyleCrossRef" href="#bib0310"><span class="elsevierStyleSup">20</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Currently there is strong interest in glycaemic variability&#44; due to the possible relationship with microvascular and macrovascular disease&#46;<a class="elsevierStyleCrossRefs" href="#bib0320"><span class="elsevierStyleSup">22&#44;23</span></a> Indeed&#44; glycaemic variability in combination with HbA1c could be a more realistic indicator of glycaemic control and long-term risk of complications than HbA1c alone&#46;<a class="elsevierStyleCrossRefs" href="#bib0330"><span class="elsevierStyleSup">24&#44;25</span></a> Several authors found that glucose variability during CSII was smaller than during MDI&#47;NPH&#46;<a class="elsevierStyleCrossRefs" href="#bib0340"><span class="elsevierStyleSup">26&#44;27</span></a> Other studies have compared the effects on glucose variability of CSII and MDI based on long-acting analogues and have found either no differences&#44; or higher or lower glucose variability<a class="elsevierStyleCrossRefs" href="#bib0270"><span class="elsevierStyleSup">12&#44;14&#44;16&#44;28&#8211;30</span></a> during CSII&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">There are conflicting results concerning the effects of CSII therapy on quality of life&#46; A meta-analysis in 2007 concluded that the effects of CSII on quality of life remain unclear&#46;<a class="elsevierStyleCrossRef" href="#bib0365"><span class="elsevierStyleSup">31</span></a> More recent studies have obtained different results&#44; some finding a better quality of life<a class="elsevierStyleCrossRefs" href="#bib0375"><span class="elsevierStyleSup">15&#44;27&#44;32</span></a> but others seeing a similar quality of life with CSII&#46;<a class="elsevierStyleCrossRef" href="#bib0295"><span class="elsevierStyleSup">17</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">The objectives of this study were to determine&#58; &#40;1&#41; whether CSII is more effective than MDI therapy using insulin analogues &#40;rapid and long&#41; in metabolic control and QOL&#44; and &#40;2&#41; whether CSII therapy has supplemental benefits in patients with type 1 diabetes who are optimized with MDI therapy using insulin analogues&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Materials and methods</span><p id="par0035" class="elsevierStylePara elsevierViewall">This was a randomized&#44; parallel group&#44; open-label study performed in the Diabetes Centre of the Endocrinology and Nutrition Department of Carlos Haya University Hospital in Malaga&#44; Spain&#46;</p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Subjects</span><p id="par0040" class="elsevierStylePara elsevierViewall">Inclusion criteria&#58; patients aged 18&#8211;65 years with type 1 diabetes for more than 5 years&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Exclusion criteria&#58; acute coronary syndrome or stroke in the last 6 months&#44; active proliferative retinopathy&#44; uncontrolled hypertension&#44; severe vegetative neuropathy&#44; impaired hepatic&#47;renal function&#44; prior use of CSII or insulin glargine&#44; patients unable to use CSII or MDI or patients planning pregnancy&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">A total of 45 patients met the inclusion criteria&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The sample size calculation was performed to detect a difference of 1&#46;5&#37; in HbA1c using a standard deviation of 1&#46;2&#44; a <span class="elsevierStyleItalic">&#945;</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;05 &#40;two-tailed&#41;&#44; and a power of 90&#37;&#46; The resulting minimum size was 15 patients per group&#44; including 15&#37; of lost patients&#46; To obtain 30 patients &#40;15 CSII and 15 MDI&#47;G&#41; 45 is selected in case had lost over 15&#37; calculated on the protocol development&#46; The key is the intergroup comparison &#40;CSII vs&#46; MDI&#47;G&#41; and is carried out at 12 months&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">During the first 6 months seven patients were lost&#44; leaving 38 patients&#59; then&#44; without meeting criteria for CSII therapy&#44; these 38 patients were randomized&#44; 15 to CSII and 23 to MDI&#47;G during six months&#44; with no patients lost in this phase&#46; The 7 patients withdrawing of the study at the first phase owed to the inability to follow protocol and monthly visits&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">All the subjects provided written informed consent&#46; The study was performed in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines and with the approval of the Ethics Committee of Carlos Haya University Hospital&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Design</span><p id="par0070" class="elsevierStylePara elsevierViewall">Randomized clinical trial &#40;2 MDI&#47;G&#58; 1 CSII&#41; with a prior homogenization phase with MDI&#47;G&#46;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0075" class="elsevierStylePara elsevierViewall">Phase 1&#58; educational homogenization and adherence&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">Forty-five patients with type 1 diabetes&#44; under treatment with MDI&#47;NPH and rapid analogues&#44; were switched to MDI with glargine as basal insulin and followed-up monthly for 6 months&#46; The patients used insulin lispro &#40;Eli Lilly Inc&#46;&#44; Indianapolis&#44; IN&#41; before each meal and a single dose of glargine&#46; Seven patients dropped out of the study in Phase 1&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0085" class="elsevierStylePara elsevierViewall">Phase 2&#58; randomization&#46; After the first 6 months&#44; from this metabolically optimized group&#44; 15 patients were randomly assigned to CSII therapy&#46; These CSII patients received insulin lispro via a multi-programmable insulin infusion system &#40;Paradigm 712&#44; Medtronic&#44; USA&#41;&#46; 23 patients continued with MDI&#47;G once daily in the evening plus mealtime insulin lispro&#59; both groups completed 6 further months &#40;23 patients MDI&#47;G vs&#46; 15 patients CSII&#41;&#44; with monthly follow-up&#46;</p></li></ul></p><p id="par0090" class="elsevierStylePara elsevierViewall">All the patients developed skills necessary for intensive functional therapy including self-monitoring of blood glucose &#40;SMBG&#41; using a plasma-calibrated memory glucose metre &#40;OneTouch Ultra&#59; Lifescan&#44; Milpitas&#44; CA&#41;&#44; carbohydrate counting&#44; insulin adjustment and technical aspects of the pumps&#46; The glycaemic targets were identical for both treatment groups&#58; glycaemia of 80&#8211;120<span class="elsevierStyleHsp" style=""></span>mg&#47;dl &#40;4&#46;4&#8211;6&#46;6<span class="elsevierStyleHsp" style=""></span>mmol&#47;L&#41; before and &#60;150<span class="elsevierStyleHsp" style=""></span>mg&#47;dl &#40;8&#46;3<span class="elsevierStyleHsp" style=""></span>mmol&#47;L&#41; 2<span class="elsevierStyleHsp" style=""></span>h after meals&#46; Three days of glycaemia monitoring via CGSM &#40;Medtronic&#44; USA&#41; was done at the end of each treatment period and the time spent with blood glucose<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>70<span class="elsevierStyleHsp" style=""></span>mg&#47;dl&#47;3&#46;9<span class="elsevierStyleHsp" style=""></span>mmol&#47;L&#44; &#62;180<span class="elsevierStyleHsp" style=""></span>mg&#47;dl&#47;10<span class="elsevierStyleHsp" style=""></span>mmol&#47;L&#44; and 70&#8211;180<span class="elsevierStyleHsp" style=""></span>mg&#47;dl&#47;3&#46;9&#8211;9&#46;9<span class="elsevierStyleHsp" style=""></span>mmol&#47;L was recorded&#46;<a class="elsevierStyleCrossRef" href="#bib0380"><span class="elsevierStyleSup">33</span></a></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Variables and instruments</span><p id="par0095" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0100" class="elsevierStylePara elsevierViewall">Sociodemographics&#58; sex and age&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#8226;</span><p id="par0105" class="elsevierStylePara elsevierViewall">Anthropometric&#58; weight&#44; BMI&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">&#8226;</span><p id="par0110" class="elsevierStylePara elsevierViewall">Insulin therapy&#58; daily insulin dose &#40;DID&#41; &#40;insulin&#47;kg&#41;&#44; basal insulin dose &#40;&#37;&#41;&#44; bolus insulin dose &#40;&#37;&#41;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">&#8226;</span><p id="par0115" class="elsevierStylePara elsevierViewall">Complications&#58; mild hypoglycaemia &#40;episodes per week&#41;&#44; severe hypoglycaemia &#40;episodes per 6 months&#41; and ketoacidosis episodes&#46; Hypoglycaemia was defined according to the ADA criteria&#46;<a class="elsevierStyleCrossRef" href="#bib0385"><span class="elsevierStyleSup">34</span></a></p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">&#8226;</span><p id="par0120" class="elsevierStylePara elsevierViewall">Metabolic control parameters&#58; HbA1c &#40;HPLC&#59; Diabetes Control and Complications Trial &#91;DCCT&#93; Research Group aligned&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">&#8226;</span><p id="par0125" class="elsevierStylePara elsevierViewall">Glycaemic variability parameters&#58; obtained by standard deviation &#40;SD&#41;&#44; low blood glucose index &#40;LBGI&#41; and high blood glucose index &#40;HBGI&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0390"><span class="elsevierStyleSup">35</span></a> obtained from CGSM&#46;</p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">&#8226;</span><p id="par0130" class="elsevierStylePara elsevierViewall">Quality of life parameters&#58; the quality of life during each treatment phase was measured using a version of the Diabetes Quality of Life &#40;EsDQOL&#41; questionnaire of the DCCT Research Group&#44; adapted to the Spanish population&#46;<a class="elsevierStyleCrossRef" href="#bib0395"><span class="elsevierStyleSup">36</span></a> The scale consists of 43 items that are 4 dimensions&#58; satisfaction with treatment &#40;15 items&#41;&#44; impact of treatment &#40;17 items&#41;&#44; social&#47;vocational concerns &#40;7 items&#41; and concern regarding the future effects of diabetes &#40;4 items&#41;&#46; Each item has 5 possible answers on Likert scoring from 1 to 5&#46; Satisfaction subscale responses to each item ranged from &#8220;very satisfied&#8221; &#40;1 point&#41; to &#8220;not satisfied&#8221; &#40;5 points&#41;&#46; In the other three subscales&#44; responses ranged from &#8220;never&#8221; &#40;1 point&#41; to &#8220;always&#8221; &#40;5 points&#41;&#46; A total score and subscales score can be obtained&#46; A lower score means better quality of life&#46; It is designed to be self-administered&#46;</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">&#8226;</span><p id="par0135" class="elsevierStylePara elsevierViewall">The primary objectives were the HbA1c value at the end of each treatment phase&#44; with a goal of HbA1c &#60;7&#46;5&#37; and the QOL during each phase&#46;</p></li></ul></p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Data analysis and statistics</span><p id="par0140" class="elsevierStylePara elsevierViewall">The data are presented as mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>SD or proportions&#46; At baseline&#44; homogeneity between the randomized sequence groups &#40;CSII and MDI&#47;G&#41; was tested using two-sample unpaired Student&#39;s <span class="elsevierStyleItalic">t</span>-test for normally distributed data&#44; or the Wilcoxon rank sum test for non-normally distributed data&#46; To compare the scores before and after treatment two types of analysis were used&#46; For the variables with scores that adjusted to a normal distribution a repeated measures ANOVA was used&#46; For the variables with scores that did not follow a normal distribution a non-parametric contrast test was used &#40;Wilcoxon test&#41;&#46; For comparison of means the Student <span class="elsevierStyleItalic">t</span> test was used for related or independent samples and the chi-square test was used to determine the association between qualitative variables&#46; Analyses per protocol were done and carried out with SPSS software &#40;18&#46;0 version&#41;&#46; The confidence intervals were set at 95&#37;&#46;</p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Results</span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Baseline data &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 1</a>&#41;</span><p id="par0145" class="elsevierStylePara elsevierViewall">The mean age of patients was 29&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;5 years&#44; 46&#37; were men&#44; the duration of diabetes was 13&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7 years&#44; the mean HbA1c was 8&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;2&#37; &#40;68<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#46;7<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#41;&#44; 33&#37; with &#60;7&#46;5&#37; &#40;58&#46;5<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#41;&#46; The baseline characteristics were similar for both treatment groups&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Phase 1&#58; homogenization &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 2</a>&#41;</span><p id="par0150" class="elsevierStylePara elsevierViewall">Metabolic control&#58; in the first 6 months &#40;MDI&#47;NPH to MDI&#47;glargine&#41; &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>38&#41;&#44; there was an improvement in HbA1c&#44; with a mean decrease of 0&#46;5&#37; &#40;8&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;2&#37; vs&#46; 7&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;7&#37;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;032&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#44; a HbA1c &#60;7&#46;5&#37; was reached by 36&#46;8&#37; of the patients &#40;vs&#46; 33&#37; at baseline&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;7&#41; and the frequency of severe hypoglycaemia declined &#40;0&#46;44<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;9 vs&#46; 0&#46;050<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;2&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;014&#41; with no changes in mild hypoglycaemia&#46; There was an increase in the number of self-analyses per day &#40;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;2 vs&#46; 4&#46;33<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;5&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;0001&#41; and an increase in BMI &#40;25&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3 vs&#46; 25&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;5&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;014&#41;&#46; The total daily insulin decreased 8&#37; &#40;0&#46;87<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;29 vs&#46; 0&#46;80<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;25<span class="elsevierStyleHsp" style=""></span>IU&#47;kg&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;049&#41; and basal insulin decreased 12&#37; &#40;41&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>16&#46;4 vs&#46; 36&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>15&#46;7<span class="elsevierStyleHsp" style=""></span>IU&#47;day&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46; There were no episodes of ketoacidosis in the group&#46; With respect to the CGMS data&#44; there was an increase in periods of normoglycaemia &#40;15&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>11&#37; vs&#46; 23<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18&#46;4&#37;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;03&#41; and a significant improvement in glycaemic variability measured by the SD of CGMS &#40;66&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>14 vs&#46; 59&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>16&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05&#41;&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0155" class="elsevierStylePara elsevierViewall">Quality of life&#58; significant changes were perceived in the overall EsDQOL &#40;99&#46;72<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18&#46;38 vs&#46; 92&#46;07<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>17&#46;65&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;007&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41; and an improvement in the subscale &#8220;satisfaction with treatment&#8221; &#40;39&#46;15<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;54 vs&#46; 35&#46;45<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#46;46&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;01&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Phase 2&#58; after randomization &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 2</a>&#41;</span><p id="par0160" class="elsevierStylePara elsevierViewall">Metabolic control&#58; In the CSII group&#44; after 6 months HbA1c values decreased significantly &#40;7&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;7&#37; &#91;63<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;5<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#93; to 7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;6&#37; &#91;53<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;5&#93;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;00&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#44; with 67&#37; of patients achieving the objective of 7&#46;5&#37; &#40;vs&#46; 6<span class="elsevierStyleHsp" style=""></span>m&#58; 36&#46;8&#37;&#41; &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;5&#41;&#46; There was an improvement in time in normoglycaemia &#40;23<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18&#46;4 vs&#46; 50<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;6&#37;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;002&#41;&#44; time in hyperglycaemia &#40;69&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>21&#46;5 vs&#46; 42&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>12&#37;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;02&#41; and HBGI &#40;CGMS&#41; &#40;8&#46;1<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;5 vs&#46; 5&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;3&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;045&#41;&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">In the MDI&#47;G group&#44; no significant change was seen in HbA1c &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46; In CGMS&#44; decreases were seen in mean glycaemia &#40;162<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>30<span class="elsevierStyleHsp" style=""></span>mg&#47;dl vs&#46; 146&#46;78<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>36&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;04&#41;&#44; and time in hyperglycaemia &#40;69&#46;38<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>43&#46;16 vs&#46; 43<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>16&#46;2&#37;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;01&#41; and an increase in time in normoglycaemia &#40;23<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18&#46;4 vs&#46; 50&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18&#37;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;01&#41;&#46;</p><p id="par0170" class="elsevierStylePara elsevierViewall">Although a tendency towards better control parameters was seen in the metabolic variables evaluated in the two groups&#44; significantly lower levels of HbA1c were only seen in the CSII group compared with the MDI&#47;G group &#40;MDI&#47;G 7&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;9 vs&#46; CSII 7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;6&#37;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;03&#41;&#44; with a higher number of self-tests per day in the CSII group compared to the MDI&#47;G group&#58; 4&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;6 vs&#46; 3&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;5 &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;008&#41;&#46; There is a positive correlation in the set of the 38 patients at 12 months between the number of SMBG and reached HbA1c &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#8722;0&#46;45&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;005&#46;&#41; which does not occur in each group independently &#40;MDI&#47;G <span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;3&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;13&#59; CSII <span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;4&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;14&#41;&#46;</p><p id="par0175" class="elsevierStylePara elsevierViewall">No changes were seen in BMI&#44; insulin dose&#44; mild or severe hypoglycaemia or episodes of ketosis or ketoacidosis in the two groups&#46;</p><p id="par0180" class="elsevierStylePara elsevierViewall">Quality of life&#58; the total DQOL score decreased significantly in the CSII group &#40;91&#46;66<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>22 to 84&#46;53<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;63&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;045&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46; The differences between groups &#40;CSII vs&#46; MDI&#47;G&#41; in absolute scores for total DQOL and the subscales were not significant&#46;</p><p id="par0185" class="elsevierStylePara elsevierViewall">There were no serious adverse events during the study&#46;</p></span></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Discussion</span><p id="par0190" class="elsevierStylePara elsevierViewall">For many years&#44; the advantages of CSII therapy made it a superior treatment compared with MDI&#47;NPH&#46; The incorporation of the long-acting analogues glargine and detemir&#44; soluble insulins with a more predictable absorption&#44; more stable blood levels and with the possibility of improving glycaemic control&#44; have now raised the question of whether these new insulins can replace the need for CSII in people with type 1 diabetes&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">The factors that have an impact on metabolic improvements associated with CSII therapy are still poorly known&#46; Dependency upon pre-CSII results after switching could help to explain the discrepancies regarding the efficacy of the prior studies comparing MDI and CSII&#46; In our study the sample was metabolically optimized during the first 6 months with MDI&#47;G&#44; with the aim of later comparing both therapeutic options randomly&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">Sufficient scientific evidence exists to assert that CSII therapy is superior to MDI&#47;NPH in addressing three problems&#58; &#40;1&#41; elevated HbA1c&#59; &#40;2&#41; repetitive severe hypoglycaemia and &#40;3&#41; glycaemic fluctuations&#46;<a class="elsevierStyleCrossRef" href="#bib0400"><span class="elsevierStyleSup">37</span></a> However&#44; what is the situation with MDI&#47;G&#63;</p><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Metabolic control</span><p id="par0205" class="elsevierStylePara elsevierViewall">Combined with rapid-acting insulin analogues&#44; glargine provides better glycaemic control than NPH&#44; without increasing the risk of hypoglycaemia&#46;<a class="elsevierStyleCrossRefs" href="#bib0260"><span class="elsevierStyleSup">10&#44;11</span></a> Our findings are in agreement with these previous publications&#46; In the first 6 months we detected a significant change in HbA1c upon switching from MDI&#47;NPH to MDI&#47;G&#44; with a significant increase in periods of normoglycaemia and SD&#44; and a significant decrease in episodes of severe hypoglycemia&#46; We also found a significant increase in the number of self-tests per day due to the intensification of the insulin treatment with structured re-education and monthly visits&#46; There was a decrease in daily total and basal insulin and an increase in BMI&#44; probably in relation to the overall metabolic improvement&#46;</p><p id="par0210" class="elsevierStylePara elsevierViewall">A systematic review published in 2012 of randomized studies<a class="elsevierStyleCrossRef" href="#bib0405"><span class="elsevierStyleSup">38</span></a> concluded that CSII provides better HbA1c than MDI&#44; with a low level of evidence&#46; Some of these studies performed a comparative evaluation of CSII vs&#46; MDI with insulin glargine &#40;MDI&#47;G&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0270"><span class="elsevierStyleSup">12&#8211;17</span></a> However&#44; only two randomized studies&#44; one in adolescents<a class="elsevierStyleCrossRef" href="#bib0270"><span class="elsevierStyleSup">12</span></a> and the other in adults&#44;<a class="elsevierStyleCrossRef" href="#bib0280"><span class="elsevierStyleSup">14</span></a> although of short duration&#44; were able to confirm that CSII therapy may improve glycaemic control when compared to MDI with analogues&#46; Doyle et al&#46;<a class="elsevierStyleCrossRef" href="#bib0270"><span class="elsevierStyleSup">12</span></a> randomized 32 adolescents with type 1 diabetes to MDI&#47;G or CSII for 16 weeks and reported a decrease in HbA1c in the CSII group&#46; Hirsch et al&#46;<a class="elsevierStyleCrossRef" href="#bib0280"><span class="elsevierStyleSup">14</span></a> randomized 100 patients with type 1 diabetes to MDI&#47;G or CSII for 5 weeks and demonstrated both a decrease in fructosamine as well as a decrease in the area under the glucose curve using CGMS&#46; In our study&#44; the CSII group achieved better HbA1c than the MDI&#47;G group after 6 months&#44; but no differences were found in the other variables&#46;</p><p id="par0215" class="elsevierStylePara elsevierViewall">To the best of our knowledge&#44; this is the first randomized study in adult patients to report better HbA1c with CSII therapy vs&#46; MDI&#47;G in a maximally optimized adult group and with a prolonged follow-up of 6 months&#46;</p><p id="par0220" class="elsevierStylePara elsevierViewall">In a recent paper derived of the large database of the T1D Exchange clinic registry&#44; Miller et al&#46;<a class="elsevierStyleCrossRef" href="#bib0410"><span class="elsevierStyleSup">39</span></a> communicate that a higher number of SMBG measurements per day were associated with non-Hispanic white race&#44; insurance coverage&#44; higher household income&#44; and use of an insulin pump for insulin delivery &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001 for each factor&#41;&#46; After adjusting for these factors&#44; a higher number of SMBG measurements per day was strongly associated with a lower HbA<span class="elsevierStyleInf">1c</span>&#160;level &#40;adjusted&#160;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#44; with the association being present in all age-groups and in both insulin pump and injection users&#46;</p><p id="par0225" class="elsevierStylePara elsevierViewall">Was there an association between the frequency of SMBG and changes in HbA1c in our study&#63; In this study the frequency and timing of SMBG measurements for study purposes with a structured SMBG regimen was used&#46; Patients in the intensive MDI&#47;G treatment made an average 3&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;4&#47;day while the demands of CSII therapy are always greater and patients CSII group made an average of 4&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;7&#44; thus we cannot rule out that the differences in the two groups of intensive insulin treatment relates to the number of different daily self-analysis performed and better treatment settings&#46; This may be part of the advantages of this intensive treatment&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Hypoglycaemia</span><p id="par0230" class="elsevierStylePara elsevierViewall">As very strong evidence exists that CSII therapy reduces the frequency of severe hypoglycaemia compared with MDI&#47;NPH therapy&#44; this clinical problem is the main indication in many countries&#46;<a class="elsevierStyleCrossRef" href="#bib0305"><span class="elsevierStyleSup">19</span></a> Pickup and Keen<a class="elsevierStyleCrossRef" href="#bib0220"><span class="elsevierStyleSup">2</span></a>&#44; in their meta-analysis&#44; found that the rate of severe hypoglycaemia was four times lower with CSII than with MDI&#44; and the greatest improvements occurred in those patients with higher rates of severe hypoglycaemia when treated with MDI&#46; Long-acting analogues&#44; however&#44; with their improved predictability and flatter absorption profile can lower the frequency of hypoglycaemia&#46;<a class="elsevierStyleCrossRef" href="#bib0315"><span class="elsevierStyleSup">21</span></a> In fact&#44; these functional strategies must be used and explored in patients with poor metabolic control before initiating CSII treatment&#46; Our study confirms this because we reported a significant decrease in severe hypoglycaemia after switching from MDI&#47;NPH to MDI&#47;G&#46; Studies comparing the incidence of severe hypoglycaemia during CSII and MDI based on short- and long-acting analogues have given contrasting results&#44; some finding no difference<a class="elsevierStyleCrossRefs" href="#bib0280"><span class="elsevierStyleSup">14&#44;15&#44;17</span></a> while others found that patients prone to hypoglycaemia had fewer hypoglycaemic episodes during CSII&#46;<a class="elsevierStyleCrossRef" href="#bib0310"><span class="elsevierStyleSup">20</span></a> In our study&#44; no significant differences in episodes of severe hypoglycaemia were found between the MDI&#47;G group and the CSII group&#44; and no significant changes were seen in mild hypoglycaemia in either treatment phase&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Glycaemic variability</span><p id="par0235" class="elsevierStylePara elsevierViewall">Glycaemic variability is included as an indication for treatment with CSII in some references<a class="elsevierStyleCrossRef" href="#bib0415"><span class="elsevierStyleSup">40</span></a> but not in others&#46;<a class="elsevierStyleCrossRef" href="#bib0305"><span class="elsevierStyleSup">19</span></a> CSII should control glucose variability better than any MDI regimen&#44; because during CSII the basal rate of insulin administration can be adjusted continuously and because the constant delivery of small amounts of insulin should minimize glucose oscillations&#46;</p><p id="par0240" class="elsevierStylePara elsevierViewall">Several authors have found that glucose variability during CSII was smaller than during MDI with NPH&#46;<a class="elsevierStyleCrossRefs" href="#bib0340"><span class="elsevierStyleSup">26&#44;27</span></a> On the other hand&#44; other studies have compared the effects on glucose variability of CSII and MDI based on long-acting analogues and have found either no difference&#44; or higher or lower glucose variability during CSII&#46;<a class="elsevierStyleCrossRefs" href="#bib0270"><span class="elsevierStyleSup">12&#44;14&#44;16&#44;29&#44;30</span></a> It should be noted&#44; however&#44; that the studies differed for patient selection&#44; degree of metabolic control at study entry and the methods used to measure variability&#46; A few studies have investigated this aspect using continuous glucose monitoring systems&#44; but with differing results&#46;<a class="elsevierStyleCrossRefs" href="#bib0290"><span class="elsevierStyleSup">16&#44;29&#44;30</span></a> Some found more variability with CSII<a class="elsevierStyleCrossRef" href="#bib0355"><span class="elsevierStyleSup">29</span></a> but others concluded that glucose variability was lower in CSII when glucose control was good &#40;HbA1C<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>7&#46;5&#37;&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0290"><span class="elsevierStyleSup">16&#44;30</span></a> Clearly&#44; more work is needed on this important subject&#46;</p><p id="par0245" class="elsevierStylePara elsevierViewall">In the present study&#44; the variables of glucose variability &#40;SD&#44; LBGI and HBGI of CGSM data&#41; were evaluated every 6 months&#46; In the switch from MDI&#47;NPH to MDI&#47;G we reported less glycaemic variability according to the SD of CGSM&#44; which was not repeated after randomization when comparing MDI&#47;G vs&#46; CSII&#46; Given the limited value that this measurement has for the overall evaluation of glycaemic variability and the low number of patients we cannot provide a conclusive result&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Quality of life</span><p id="par0250" class="elsevierStylePara elsevierViewall">Quality of life is an important criterion in decision making&#44; but difficult to quantify&#46;</p><p id="par0255" class="elsevierStylePara elsevierViewall">In a recent revision&#44; Barnard et al&#46;<a class="elsevierStyleCrossRef" href="#bib0365"><span class="elsevierStyleSup">31</span></a> systematically evaluated 18 articles that met adequate inclusion criteria and concluded that the effects of CSII on quality of life remain unclear&#46;</p><p id="par0260" class="elsevierStylePara elsevierViewall">In our study&#44; during the first phase of treatment &#40;NPH to MDI&#47;G&#41; an improvement was noted in the DQOL&#44; at the expense of the subscale &#8220;satisfaction with treatment&#46;&#8221; After randomization&#44; as occurred with HbA1c&#44; the capacity of MDI&#47;G to improve QOL appeared to have reached its limit during the first 6 months and in the following months no changes were reported in the MDI&#47;G group&#46; However&#44; CSII therapy&#44; as with HbA1c&#44; goes further in improving QOL&#46; These results differ from another Spanish study by Lozano-Serrano et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0420"><span class="elsevierStyleSup">41</span></a> who found no differences between CSII and MDI using the same test as in our study &#40;the Spanish version of the Diabetes Quality of Life specific for diabetes related ESQOL&#41;&#44; though our results are nevertheless in agreement with other publications&#46; The systematic review of randomized studies published in 2012<a class="elsevierStyleCrossRef" href="#bib0400"><span class="elsevierStyleSup">37</span></a> concluded that CSII achieves a better QOL than MDI&#44; but with a low level of evidence&#46;</p><p id="par0265" class="elsevierStylePara elsevierViewall">The most robust study to date is by Hoogma et al&#46;<a class="elsevierStyleCrossRef" href="#bib0345"><span class="elsevierStyleSup">27</span></a>&#44; with 272 randomized patients in 5 countries treated either with MDI&#47;NPH or CSII and assessed via DQOL&#44; SF-12 and an additional questionnaire evaluating lifestyle&#44; manageability of the disease and acceptability of the types of treatment&#44; which were better for the group of patients using pumps&#46;</p><p id="par0270" class="elsevierStylePara elsevierViewall">In adults&#44; only 5 randomized studies have measured quality of life using different questionnaires for CSII vs&#46; MDI&#44;<a class="elsevierStyleCrossRefs" href="#bib0375"><span class="elsevierStyleSup">15&#44;17&#44;27</span></a> though only 2 with MDI&#47;G&#44;<a class="elsevierStyleCrossRefs" href="#bib0375"><span class="elsevierStyleSup">15&#44;17</span></a> and have obtained different results&#46; Bolli et al&#46;<a class="elsevierStyleCrossRef" href="#bib0375"><span class="elsevierStyleSup">15</span></a>&#44; using the diabetes treatment satisfaction questionnaire &#40;DTSQ&#41;&#44; found a better quality of life in the CSII group&#44; but Thomas et al&#46;<a class="elsevierStyleCrossRef" href="#bib0295"><span class="elsevierStyleSup">17</span></a>&#44; using the DQOL&#44; found no differences after 6 months of follow up&#46; Nicolucci et al&#46;<a class="elsevierStyleCrossRef" href="#bib0425"><span class="elsevierStyleSup">42</span></a>&#44; in a large &#40;1341 patients&#41;&#44; multicentre&#44; case&#8211;control study&#44; reported comparative data on QOL for MDI &#40;90&#37; glargine&#41; and CSII&#46; They used the DQOL&#44; DTSQ and the SF-36 Health Survey&#46; Their results suggest that gains in QOL in the CSII group came from greater flexibility&#44; less fear of hypoglycaemia and higher satisfaction with treatment&#46;</p></span></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Strengths and limitations</span><p id="par0275" class="elsevierStylePara elsevierViewall">The principal limitation of this study is the small sample size&#44; due mainly to the lack of finance for more CGMS and CSII&#44; which might then have revealed more differences&#46; Concerning the study design&#44; contacts between participants and healthcare providers were more frequent than in normal daily life&#46; This may diminish the external validity of the study&#44; but reinforces the conclusion that CSII could be better than MDI&#47;G even under strict conditions of patient follow-up&#46;</p><p id="par0280" class="elsevierStylePara elsevierViewall">The strengths of this study are the incorporation of CGMS to evaluate both treatments and the initial homogenization phase&#44; with a group of motivated and metabolically optimized patients in whom it was difficult to show improvements and who were not usual candidates for CSII&#46; The subsequent randomization enabled us to eliminate any personal bias in the differences found between the two alternative therapies&#46; And finally&#44; a prolonged follow-up of 6 months for each phase of the trial controlled the &#8220;dragging&#8221; phenomenon of some of the variables studied&#46;</p></span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Conclusions</span><p id="par0285" class="elsevierStylePara elsevierViewall">To the best of our knowledge&#44; this is the first randomized study in adult patients to find better HbA1c with CSII therapy vs&#46; MDI&#47;G in a maximally optimized adult group and with a prolonged follow-up of 6 months&#44; with no worsening in the other metabolic variables &#40;weight&#44; mild&#44; severe hypoglycaemia&#41; and QOL&#46;</p><p id="par0290" class="elsevierStylePara elsevierViewall">Further studies are needed to define the impact on glycaemic variability and QOL and to establish groups of patients who would benefit from this therapy&#44; as well as determine the most cost-effective indications for this therapeutic alternative&#46;</p></span><span id="sec0090" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Conflict of interests</span><p id="par0295" class="elsevierStylePara elsevierViewall">The authors declare no conflict of interest&#46;</p></span></span>"
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          "titulo" => "Resumen"
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            0 => array:2 [
              "identificador" => "abst0025"
              "titulo" => "Introducci&#243;n y objetivo"
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            1 => array:2 [
              "identificador" => "abst0030"
              "titulo" => "M&#233;todos"
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            2 => array:2 [
              "identificador" => "abst0035"
              "titulo" => "Resultados"
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            3 => array:2 [
              "identificador" => "abst0040"
              "titulo" => "Conclusiones"
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        3 => array:2 [
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          "titulo" => "Palabras clave"
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        4 => array:2 [
          "identificador" => "sec0005"
          "titulo" => "Introduction"
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          "identificador" => "sec0010"
          "titulo" => "Materials and methods"
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            0 => array:2 [
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              "titulo" => "Subjects"
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            1 => array:2 [
              "identificador" => "sec0020"
              "titulo" => "Design"
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            2 => array:2 [
              "identificador" => "sec0025"
              "titulo" => "Variables and instruments"
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              "identificador" => "sec0030"
              "titulo" => "Data analysis and statistics"
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          "titulo" => "Results"
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            0 => array:2 [
              "identificador" => "sec0040"
              "titulo" => "Baseline data &#40;Table 1&#41;"
            ]
            1 => array:2 [
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              "titulo" => "Phase 1&#58; homogenization &#40;Table 2&#41;"
            ]
            2 => array:2 [
              "identificador" => "sec0050"
              "titulo" => "Phase 2&#58; after randomization &#40;Table 2&#41;"
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          "titulo" => "Discussion"
          "secciones" => array:4 [
            0 => array:2 [
              "identificador" => "sec0060"
              "titulo" => "Metabolic control"
            ]
            1 => array:2 [
              "identificador" => "sec0065"
              "titulo" => "Hypoglycaemia"
            ]
            2 => array:2 [
              "identificador" => "sec0070"
              "titulo" => "Glycaemic variability"
            ]
            3 => array:2 [
              "identificador" => "sec0075"
              "titulo" => "Quality of life"
            ]
          ]
        ]
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          "identificador" => "sec0080"
          "titulo" => "Strengths and limitations"
        ]
        9 => array:2 [
          "identificador" => "sec0085"
          "titulo" => "Conclusions"
        ]
        10 => array:2 [
          "identificador" => "sec0090"
          "titulo" => "Conflict of interests"
        ]
        11 => array:2 [
          "identificador" => "xack228641"
          "titulo" => "Acknowledgements"
        ]
        12 => array:1 [
          "titulo" => "References"
        ]
      ]
    ]
    "pdfFichero" => "main.pdf"
    "tienePdf" => true
    "fechaRecibido" => "2015-05-26"
    "fechaAceptado" => "2015-09-03"
    "PalabrasClave" => array:2 [
      "en" => array:1 [
        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Keywords"
          "identificador" => "xpalclavsec684049"
          "palabras" => array:3 [
            0 => "CSII"
            1 => "MDI"
            2 => "Type 1 diabetes"
          ]
        ]
      ]
      "es" => array:1 [
        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Palabras clave"
          "identificador" => "xpalclavsec684050"
          "palabras" => array:3 [
            0 => "ISCI"
            1 => "MDI"
            2 => "Diabetes tipo 1"
          ]
        ]
      ]
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    "tieneResumen" => true
    "resumen" => array:2 [
      "en" => array:3 [
        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Background and objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Advantages of continuous subcutaneous insulin infusion &#40;CSII&#41; over multiple daily injections with glargine &#40;MDI&#47;G&#41; are still uncertain&#46; We compared CSII vs&#46; MDI&#47;G therapy in unselected patients with type 1 diabetes using continuous glucose monitoring &#40;CGSM&#41;&#46; The primary end-points were glycaemic control and quality of life &#40;QOL&#41;&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A total of 45 patients with long-term diabetes and mean HbA1c values of 8&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;8&#37; &#40;70&#46;5<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>15&#46;4<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#41;&#44; previously treated with MDI&#47;NPH&#44; were switched to MDI&#47;G for 6 months and then&#44; unfulfilling therapy CSII indication&#44; were randomly assigned to CSII or MDI&#47;G for another six months&#46; We evaluated QOL &#40;EsDqol&#41; and glycaemic control by measuring HbA1c levels&#44; rate of hypoglycaemia&#44; ketoacidosis and CGSM data&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">After the first phase &#40;MDI&#47;NPH to MDI&#47;G&#41; there was a significant improvement in total EsDQOL &#40;99&#46;72<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18&#46;38 vs&#46; 92&#46;07<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>17&#46;65&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;028&#41;&#44; a 0&#46;5&#37; decrease in HbA1c values &#40;8&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;2 vs&#46; 7&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;7&#37; &#91;68<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#46;7 vs&#46; 63<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;5<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#93;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;032&#41;&#44; an improvement in glycaemic variability &#40;standard deviation 66&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>14 vs&#46; 59&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>16<span class="elsevierStyleHsp" style=""></span>mg&#47;dl&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05&#41;&#44; a decrease in insulin requirements &#40;0&#46;87<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;29 vs&#46; 0&#46;80<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;25<span class="elsevierStyleHsp" style=""></span>U&#47;kg&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;049&#41;&#44; a decrease in number of severe hypoglycaemia episodes &#40;0&#46;44<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;9 vs&#46; 0&#46;05<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;2&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;014&#41;&#44; and an increase in periods of normoglycaemia measured with CGSM &#40;15&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>10&#46;9&#37; vs&#46; 23<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18&#46;4&#37;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;003&#41;&#46; Six months after randomization&#44; significant improvements were seen in the HbA1c &#40;7&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;7 vs&#46; 7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;6&#37; &#91;63<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;5 vs&#46; 53<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;5<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#93;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41; and EsQOL &#40;91&#46;66<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>22 vs&#46; 84&#46;53<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;63&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;045&#41; only in the CSII group&#46; The HbA1c value was significantly lower when compared with the MDI&#47;G group &#40;CSII 7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;6&#37; &#91;53<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;5<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#93; vs&#46; MDI&#47;G 7&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;9&#37; &#91;59&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#46;7<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#93;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;03&#41;&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Intensive insulin therapy with CSII vs&#46; MDI&#47;G was associated with better levels of HbA1c in patients with long-term type 1 diabetes&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Background and objective"
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            "titulo" => "Methods"
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            "titulo" => "Results"
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            "titulo" => "Conclusions"
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      "es" => array:3 [
        "titulo" => "Resumen"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducci&#243;n y objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Las ventajas de la infusi&#243;n subcut&#225;nea continua de insulina &#40;ISCI&#41; sobre m&#250;ltiples inyecciones diarias de insulina con glargina &#40;MDI&#47;G&#41; son todav&#237;a inciertas&#46; Comparamos ISCI frente a MDI&#47;G en pacientes con diabetes tipo 1 sin indicaci&#243;n de terapia ISCI utilizando la monitorizaci&#243;n continua de glucosa &#40;CGSM&#41;&#46; Los objetivos primarios fueron el control gluc&#233;mico y la calidad de vida &#40;QOL&#41;&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Un total de 45 pacientes con diabetes 1 de largo tiempo de evoluci&#243;n y valores medios de HbA1c de 8&#44;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#44;8&#37; &#40;70&#44;5<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>15&#44;4<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#41;&#44; previamente tratados con MDI&#47;NPH&#44; fueron cambiados a MDI&#47;G durante 6 meses y luego sin cumplir criterios cl&#237;nicos para terapia ISCI asignados aleatoriamente a ISCI o MDI&#47;G durante seis meses&#46; Se evalu&#243; la calidad de vida &#40;EsDqol&#41; y el control de la glucemia mediante la medici&#243;n de los niveles de HbA1c&#44; la tasa de hipoglucemias&#44; cetoacidosis y datos de CGSM&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Despu&#233;s de la primera fase &#40;MDI&#47;NPH a MDI&#47;G&#41; hubo una mejora significativa en EsDQOL total &#40;99&#44;72<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18&#44;38 vs&#46; 92&#44;07<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>17&#44;65&#59; p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;028&#41;&#44; una disminuci&#243;n de 0&#44;5&#37; en los valores de HbA1c &#40;8&#44;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#44;2 vs&#46; 7&#44;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#44;7&#37; &#91;68<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#44;7 vs&#46; 63<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#44;5<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#93;&#59; p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;032&#41;&#44; una mejora en la variabilidad de la glucemia &#40;desviaci&#243;n est&#225;ndar 66&#44;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>14 vs&#46; 59&#44;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>16<span class="elsevierStyleHsp" style=""></span>mg&#47;dl&#59; p &#60;0&#44;05&#41;&#44; una disminuci&#243;n en las necesidades de insulina &#40;0&#44;87<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#44;29 vs&#46; 0&#44;80<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#44;25<span class="elsevierStyleHsp" style=""></span>U&#47;kg&#59; p &#60;0&#44;049&#41;&#44; una disminuci&#243;n en el n&#250;mero de episodios de hipoglucemia grave &#40;0&#44;44<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#44;9 vs&#46; 0&#44;05<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#44;2&#59; p &#60;0&#44;014&#41;&#44; y un aumento en los periodos de normoglucemia medidos con CGSM &#40;15&#44;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>10&#44;9&#37; vs&#46; 23<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18&#44;4&#37;&#59; p &#60;0&#44;003&#41;&#46; Seis meses despu&#233;s de la aleatorizaci&#243;n&#44; se observaron mejoras significativas en la HbA1c &#40;7&#44;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#44;7 vs&#46; 7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#44;6&#37;&#59; &#91;63<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#44;5 vs&#46; 53<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;5<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#93;&#59; p &#60;0&#44;001&#41; y la calidad de vida &#40;91&#44;66<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>22 vs&#46; 84&#44;53<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#44;63&#59; p &#60;0&#44;045&#41; s&#243;lo en el grupo ISCI&#46; El valour de HbA1c fue significativamente menor en ISCI en comparaci&#243;n con el grupo MDI&#47;G &#40;CSII 7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#44;6&#37; &#91;53<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#44;5<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#93; vs&#46; MDI&#47;G 7&#44;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#44;9&#37; &#91;59&#44;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#44;7<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#93;&#59; p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;03&#41;&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">La terapia insul&#237;nica intensiva con ISCI vs&#46; MDI&#47;G se asoci&#243; con mejores niveles de HbA1c en pacientes con diabetes tipo 1 de larga evoluci&#243;n&#46;</p></span>"
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          "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">HbA1c at baseline&#44; and after 6 and 12 months with MDI and CSII&#46; &#42;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05 basal&#8211;6 month in 2 groups&#59; &#42;&#42;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05 6 month&#8211;12 month in CSII group&#59; &#36;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05 MDI&#47;G vs&#46; CSII 12 month&#46;</p>"
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                  \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="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Total<br><span class="elsevierStyleItalic">N</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>38&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">MDI&#47;G<br><span class="elsevierStyleItalic">N</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>23&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">CSII<br><span class="elsevierStyleItalic">N</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>15&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black"><span class="elsevierStyleItalic">p</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Age &#40;years&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">29&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">28<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">31<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>10&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Gender &#40;men&#47;women&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">21&#47;24&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">15&#47;15&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">6&#47;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Years with diabetes&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">13<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">12&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">16<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Body mass index &#40;kg&#47;m<span class="elsevierStyleSup">2</span>&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">25<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">24&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">26<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Daily insulin dose&#47;kg&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">0&#46;87<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">0&#46;87<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">0&#46;87<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Mild hypoglycaemia&#47;week&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">3&#46;04<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">3&#46;03<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">3&#46;07<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Severe hypoglycaemia&#47;6 months&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">0&#46;44<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">0&#46;43<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">0&#46;46<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">SMBG&#47;day&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">3&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">HbA1c &#37; &#40;mmol&#47;mol&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">8&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;2 &#40;68<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">8&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;2 &#40;67&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">8&#46;5<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;2 &#40;69&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Ketoacidosis &#40;previous 6 months&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Hospitalization &#40;previous year&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">4 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Preproliferative retinopathy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">5 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Proliferative retinopathy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">7 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Incipient nephropathy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">3 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Established nephropathy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Unawareness hypoglycaemia&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Hypertension&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">8 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">ns&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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                  <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="" valign="top" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " colspan="3" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Homogenization phase</th><th class="td" title="table-head  " colspan="3" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Randomized study</th></tr><tr title="table-row"><th class="td" title="table-head  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Basal<br>MDI&#47;NPH&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">6 months<br>MDI&#47;glargine&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black"><span class="elsevierStyleItalic">p</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">12 months<br>MDI&#47;glargine&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">12 months<br>CSII&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black"><span class="elsevierStyleItalic">p</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">N</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">38&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">38&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">23&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">15&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Body mass index&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">25&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">25&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;014&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">25&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">26&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;42&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Basal insulin dose &#40;IU&#47;day&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">41&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>16&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">36&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>15&#46;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;001&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">34&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>12&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">34&#46;34<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18&#46;66&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Total insulin dose &#40;IU&#47;kg&#47;day&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;87<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;29&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;80<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;25&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;049&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;77<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;24&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;78<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;21&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">HbA1c &#37; &#40;mmol&#47;mol&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">8&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;2 &#40;68<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;7 &#40;63<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;032&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;9 &#40;59&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;6 &#40;53<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;5&#41;<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;03&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">HbA1c &#60;7&#46;5&#37; &#40;58&#46;5<span class="elsevierStyleHsp" style=""></span>mmol&#47;mol&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">33&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">36&#46;8&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">52&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">67&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;46&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">SMBG&#47;day&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">4&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">3&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">4&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;008&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Severe hypoglycaemia&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;44<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;050<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;014&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;05<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;29<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;08&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="7" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="7" align="left" valign="top"><span class="elsevierStyleBold">CGMS</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Mean glycaemia&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">172&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>42&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">162<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>30&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;104&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">146&#46;78<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>36<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">&#35;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">145<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>20&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Standard deviation&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">66&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>14&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">59&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>16&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;05&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">58<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>13&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">65<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>24&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">&#37; normoglycaemia&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">15&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>10&#46;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">23<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;03&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">50&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">&#35;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">50<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>13&#46;6<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;84&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">&#37; hypoglycaemia&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">8&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#46;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;56&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">9&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">&#37; hyperglycaemia&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">73&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>21&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">69&#46;38<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>21&#46;47&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;30&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">43<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>16&#46;2<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">&#35;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">42<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>12<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;88&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">LBGI&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">2&#46;1&#177; 2&#46;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">1&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;42&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">2&#46;74<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span> 2&#46;24&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">2&#46;89<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>2&#46;56&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">HBGI&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">9&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">8&#46;1<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;32&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">6&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">5&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span> 3<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;06&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleBold">DQOL</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">99&#46;72<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>18&#46;38&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">92&#46;07<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>17&#46;65&nbsp;\t\t\t\t\t\t\n
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        "texto" => "<p id="par0300" class="elsevierStylePara elsevierViewall">This study was undertaken with finance from the <span class="elsevierStyleGrantSponsor" id="gs1">Fondo de Investigaci&#243;n Sanitaria</span> &#40;ISCIII&#41; &#40;PI07&#47;90330&#41;&#44; <span class="elsevierStyleGrantSponsor" id="gs2">Junta de Andaluc&#237;a</span> &#40;0240&#47;2006&#41;&#46;</p> <p id="par0305" class="elsevierStylePara elsevierViewall">We acknowledge other collaborations&#58;<elsevierMultimedia ident="tbl0005"></elsevierMultimedia></p> <p id="par0310" class="elsevierStylePara elsevierViewall">MSRA designed the study and analysis&#44; conducted data collection&#44; data interpretation and writing of the manuscript&#46; MDL conducted data collection&#44; data interpretation and writing of the manuscript&#46; IGM conducted data collection&#44; data interpretation and writing of the manuscript&#46; AM designed the study and analysis and conducted data collection&#46; VM conducted data collection and data interpretation&#46; IC conducted data collection&#46; MH conducted data collection and data interpretation&#46; SG conducted data collection and data interpretation&#46; SM designed the study and analysis&#46; MC conducted data collection and data interpretation&#46; MTA was involved in the design of the psychological assessment protocol of this study&#44; and the coordination the data collection process&#44; and in the interpretation of the data and in reviewing&#46; GR and FS designed the study and analysis and helped write the manuscript&#46;</p>"
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