The Psychosocial Outcomes of Advanced Hybrid Closed-Loop System in Children and Adolescents with Type 1 Diabetes
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Abstract Objective: The study was carried out to determine the psychosocial outcomes of Advanced Hybrid Closed-Loop (AHCL) systems in children and adolescents with Type 1 Diabetes (T1D). Research design&Method: The study population consisted of 60 children and adolescents with T1D.Standard clinical procedures, including both glycemic indicators, e.g., sensor-measured time within the 70–180 mg/dL range and glycated hemoglobin (HbA1c) levels, and psychosocial metrics were used for data collection. The psychosocial metrics included the Pediatric Quality of Life Inventory (PedsQL) 3.0 Diabetes Module for both children (8-12 years) and parents; the Quality of Life for Youth scale for adolescents (13-18 years); the Strengths and Difficulties Questionnaire (SDQ); the Hypoglycemia Fear Survey for Children(HFS-C); the Revised Child Anxiety and Depression Scale (R-CADS); and AHCLS-specific DTSEQ satisfaction and expectation survey. These metrics were evaluated at the baseline and after six months of AHCL use. Results: Of the 60 children and adolescents with T1D for whom the AHCL system was utilized, 41 patients, 23 female and 18 male, completed the surveys. The mean age of the 41 children and adolescents that constituted the study sample was 12.5 ± 3.2 (min. 6.7, max. 18) years. The time spent within the target glycemic range, i.e., time-in-range (TIR), improved from 76.9 ± 9% at the baseline to 80.4 ± 5% after six months of AHCL system use(p=0.034). Additionally, HbA1c levels reduced from 7.1% ± 0.7% at the baseline to 6.8% ± 0.8% after six months of AHCL system use(P=0.031). The most notable decline in HbA1c was observed in participants with higher baseline HbA1c levels. All patients’ HFS-C and AHCL system-specific DTSEQ satisfaction and expectation survey scores were within the normal range at the baseline and remained unchanged during the follow-up period. No significant difference was found in the R-CADS scores of children and adolescents between baseline and after six months of AHCL system use. However, there was a significant decrease in the R-CADS scores of children and adolescents administered by their parents. Patients’ PedsQL scores were high both at the baseline and after six months of AHCL system use. The evaluation of children and adolescents with SDQ revealed high overall difficulty scores at the baseline. On the other hand, no significant improvement was achieved in SDQ scores after six months of AHCL system use compared to baseline. Conclusions: This is the first study to investigate in detail the psychosocial outcomes of AHCL system use in T1D patients and their parents. Although state-of-the-art technologies such as AHCL provide patients with more flexibility in their daily lives and information about glucose fluctuations, the AHCL resulted in a TIR above the recommended target range without a change in QOL, HFS-C, SDQ, and R-CADS scores. The scores obtained from the R-CADS conducted by the parents of their children indicated that the use of pumps caused a psychological improvement in the long term, with a significant decrease in the R-CADS scores of the children and adolescents with T1D. Further studies are needed to elucidate the reasons for AHCL discontinuation and determine intervention strategies.
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The Psychosocial Outcomes of Advanced Hybrid Closed-Loop System in Children and Adolescents with Type 1 Diabetes | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article The Psychosocial Outcomes of Advanced Hybrid Closed-Loop System in Children and Adolescents with Type 1 Diabetes Arzu Jalilova, Birsen Şentürk Pilan, Günay Demir, Burcu Özbaran, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3933235/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 24 Apr, 2024 Read the published version in European Journal of Pediatrics → Version 1 posted 7 You are reading this latest preprint version Abstract Objective : The study was carried out to determine the psychosocial outcomes of Advanced Hybrid Closed-Loop (AHCL) systems in children and adolescents with Type 1 Diabetes (T1D). Research design&Method : The study population consisted of 60 children and adolescents with T1D.Standard clinical procedures, including both glycemic indicators, e.g., sensor-measured time within the 70–180 mg/dL range and glycated hemoglobin (HbA1c) levels, and psychosocial metrics were used for data collection. The psychosocial metrics included the Pediatric Quality of Life Inventory (PedsQL) 3.0 Diabetes Module for both children (8-12 years) and parents; the Quality of Life for Youth scale for adolescents (13-18 years); the Strengths and Difficulties Questionnaire (SDQ); the Hypoglycemia Fear Survey for Children(HFS-C); the Revised Child Anxiety and Depression Scale (R-CADS); and AHCLS-specific DTSEQ satisfaction and expectation survey. These metrics were evaluated at the baseline and after six months of AHCL use. Results : Of the 60 children and adolescents with T1D for whom the AHCL system was utilized, 41 patients, 23 female and 18 male, completed the surveys. The mean age of the 41 children and adolescents that constituted the study sample was 12.5 ± 3.2 (min. 6.7, max. 18) years. The time spent within the target glycemic range, i.e., time-in-range (TIR), improved from 76.9 ± 9% at the baseline to 80.4 ± 5% after six months of AHCL system use(p=0.034). Additionally, HbA1c levels reduced from 7.1% ± 0.7% at the baseline to 6.8% ± 0.8% after six months of AHCL system use(P=0.031). The most notable decline in HbA1c was observed in participants with higher baseline HbA1c levels. All patients’ HFS-C and AHCL system-specific DTSEQ satisfaction and expectation survey scores were within the normal range at the baseline and remained unchanged during the follow-up period. No significant difference was found in the R-CADS scores of children and adolescents between baseline and after six months of AHCL system use. However, there was a significant decrease in the R-CADS scores of children and adolescents administered by their parents. Patients’ PedsQL scores were high both at the baseline and after six months of AHCL system use. The evaluation of children and adolescents with SDQ revealed high overall difficulty scores at the baseline. On the other hand, no significant improvement was achieved in SDQ scores after six months of AHCL system use compared to baseline. Conclusions: This is the first study to investigate in detail the psychosocial outcomes of AHCL system use in T1D patients and their parents. Although state-of-the-art technologies such as AHCL provide patients with more flexibility in their daily lives and information about glucose fluctuations, the AHCL resulted in a TIR above the recommended target range without a change in QOL, HFS-C, SDQ, and R-CADS scores. The scores obtained from the R-CADS conducted by the parents of their children indicated that the use of pumps caused a psychological improvement in the long term, with a significant decrease in the R-CADS scores of the children and adolescents with T1D. Further studies are needed to elucidate the reasons for AHCL discontinuation and determine intervention strategies. Advanced Hybrid Closed-Loop Type 1 Diabetes Psychosocial Outcomes Pediatric Endocrinology Glycemic Control Introduction Type 1 diabetes (T1D) is one of childhood and adolescence's most common chronic endocrine disorders, significantly impacting their physical and emotional development ( 1 – 3 ). T1D patients must make significant lifestyle adjustments to meet their daily exogenous insulin needs, including checking blood glucose levels regularly and managing dietary consumption. Difficulties in managing glycemic control negatively affect psychological health, leading to poor glycemic control and quality of life (QoL) ( 4 , 5 ). The studies indicated that automated insulin delivery (AID) systems improve glycemic control in individuals with T1D. These benefits are universally observed across different age and gender groups and are not influenced by the duration of T1D, previously used insulin delivery methods, or initial glycated hemoglobin (HbA1c) levels ( 6 – 9 ). The AID systems currently available on the market require users to manually enter the insulin doses at mealtime and indicate physical activity. Meanwhile, the system autonomously adjusts insulin delivery ( 10 ). Compared to a number of studies on the glycemic outcomes of AID systems in this patient group, there are only a handful of studies on their psychosocial impact. Specifically, there are even fewer studies on the impact of AID systems on the QoL and emotional well-being of both children and their parents, including the quality and duration of sleep. Although the patient-reported outcomes on the impact of AID systems on QoL vary, the overarching consensus is that AID systems often improve QoL ( 11 – 13 ). Additionally, some studies have reported a significant reduction in the fear of hypoglycemia ( 11 , 13 ), while others have reported a decrease in diabetes-related stress and an improvement in sleep quality with the use of AID systems ( 14 , 15 ). It's important to note that Advanced Hybrid Closed-Loop (AHCL) systems do not fully automate every aspect of diabetes management. Therefore, human and psychosocial factors continue to play a significant role in effectively utilizing these systems. In this context, the objective of this study is to describe the experience of children with T1D on Minimed 780G systems in terms of diabetes difficulties, depression, anxiety, fear of hypoglycemia, and QoL. Material and Methods The population of this prospective interventional study consisted of children and adolescents aged 6–18 years who used MiniMed™ 780 G (Medtronic, Northridge, CA, USA) and their parents or caregivers. The study protocol was approved by the Ege University Ethics Committee (Approval No. 21-3.1T/23. Participants and their parents or caregivers were briefed on the objectives and methodology of the study. Informed consent was obtained from each patient included in the study. Study Protocol Participants were first given a tutorial in order to familiarize themselves with the manual mode of the system and its various functionalities. Auto-Mode was activated three and ten days after the tutorial in those using the Minimed 640G and MDI, respectively. Pediatric psychiatrists assessed all T1D patients using the Schedule for Affective Disorders and Schizophrenia for School-Age Children/Present and Lifetime Turkish Version (K-SADS-PL-T) ( 16 ) based on the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria ( 17 , 18 ) to rule out psychiatric conditions. All subjects, along with their parents or caregivers, were asked to fill out several validated questionnaires including the Pediatric Quality of Life Inventory (PedsQL) 3.0diabetes module ( 19 – 21 ), Strengths and Difficulties Questionnaire (SDQ) ( 22 , 23 ), Hypoglycemia Fear Survey for Children ( 24 , 25 ), The Revised Child Anxiety and Depression Scale (R-CADS) ( 26 , 27 ), and the AHCL system-specific DTSEQ satisfaction and expectation survey. These assessments were completed before the use of the AID system at the baseline and then again after six months of AHCL system use. The SDQ focuses on both positive attributes and challenges in children, consisting of items that evaluate prosocial behavior and various difficulties ( 23 ). SDQ is divided into five categories: "Conduct Problems," "Hyperactivity and Inattention," "Emotional Symptoms," "Peer Problems," and "Prosocial Behaviors." The aggregation of scores in different subsections enables the calculation of "internalizing" and "externalizing" problem indices ( 22 ). Scoring tiers for the SDQ are categorized as normal ( 16) psychosocial functioning. The R-CADS is used for the self-assessment of anxiety and depression symptoms in children and adolescents. R-CADS consists of 47 items in six subscales, addressing various forms of anxiety and depression disorders, such as separation anxiety and social phobia. R-CADS-P, the version of R-CADS for use by parents, evaluates anxiety and depression symptoms in children and adolescents based on parental observations ( 28 ). The Hypoglycemia Fear Survey for Children (HFS-C) comprises 24 items in behavior and worriedness subscales and additional items related to special situations related to hypoglycemia. Items are scored on a scale from 0 (never) to 4 (almost always). The total score obtained from HFS-C ranges from 24 to 120 ( 24 ). The PedsQL 3.0 diabetes module aims to assess Health-Related QoL (HRQOL) specific to diabetes. PedsQL comes in two versions based on age groups, comprising five subscales that cover various dimensions of diabetes care, including diabetes symptoms, treatment barriers, and treatment adherence ( 19 – 21 ). The DTSEQ satisfaction and expectation survey was specifically formulated for use with the "Minimed 780 G" system, utilizing the "Davis Technique" for content validity assurance. The total score that can be obtained from the AHCL system-specific DTSEQ satisfaction and expectation survey ranges from 21 to 105. Statistical Analysis SPSS 22.0 (Statistical Product and Service Solutions for Windows, Version 22.0, IBM Corp., Armonk, NY, U.S., 2013) software package was used to conduct the statistical analyses of the collected data. The normal distribution characteristics of the variables on all metrics related to system usage, glycemic control, and psychosocial factors were analyzed using the Kolmogorov-Smirnov test. Additionally, the Shapiro-Wilk test was used to confirm the normal distribution assumptions of quantitative data within each subset of participants. Significance in statistical variation was ascertained through multiple tests. Accordingly, the student’s t-test and the Mann-Whitney U test were used for normally and non-normally distributed numerical data, respectively. On the other hand, cross-tabulation, Pearson's chi-square test, and Fisher's exact test were used to compare the categorical data. Probability ( p ) statistics of ≤ 0.05 were deemed to indicate statistical significance. Pearson’s correlation coefficient was used to assess the correlations between normally distributed data, whereas Spearman's rank correlation coefficient was used to assess the correlations between nonparametric data. Results Of the 60 children and adolescents with T1D, for whom the AHCL system was utilized, one patient was excluded from the study due to a psychiatric diagnosis at the beginning, and 13 were lost to follow-up.46 (67%) patients completed the 6th-month follow-up. However, four of these patients refused to fill out the sixth-month survey. In the end, 41 patients, 23 female and 18 male, were included in the study sample. The mean age of the study sample was 12.5 ± 3.2 (min. 6.7, max. 18) years. The mean duration of T1D in these patients was 5.5 ± 5.0 years. None of the children was on psychotropic medication during the study period. Of the 41 patients, 21 were on the Minimed 640G system, 19 on multiple daily insulin therapy (MDI), and 1 on the MiniMed Paradigm Veo pump (Table 1 ). Time-in-range (TIR) (70–180 mg/dL) increased from 76.9 ± 9% at the baseline to 80.4 ± 5% after six months of AHCL system use (p = 0.03). Mean HbA1c decreased from 7.1% ± 0.7% at the baseline to 6.8% ±0.8% after six months of AHCL system use (p = 0.03). SDQ Scores The mean total SDQ score was 24 at baseline and 22 after six months of AHCL system use (Table 2 ). There was no significant difference between baseline and sixth-month total SDQ and SDQ subscale scores. Table 1 Demographic information of the participants Age (y) 12.5 years ± 3.2 Gender (Male/Female) 18/23 Diabetes duration (y) 5.5 ± 5.0 Basal HbA1c 7.1% ± 0.7% Basal Therapy Minimed VEO pump Minimed 640 pump MDI 1 21 19 Table 2 Comparison of SDQ outcomes between baseline and 6th month SDQ (children and parents) Baseline 6th month Children Median Minimum Maximum Median Minimum Maximum p Emotional symptoms 2 0 8 1 0 8 0.50 Hyperactivity/inattention 6 2 9 5 2 9 0.06 Conduct problems 2 0 8 2 0 7 0.30 Peer relationship problems 5 3 6 4 2 10 0.30 Prosocial behavior 9 5 10 8 5 10 0.60 Total difficulty score 24 13 30 22 13 40 0.25 Parents Emotional symptoms 1 0 8 2 0 7 0.45 Hyperactivity/inattention 5 0 13 4 0 9 0.10 Conduct problems 2 0 8 2 0 4 0.08 Peer relationship problems 5 0 12 5 0 8 0.40 Prosocial behavior 9 2 12 9 2 10 0.10 Total difficulty score 21 4 52 22 4 30 0.25 R-CADS and R-CADS-PScores There was no significant difference between baseline and sixth-month R-CADS scores. On the other hand, R-CADS-P scores revealed that the total depression and anxiety scores of the children and adolescents decreased at the sixth month compared to baseline (Table 3 ). Table 3 Comparison of R-CADS (children and parents) outcomes between baseline and 6th month R-CADS (children and parents) Baseline 6th month Children Median Min Max Median Min Max p Total anxiety score 39 27 76 39 27 80 0.50 Major depression scale 40 26 74 40 27 80 0.30 Parents Total anxiety score 47 35 80 44 34 80 0.04 Major depression scale 47 34 80 45 34 80 0.03 PedsQL 3.0 Diabetes Module Scores There was no significant difference between baseline and sixth-month data in PedsQL3.0 Diabetes Module scores (p = 0.26) (Tables 4 and 5 ) Table 4 Pediatric Quality of Life Inventory (PedsQL) 3.0 Diabetes Module outcomes between baseline and 6th month PedsQL (child and parents) Baseline 6th month Children Median Min Max Median Min Max p Diabetes symptoms 35 22 44 32 17 41 0.65 Treatment barriers 10 1 16 9.5 1 16 0.40 Treatment adherence 24 8 28 19 5 24 0.30 Worry 11 0 12 9 0 12 0.20 Communication 11 0 12 1 0 11 0.10 Total score 89 44 112 83 37 108 0.25 Parents Diabetes symptoms 35.5 16 43 35.5 13 42 0.95 Treatment barriers 12 3 16 11.5 2 16 0.60 Treatment adherence 21.5 12 28 20 4 28 0.40 Worry 10.5 2 12 10 4 12 0.40 Communication 1 0 11 9.5 5 12 0.50 Total score 87 48 108 85 37 108 0.80 Table 5 Diabetes-related quality of life for youth short form outcomes between baseline and 6th month DQOLY-SF (adolescent) Baseline 6th month Children Median Min Max Median Min Max p Impact of symptom ( ≤ 3) 2 0 5 3 0 6 0.20 Impact of treatment ( ≤ 3) 1 0 11 2 0 9 0.45 Impact on activities ( ≤ 5) 1 0 16 1 0 12 0.15 Parents' issues ( ≤ 3) 5 0 11 6 0 9 0.20 Worries ( ≤ 7) 4 0 23 3 0 12 0.60 Health Perception 1 0 2 1 0 2 0.40 Total score 16 0 68 17 4 43 0.70 HFS-C Scores The median total HFS-C score decreased from 40 (min. 24, max. 102) at the baseline to 38 (min. 16, max. 90) at the sixth month (p = 0.56) (Table 6 ). Table 6 Hypoglycemia Fear Scale for Children outcomes between baseline and 6th month HFS (child) Baseline 6th month Children Median Min Max Median Min Max p Specific situations 11 7 29 10 6 26 0.10 General Fears 18 9 44 18 4 40 0.60 Behavior 10 8 29 10 6 35 0.95 Total score 40 24 102 38 16 90 0.55 AHCL System-Specific DTSEQ Satisfaction and Expectation Survey Scores The AHCL system-specific DTSEQ satisfaction and expectation survey scores were within the typical range at the baseline. There was an increase, albeit insignificant, in the total score in the sixth month (baseline mean total score: 75 ± 13 vs. sixth month mean total score: 79 ± 12; p = 0.16). Discussion A number of studies revealed that the use of MiniMed™ 780 G (Medtronic, Northridge, CA USA) in children with T1D aged 8 to 18 significantly increased TIR towards the target range of 70–180 mg/dL ( 29 – 31 ). However, this is the first study to date addressing the long-term psychological impact of the MiniMed™ 780 G in detail. Consequently, it was determined that the anxiety and depression levels of children and adolescents included in the study significantly decreased with the use of AHCL systems, according to their parents and caregivers. The studies on the psychosocial problems of children with T1D based on SDQ subscale scores revealed emotional and behavioral problems as their primary problems ( 32 – 34 ).In contrast, a study conducted with Danish children and adolescents reported lower or comparable levels of emotional difficulties with the use of AHCL systems compared to the control group, whereas parents and caregivers of these children and adolescents reported even less favorable outcomes ( 34 ). In a controlled study by Boogerd et al. based on SDQ scores, both children with T1D and their parents reported significantly more prosocial problems compared to the control group ( 35 ).In contrast, a study reported significant improvements in satisfaction with the use of HCL Minimed™ 670G ( 36 ). The improvement in outcomes with the use of HCL Minimed™ 670G can be due to reduced worriedness, increased confidence, and trust in the system with improved glycemic control. In comparison, in this study, the baseline SDQ scores revealed high total difficulty scores, whereas the SDQ subscale scores indicated symptoms of hyperactivity/inattention and peer relationship problems. These results did not improve after six months of AHCL system use. A recent review by Silina et al. showed that adolescents with T1D and their parents were more predisposed to anxiety and depression symptoms than healthy somatic children and their parents ( 37 ).In a four-week study conducted with 13 young children aged 7 to 10, the insulin pump therapy was changed to an AID system. Consequently, it was determined that the AID system significantly reduced the depression levels of young children as well as their parents. In addition, in the said study, it was observed that children's depression scores (CDI-2) with Tandem Control IQ did not decrease significantly compared to sensor-augmented pump therapy (SAP)at the end of 4 weeks ( 11 ). In comparison, in this study, the total R-CADS and R-CADS subscale scores of the children and adolescents with T1D were within the normal range both at the baseline and after six months of AHCL system use, and there were no significant differences between the baseline and sixth-month total R-CADSand R-CADSsubscale scores related to anxiety and depression. On the contrary, the sixth-month R-CADS-P scores were significantly better compared to the baseline R-CADS-P, indicating better depression and anxiety outcomes. The absence of diabetes-related depression and anxiety symptoms in children and adolescents with T1D included in this study at the baseline may be attributed to good metabolic control. In terms of QoL, the mean total PedsQL scores of the children and adolescents with T1D included in this study were high at the baseline and did not change after six months of AHCL system use. Similarly, Wheeler et al. did not report any significant difference in QoL scores of T1D patients with a mean age of 23 years between the use of Minimed™ 780G, SAP, and predictive low glucose suspend pump(PLGS) therapy ( 12 ).In contrast, Beato-Vibora PI. reported a significant improvement in QoL scores after three months of Minimed™ 670Guse ( 38 ). Bisio et al.( 11 ) also reported significant improvements in every measure of QoL in children with T1D with the use of AID compared to SAP. However, in the same study, the parents of these children did not report significant improvements in QoL or the emotional well-being of their children with the use of AID. In comparison, in this study, the QoL of the patients with T1D was high at the baseline, possibly due to good metabolic control. As demonstrated in previous studies, good glycemic control leads to a good QoL ( 39 , 40 ). The cultural and social factors related to family support and the fact that 53% of the patients were using a pump before they were on a flexible nutrition model might also have contributed to our patients coping with diabetes-related problems. The total AHCL system-specific expectation and satisfaction survey scores have improved, albeit not significantly, between the baseline and after six months of AHCL system use. This improvement might be due to decreased worriedness, increased confidence and trust in the system, improved glycemic control, and enhanced diabetes management. This is an important finding, given that although users find AID systems helpful in terms of daily use, they report difficulties in connecting the system. Wheeler et al. found no significant difference between AID and SAP + PLGM in terms of treatment satisfaction based on the responses of diabetic adolescents and their parents ( 12 ). In another study evaluating the hopes and expectations of family members on AID systems, it was reported that there is an expectation that this diabetes technology will alleviate diabetes-specific anxiety and burden in individuals with diabetes and other family members and that this system can reduce daily stress and, most importantly, improve family relationships ( 41 ). In this study, no significant difference was found between baseline and sixth-month HFS-C scores. Fear of hypoglycemia, particularly night fear, is common among diabetic patients and their families. Bisio et al. reported that Tandem Control IQ reduced hypoglycemia fear in caregivers compared to SAP therapy over one month ( 11 ). Although no significant difference was found in the follow-up, the decrease in the total score may reflect the decrease in fear and anxiety of hypoglycemia. Technology alarms can also cause increased levels of extra anxiety, becoming annoying, especially at night. As a matter of fact, Barnard et al. reported that alarms were a problem for some(n = 13)participants, noting that they were more irritating, especially when they were causing recurring sleepless nights and other family members to wake up ( 42 ). Although AID systems improved glycemic control in our study, the decrease observed in the anxiety and depression levels of children and adolescents with T1D under real-life conditions in the long term was only from the perspective of parents and caregivers. Our study has some limitations. Our study was conducted with a relatively small number of patients and there was no control group. In conclusion, AHCL insulin delivery represents the latest technology in the treatment of T1D. However, this study’s findings revealed the need for further research to determine the AID systems' long-term psychological and physical benefits. Concluding Remarks To the best of our knowledge, this is the first study to date to investigate in detail the psychological impact of AHCL systems on T1D patients and their parents. Even though such technologies, i.e., Minimed™ 780G systems, give flexibility to diabetic patients in their daily living activities, they did not improve their PedsQL, HFS-C, and SDQ scores or anxiety levels. On the other hand, their TIR exceeded the advised thresholds. Parents exhibited enhanced coping abilities, which may be attributed to improved sleep quality and the capability to monitor all relevant metrics. Declarations Conflict of Interest Statement None of the contributing authors has any conflict of interest that could influence this study. Funding Statement This scholarly work was conducted without any dedicated financial support from public, private, or non-profit organizations. Author Disclosures All contributing authors have acknowledged accountability for the manuscript's full content and have greenlit the submission for publication. Informed Consent Consent in written form has been secured from each participant following a thorough explanation of the study's objectives and methodology. Ethical Considerations Ethical clearance was officially received from the Ege University Ethics Committee (Approval No. 21-6.1T/71. The study was conducted in full compliance with the principles of the “Declaration of Helsinki” and with laws and regulations. Animal Testing Statement Not Applicable. References Maahs DM, West NA, Lawrence JM, Mayer-Davis EJ (2010) Epidemiology of type 1 diabetes. Endocrinol Metab Clin North Am 39:481–497 Cox DJ, Gonder-Frederick L (1992) Major developments in behavioral diabetes research. J Consult Clin Psychol 60:628–638 Delamater AM, de Wit M, McDarby V, Malik JA, Hilliard ME (2018) Northam Eet al. 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Child Psychiatry Hum Dev 48:922–933 Krause KR, Chung S, Adewuya AO et al (2021) International consensus on a standard set of outcome measures for child and youth anxiety, depression, obsessive-compulsive disorder, and post-traumatic stress disorder. Lancet Psychiatry 8(1):76–86 Silva JD, Lepore G (2022) Battelino Tet al.Real-World Performance of the MiniMed™ 780G System: First Report of Outcomes from 4120 Users. Diabetes Technol Ther 24(2):113–119 Castañeda J, Mathieu C, Aanstoot HJ et al (2022) Predictors of time in target glucose range in real-world users of the MiniMed 780G system. Diabetes Obes Metab 24(11):2212–2221 Arrieta A, Battelino T et al Comparison of MiniMed 780G system performance in users aged younger and older than 15 years: Evidence from 12 870 real-world users Dantzer C, Swendsen J, Maurice-Tison S, Salamon R Anxiety and depression in juvenile diabetes: a critical review. 2003. Clin Psychol Rev 23: 787–800 Reynolds KA (2011) Helgeson vs. Children with diabetes compared to peers: depressed? Distressed? A meta-analytic review. Ann Behav Med 42:29–41 Kristensen LJ et al (2014) Symptoms of Emotional, Behavioral, and Social Difficulties in the Danish Population of Children and Adolescents with Type 1 Diabetes – Results of a National Survey. PLoS ONE 9(5):e97543 Boogerd EA et al (2015) Assessment of psychosocial problems in children with type 1 diabetes and their families: the added value of using standardized questionnaires in addition to clinical estimations of nurses and pediatricians. J Clin Nurs 24(15–16):2143–2151 Abraham MB, de Bock M, Smith GJ et al (2021) Effect of a hybrid closed-loop system on glycemic and psychosocial outcomes in children and adolescents with type 1 diabetes: a randomized clinical trial. JAMA Pediatr 175:1227–1235 E Silina (2022) Mar Prevalence of anxiety and depression symptoms in adolescents with Type 1 diabetes (T1D) and their parents. Nord J Psychiatry. 31;1. Beato-Víbora PI, Gallego-Gamero F, Lazaro-Martín L, Romero-Pérez MDM, Arroyo-Díez FJ (2020) Prospective Analysis of the Impact of Commercialized Hybrid Closed-Loop System on Glycemic Control, Glycemic Variability, and Patient-Related Outcomes in Children and Adults: A Focus on Superiority Over Predictive Low-Glucose Suspend Technology. Diabetes Technol Ther 22:912–919 [PubMed] [CrossRef] [Google Scholar] Alvarado-Martel D, Velasco R, Sánchez-Hernández RM, Carrillo A, Nóvoa FJ, Wägner AM (2015) Quality of life and type 1 diabetes: a study assessing patients' perceptions and self-management needs. Patient Prefer Adherence 9:1315–1323 Published 2015 Sep 14. 10.2147/PPA.S87310 Svedbo Engström M, Leksell J, Johansson U-B, Borg S, Palaszewski B, Franzén S, Gudbjörnsdottir S, Eeg-Olofsson K (2019) Health-related quality of life and glycaemic control among adults with type 1 and type 2 Diabetes – a nationwide cross-sectional study. Health Qual Life Outcomes 17(141):1–11 Garza KP, Jedraszko A, Weil LEG et al (2018) Automated Insulin Delivery Systems: Hopes and Expectations of Family Members. Diabetes Technol Ther 20(3):222–228. 10.1089/dia.2017.0301 Barnard KD, Wysocki T, Thabit H, Evans ML, Amiel S, Heller S et al (2015) Psychosocial aspects of closed-and open-loop insulin delivery: closing the loop in adults with type 1 diabetes in the home setting. Diabet Med 32:601–608 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 24 Apr, 2024 Read the published version in European Journal of Pediatrics → Version 1 posted Editorial decision: Revision requested 24 Feb, 2024 Reviews received at journal 22 Feb, 2024 Reviewers agreed at journal 15 Feb, 2024 Reviewers invited by journal 15 Feb, 2024 Editor assigned by journal 15 Feb, 2024 Submission checks completed at journal 15 Feb, 2024 First submitted to journal 06 Feb, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3933235","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":273034555,"identity":"b9784a24-54fe-4b90-9dd2-d0e591af1d0c","order_by":0,"name":"Arzu Jalilova","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAq0lEQVRIiWNgGAWjYDCCAxBKjoGBsfEASVqMgVoaSNOS2IBgEwB8tw8wfq74czh9bfvhhgOMew4T1iJ5LoFZ8gzP4dxtZxKBDntGhBaDM0BtDRJALQdAWg4Qp4X5Z4PB4XSz8w+J18Im2ZBwOMHsBrG2SAK1WDYcSDfcdgNoS8KBdMJa+IAOu9nwx1re7Hz6wwcfDlgT1sLAwP8BwU4gRsMoGAWjYBSMAsIAAFMHQlZYJssAAAAAAElFTkSuQmCC","orcid":"","institution":"Department of Pediatric Endocrinology, Faculty of Medicine, Ege University","correspondingAuthor":true,"prefix":"","firstName":"Arzu","middleName":"","lastName":"Jalilova","suffix":""},{"id":273034556,"identity":"8e4f6182-09fb-4210-bc03-fb401fedb896","order_by":1,"name":"Birsen Şentürk Pilan","email":"","orcid":"","institution":"Department of Child and Adolescent Psychiatry, Faculty of Medicine, Ege University","correspondingAuthor":false,"prefix":"","firstName":"Birsen","middleName":"Şentürk","lastName":"Pilan","suffix":""},{"id":273034557,"identity":"75035b58-b13c-47b4-97b1-04bb7a340437","order_by":2,"name":"Günay Demir","email":"","orcid":"","institution":"Department of Pediatric Endocrinology, Faculty of Medicine, Ege University","correspondingAuthor":false,"prefix":"","firstName":"Günay","middleName":"","lastName":"Demir","suffix":""},{"id":273034558,"identity":"58438eed-5eaf-426c-ae7d-ac5f4f3b665d","order_by":3,"name":"Burcu Özbaran","email":"","orcid":"","institution":"Department of Child and Adolescent Psychiatry, Faculty of Medicine, Ege University","correspondingAuthor":false,"prefix":"","firstName":"Burcu","middleName":"","lastName":"Özbaran","suffix":""},{"id":273034559,"identity":"4044d491-108b-4119-8ef8-1e5f55d4aa9c","order_by":4,"name":"Hanife Gul Balkı","email":"","orcid":"","institution":"Department of Pediatric Endocrinology, Faculty of Medicine, Ege University","correspondingAuthor":false,"prefix":"","firstName":"Hanife","middleName":"Gul","lastName":"Balkı","suffix":""},{"id":273034560,"identity":"458b1e7c-ddac-4b5b-8176-f518b5d8e1a0","order_by":5,"name":"Emrullah Arslan","email":"","orcid":"","institution":"Department of Pediatric Endocrinology, Faculty of Medicine, Ege University","correspondingAuthor":false,"prefix":"","firstName":"Emrullah","middleName":"","lastName":"Arslan","suffix":""},{"id":273034561,"identity":"34668a88-bc54-4b7f-94e6-911437472d84","order_by":6,"name":"Sezen Gökcen Köse","email":"","orcid":"","institution":"Department of Child and Adolescent Psychiatry, Faculty of Medicine, Ege University","correspondingAuthor":false,"prefix":"","firstName":"Sezen","middleName":"Gökcen","lastName":"Köse","suffix":""},{"id":273034562,"identity":"9833958c-9cd2-4ffb-9282-4c06836448d8","order_by":7,"name":"Samim Özen","email":"","orcid":"","institution":"Department of Pediatric Endocrinology, Faculty of Medicine, Ege University","correspondingAuthor":false,"prefix":"","firstName":"Samim","middleName":"","lastName":"Özen","suffix":""},{"id":273034563,"identity":"66fce0dc-1446-4a26-a0f4-a2952b19d5c5","order_by":8,"name":"Şükran Darcan","email":"","orcid":"","institution":"Department of Pediatric Endocrinology, Faculty of Medicine, Ege University","correspondingAuthor":false,"prefix":"","firstName":"Şükran","middleName":"","lastName":"Darcan","suffix":""},{"id":273034564,"identity":"d556ab78-5de2-4c17-b481-65ee2b4b0ee2","order_by":9,"name":"Damla Gökşen","email":"","orcid":"","institution":"Department of Pediatric Endocrinology, Faculty of Medicine, Ege University","correspondingAuthor":false,"prefix":"","firstName":"Damla","middleName":"","lastName":"Gökşen","suffix":""}],"badges":[],"createdAt":"2024-02-06 08:01:09","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3933235/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3933235/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00431-024-05551-1","type":"published","date":"2024-04-25T00:47:43+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":55698468,"identity":"8c03365a-a501-48b3-937e-c9e982b4eec7","added_by":"auto","created_at":"2024-05-02 02:34:52","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":760522,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3933235/v1/641f0651-e57f-41d1-be25-51eb7cd6dc2f.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":" The Psychosocial Outcomes of Advanced Hybrid Closed-Loop System in Children and Adolescents with Type 1 Diabetes","fulltext":[{"header":"Introduction","content":"\u003cp\u003eType 1 diabetes (T1D) is one of childhood and adolescence's most common chronic endocrine disorders, significantly impacting their physical and emotional development (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). T1D patients must make significant lifestyle adjustments to meet their daily exogenous insulin needs, including checking blood glucose levels regularly and managing dietary consumption. Difficulties in managing glycemic control negatively affect psychological health, leading to poor glycemic control and quality of life (QoL) (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe studies indicated that automated insulin delivery (AID) systems improve glycemic control in individuals with T1D. These benefits are universally observed across different age and gender groups and are not influenced by the duration of T1D, previously used insulin delivery methods, or initial glycated hemoglobin (HbA1c) levels (\u003cspan additionalcitationids=\"CR7 CR8\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe AID systems currently available on the market require users to manually enter the insulin doses at mealtime and indicate physical activity. Meanwhile, the system autonomously adjusts insulin delivery (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Compared to a number of studies on the glycemic outcomes of AID systems in this patient group, there are only a handful of studies on their psychosocial impact. Specifically, there are even fewer studies on the impact of AID systems on the QoL and emotional well-being of both children and their parents, including the quality and duration of sleep. Although the patient-reported outcomes on the impact of AID systems on QoL vary, the overarching consensus is that AID systems often improve QoL (\u003cspan additionalcitationids=\"CR12\" citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Additionally, some studies have reported a significant reduction in the fear of hypoglycemia (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e), while others have reported a decrease in diabetes-related stress and an improvement in sleep quality with the use of AID systems (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIt's important to note that Advanced Hybrid Closed-Loop (AHCL) systems do not fully automate every aspect of diabetes management. Therefore, human and psychosocial factors continue to play a significant role in effectively utilizing these systems. In this context, the objective of this study is to describe the experience of children with T1D on Minimed 780G systems in terms of diabetes difficulties, depression, anxiety, fear of hypoglycemia, and QoL.\u003c/p\u003e"},{"header":"Material and Methods","content":"\u003cp\u003eThe population of this prospective interventional study consisted of children and adolescents aged 6\u0026ndash;18 years who used MiniMed\u0026trade; 780 G (Medtronic, Northridge, CA, USA) and their parents or caregivers. The study protocol was approved by the Ege University Ethics Committee (Approval No. 21-3.1T/23. Participants and their parents or caregivers were briefed on the objectives and methodology of the study. Informed consent was obtained from each patient included in the study.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Protocol\u003c/h2\u003e \u003cp\u003eParticipants were first given a tutorial in order to familiarize themselves with the manual mode of the system and its various functionalities. Auto-Mode was activated three and ten days after the tutorial in those using the Minimed 640G and MDI, respectively. Pediatric psychiatrists assessed all T1D patients using the Schedule for Affective Disorders and Schizophrenia for School-Age Children/Present and Lifetime Turkish Version (K-SADS-PL-T) (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) based on the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e) to rule out psychiatric conditions.\u003c/p\u003e \u003cp\u003eAll subjects, along with their parents or caregivers, were asked to fill out several validated questionnaires including the Pediatric Quality of Life Inventory (PedsQL) 3.0diabetes module (\u003cspan additionalcitationids=\"CR20\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e), Strengths and Difficulties Questionnaire (SDQ) (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e), Hypoglycemia Fear Survey for Children (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e), The Revised Child Anxiety and Depression Scale (R-CADS) (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e), and the AHCL system-specific DTSEQ satisfaction and expectation survey. These assessments were completed before the use of the AID system at the baseline and then again after six months of AHCL system use.\u003c/p\u003e \u003cp\u003eThe SDQ focuses on both positive attributes and challenges in children, consisting of items that evaluate prosocial behavior and various difficulties (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). SDQ is divided into five categories: \"Conduct Problems,\" \"Hyperactivity and Inattention,\" \"Emotional Symptoms,\" \"Peer Problems,\" and \"Prosocial Behaviors.\" The aggregation of scores in different subsections enables the calculation of \"internalizing\" and \"externalizing\" problem indices (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). Scoring tiers for the SDQ are categorized as normal (\u0026lt;\u0026thinsp;15), subclinical (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e), and clinical (\u0026gt;\u0026thinsp;16) psychosocial functioning.\u003c/p\u003e \u003cp\u003eThe R-CADS is used for the self-assessment of anxiety and depression symptoms in children and adolescents. R-CADS consists of 47 items in six subscales, addressing various forms of anxiety and depression disorders, such as separation anxiety and social phobia. R-CADS-P, the version of R-CADS for use by parents, evaluates anxiety and depression symptoms in children and adolescents based on parental observations (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe Hypoglycemia Fear Survey for Children (HFS-C) comprises 24 items in behavior and worriedness subscales and additional items related to special situations related to hypoglycemia. Items are scored on a scale from 0 (never) to 4 (almost always). The total score obtained from HFS-C ranges from 24 to 120 (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe PedsQL 3.0 diabetes module aims to assess Health-Related QoL (HRQOL) specific to diabetes. PedsQL comes in two versions based on age groups, comprising five subscales that cover various dimensions of diabetes care, including diabetes symptoms, treatment barriers, and treatment adherence (\u003cspan additionalcitationids=\"CR20\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe DTSEQ satisfaction and expectation survey was specifically formulated for use with the \"Minimed 780 G\" system, utilizing the \"Davis Technique\" for content validity assurance. The total score that can be obtained from the AHCL system-specific DTSEQ satisfaction and expectation survey ranges from 21 to 105.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eStatistical Analysis\u003c/strong\u003e \u003cp\u003eSPSS 22.0 (Statistical Product and Service Solutions for Windows, Version 22.0, IBM Corp., Armonk, NY, U.S., 2013) software package was used to conduct the statistical analyses of the collected data. The normal distribution characteristics of the variables on all metrics related to system usage, glycemic control, and psychosocial factors were analyzed using the Kolmogorov-Smirnov test. Additionally, the Shapiro-Wilk test was used to confirm the normal distribution assumptions of quantitative data within each subset of participants. Significance in statistical variation was ascertained through multiple tests. Accordingly, the student\u0026rsquo;s t-test and the Mann-Whitney U test were used for normally and non-normally distributed numerical data, respectively. On the other hand, cross-tabulation, Pearson's chi-square test, and Fisher's exact test were used to compare the categorical data. Probability (\u003cem\u003ep\u003c/em\u003e) statistics of \u0026le;\u0026thinsp;0.05 were deemed to indicate statistical significance. Pearson\u0026rsquo;s correlation coefficient was used to assess the correlations between normally distributed data, whereas Spearman's rank correlation coefficient was used to assess the correlations between nonparametric data.\u003c/p\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eOf the 60 children and adolescents with T1D, for whom the AHCL system was utilized, one patient was excluded from the study due to a psychiatric diagnosis at the beginning, and 13 were lost to follow-up.46 (67%) patients completed the 6th-month follow-up. However, four of these patients refused to fill out the sixth-month survey. In the end, 41 patients, 23 female and 18 male, were included in the study sample. The mean age of the study sample was 12.5\u0026thinsp;\u0026plusmn;\u0026thinsp;3.2 (min. 6.7, max. 18) years. The mean duration of T1D in these patients was 5.5\u0026thinsp;\u0026plusmn;\u0026thinsp;5.0 years. None of the children was on psychotropic medication during the study period. Of the 41 patients, 21 were on the Minimed 640G system, 19 on multiple daily insulin therapy (MDI), and 1 on the MiniMed Paradigm Veo pump (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Time-in-range (TIR) (70\u0026ndash;180 mg/dL) increased from 76.9\u0026thinsp;\u0026plusmn;\u0026thinsp;9% at the baseline to 80.4\u0026thinsp;\u0026plusmn;\u0026thinsp;5% after six months of AHCL system use (p\u0026thinsp;=\u0026thinsp;0.03). Mean HbA1c decreased from 7.1% \u0026plusmn; 0.7% at the baseline to 6.8% \u0026plusmn;0.8% after six months of AHCL system use (p\u0026thinsp;=\u0026thinsp;0.03).\u003c/p\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eSDQ Scores\u003c/h2\u003e \u003cp\u003eThe mean total SDQ score was 24 at baseline and 22 after six months of AHCL system use (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). There was no significant difference between baseline and sixth-month total SDQ and SDQ subscale scores.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDemographic information of the participants\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (y)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12.5 years\u0026thinsp;\u0026plusmn;\u0026thinsp;3.2\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGender (Male/Female)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18/23\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiabetes duration (y)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5.5\u0026thinsp;\u0026plusmn;\u0026thinsp;5.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBasal HbA1c\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7.1% \u0026plusmn; 0.7%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBasal Therapy\u003c/p\u003e \u003cp\u003eMinimed VEO pump\u003c/p\u003e \u003cp\u003eMinimed 640 pump\u003c/p\u003e \u003cp\u003eMDI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e21\u003c/p\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of SDQ outcomes between baseline and 6th month\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSDQ\u003c/p\u003e \u003cp\u003e(children and parents)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eBaseline\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c8\" namest=\"c5\"\u003e \u003cp\u003e6th month\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eChildren\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMinimum\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMaximum\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eMinimum\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eMaximum\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003ep\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEmotional symptoms\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.50\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHyperactivity/inattention\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.06\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConduct problems\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.30\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePeer relationship problems\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.30\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProsocial behavior\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.60\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal difficulty score\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.25\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eParents\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEmotional symptoms\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.45\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHyperactivity/inattention\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.10\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConduct problems\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.08\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePeer relationship problems\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.40\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProsocial behavior\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.10\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal difficulty score\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.25\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eR-CADS and R-CADS-PScores\u003c/h2\u003e \u003cp\u003eThere was no significant difference between baseline and sixth-month R-CADS scores. On the other hand, R-CADS-P scores revealed that the total depression and anxiety scores of the children and adolescents decreased at the sixth month compared to baseline (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of R-CADS (children and parents) outcomes between baseline and 6th month\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eR-CADS\u003c/p\u003e \u003cp\u003e(children and parents)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eBaseline\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c8\" namest=\"c5\"\u003e \u003cp\u003e6th month\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eChildren\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003ep\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal anxiety score\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e76\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.50\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMajor depression scale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.30\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eParents\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal anxiety score\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.04\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMajor depression scale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.03\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003ePedsQL 3.0 Diabetes Module Scores\u003c/h2\u003e \u003cp\u003eThere was no significant difference between baseline and sixth-month data in PedsQL3.0 Diabetes Module scores (p\u0026thinsp;=\u0026thinsp;0.26) (Tables\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e and \u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePediatric Quality of Life Inventory (PedsQL) 3.0 Diabetes Module outcomes between baseline and 6th month\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePedsQL\u003c/p\u003e \u003cp\u003e(child and parents)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eBaseline\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c8\" namest=\"c5\"\u003e \u003cp\u003e6th month\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eChildren\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003ep\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiabetes symptoms\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.65\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTreatment barriers\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.40\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTreatment adherence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.30\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWorry\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.20\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCommunication\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.10\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal score\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e89\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e112\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e83\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e108\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.25\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eParents\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiabetes symptoms\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e35.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.95\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTreatment barriers\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.60\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTreatment adherence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e21.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.40\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWorry\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.40\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCommunication\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.50\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal score\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e87\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e108\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e108\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.80\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDiabetes-related quality of life for youth short form outcomes between baseline and 6th month\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDQOLY-SF\u003c/p\u003e \u003cp\u003e(adolescent)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eBaseline\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c8\" namest=\"c5\"\u003e \u003cp\u003e6th month\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eChildren\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003ep\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eImpact of symptom (\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u0026thinsp;3)\u003c/span\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.20\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eImpact of treatment (\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u0026thinsp;3)\u003c/span\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.45\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eImpact on activities (\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u0026thinsp;5)\u003c/span\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.15\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParents' issues (\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u0026thinsp;3)\u003c/span\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.20\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWorries (\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u0026thinsp;7)\u003c/span\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.60\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHealth Perception\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.40\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal score\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e68\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.70\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eHFS-C Scores\u003c/h2\u003e \u003cp\u003eThe median total HFS-C score decreased from 40 (min. 24, max. 102) at the baseline to 38 (min. 16, max. 90) at the sixth month (p\u0026thinsp;=\u0026thinsp;0.56) (Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab6\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 6\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eHypoglycemia Fear Scale for Children outcomes between baseline and 6th month\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHFS\u003c/p\u003e \u003cp\u003e(child)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eBaseline\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c8\" namest=\"c5\"\u003e \u003cp\u003e6th month\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eChildren\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003ep\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSpecific situations\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.10\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGeneral Fears\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.60\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBehavior\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.95\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal score\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e102\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003e0.55\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eAHCL System-Specific DTSEQ Satisfaction and Expectation Survey Scores\u003c/h2\u003e \u003cp\u003eThe AHCL system-specific DTSEQ satisfaction and expectation survey scores were within the typical range at the baseline. There was an increase, albeit insignificant, in the total score in the sixth month (baseline mean total score: 75\u0026thinsp;\u0026plusmn;\u0026thinsp;13 vs. sixth month mean total score: 79\u0026thinsp;\u0026plusmn;\u0026thinsp;12; p\u0026thinsp;=\u0026thinsp;0.16).\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eA number of studies revealed that the use of MiniMed™ 780 G (Medtronic, Northridge, CA USA) in children with T1D aged 8 to 18 significantly increased TIR towards the target range of 70–180 mg/dL (\u003cspan additionalcitationids=\"CR30\" citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e–\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). However, this is the first study to date addressing the long-term psychological impact of the MiniMed™ 780 G in detail. Consequently, it was determined that the anxiety and depression levels of children and adolescents included in the study significantly decreased with the use of AHCL systems, according to their parents and caregivers.\u003c/p\u003e \u003cp\u003eThe studies on the psychosocial problems of children with T1D based on SDQ subscale scores revealed emotional and behavioral problems as their primary problems (\u003cspan additionalcitationids=\"CR33\" citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e–\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e).In contrast, a study conducted with Danish children and adolescents reported lower or comparable levels of emotional difficulties with the use of AHCL systems compared to the control group, whereas parents and caregivers of these children and adolescents reported even less favorable outcomes (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e). In a controlled study by Boogerd et al. based on SDQ scores, both children with T1D and their parents reported significantly more prosocial problems compared to the control group (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e).In contrast, a study reported significant improvements in satisfaction with the use of HCL Minimed™ 670G (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e). The improvement in outcomes with the use of HCL Minimed™ 670G can be due to reduced worriedness, increased confidence, and trust in the system with improved glycemic control. In comparison, in this study, the baseline SDQ scores revealed high total difficulty scores, whereas the SDQ subscale scores indicated symptoms of hyperactivity/inattention and peer relationship problems. These results did not improve after six months of AHCL system use.\u003c/p\u003e \u003cp\u003eA recent review by Silina et al. showed that adolescents with T1D and their parents were more predisposed to anxiety and depression symptoms than healthy somatic children and their parents (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e).In a four-week study conducted with 13 young children aged 7 to 10, the insulin pump therapy was changed to an AID system. Consequently, it was determined that the AID system significantly reduced the depression levels of young children as well as their parents. In addition, in the said study, it was observed that children's depression scores (CDI-2) with Tandem Control IQ did not decrease significantly compared to sensor-augmented pump therapy (SAP)at the end of 4 weeks (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). In comparison, in this study, the total R-CADS and R-CADS subscale scores of the children and adolescents with T1D were within the normal range both at the baseline and after six months of AHCL system use, and there were no significant differences between the baseline and sixth-month total R-CADSand R-CADSsubscale scores related to anxiety and depression. On the contrary, the sixth-month R-CADS-P scores were significantly better compared to the baseline R-CADS-P, indicating better depression and anxiety outcomes. The absence of diabetes-related depression and anxiety symptoms in children and adolescents with T1D included in this study at the baseline may be attributed to good metabolic control.\u003c/p\u003e \u003cp\u003eIn terms of QoL, the mean total PedsQL scores of the children and adolescents with T1D included in this study were high at the baseline and did not change after six months of AHCL system use. Similarly, Wheeler et al. did not report any significant difference in QoL scores of T1D patients with a mean age of 23 years between the use of Minimed™ 780G, SAP, and predictive low glucose suspend pump(PLGS) therapy (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e).In contrast, Beato-Vibora PI. reported a significant improvement in QoL scores after three months of Minimed™ 670Guse (\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e). Bisio et al.(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) also reported significant improvements in every measure of QoL in children with T1D with the use of AID compared to SAP. However, in the same study, the parents of these children did not report significant improvements in QoL or the emotional well-being of their children with the use of AID. In comparison, in this study, the QoL of the patients with T1D was high at the baseline, possibly due to good metabolic control. As demonstrated in previous studies, good glycemic control leads to a good QoL (\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e, \u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e). The cultural and social factors related to family support and the fact that 53% of the patients were using a pump before they were on a flexible nutrition model might also have contributed to our patients coping with diabetes-related problems.\u003c/p\u003e \u003cp\u003eThe total AHCL system-specific expectation and satisfaction survey scores have improved, albeit not significantly, between the baseline and after six months of AHCL system use. This improvement might be due to decreased worriedness, increased confidence and trust in the system, improved glycemic control, and enhanced diabetes management. This is an important finding, given that although users find AID systems helpful in terms of daily use, they report difficulties in connecting the system. Wheeler et al. found no significant difference between AID and SAP + PLGM in terms of treatment satisfaction based on the responses of diabetic adolescents and their parents (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). In another study evaluating the hopes and expectations of family members on AID systems, it was reported that there is an expectation that this diabetes technology will alleviate diabetes-specific anxiety and burden in individuals with diabetes and other family members and that this system can reduce daily stress and, most importantly, improve family relationships (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIn this study, no significant difference was found between baseline and sixth-month HFS-C scores. Fear of hypoglycemia, particularly night fear, is common among diabetic patients and their families. Bisio et al. reported that Tandem Control IQ reduced hypoglycemia fear in caregivers compared to SAP therapy over one month (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Although no significant difference was found in the follow-up, the decrease in the total score may reflect the decrease in fear and anxiety of hypoglycemia. Technology alarms can also cause increased levels of extra anxiety, becoming annoying, especially at night. As a matter of fact, Barnard et al. reported that alarms were a problem for some(n = 13)participants, noting that they were more irritating, especially when they were causing recurring sleepless nights and other family members to wake up (\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eAlthough AID systems improved glycemic control in our study, the decrease observed in the anxiety and depression levels of children and adolescents with T1D under real-life conditions in the long term was only from the perspective of parents and caregivers.\u003c/p\u003e \u003cp\u003eOur study has some limitations. Our study was conducted with a relatively small number of patients and there was no control group.\u003c/p\u003e \u003cp\u003eIn conclusion, AHCL insulin delivery represents the latest technology in the treatment of T1D. However, this study’s findings revealed the need for further research to determine the AID systems' long-term psychological and physical benefits.\u003c/p\u003e "},{"header":"Concluding Remarks","content":"\u003cp\u003eTo the best of our knowledge, this is the first study to date to investigate in detail the psychological impact of AHCL systems on T1D patients and their parents. Even though such technologies, i.e., Minimed™ 780G systems, give flexibility to diabetic patients in their daily living activities, they did not improve their PedsQL, HFS-C, and SDQ scores or anxiety levels. On the other hand, their TIR exceeded the advised thresholds. Parents exhibited enhanced coping abilities, which may be attributed to improved sleep quality and the capability to monitor all relevant metrics.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eConflict of Interest Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNone of the contributing authors has any conflict of interest that could influence this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis scholarly work was conducted without any dedicated financial support from public, private, or non-profit organizations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Disclosures\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll contributing authors have acknowledged accountability for the manuscript's full content and have greenlit the submission for publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInformed Consent\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsent in written form has been secured from each participant following a thorough explanation of the study's objectives and methodology.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Considerations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical clearance was officially received from the Ege University Ethics Committee (Approval No. 21-6.1T/71. The study was conducted in full compliance with the principles of the \u0026ldquo;Declaration of Helsinki\u0026rdquo; and with laws and regulations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAnimal Testing Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot Applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eMaahs DM, West NA, Lawrence JM, Mayer-Davis EJ (2010) Epidemiology of type 1 diabetes. Endocrinol Metab Clin North Am 39:481\u0026ndash;497\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCox DJ, Gonder-Frederick L (1992) Major developments in behavioral diabetes research. J Consult Clin Psychol 60:628\u0026ndash;638\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDelamater AM, de Wit M, McDarby V, Malik JA, Hilliard ME (2018) Northam Eet al. 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Acta Diabetol 59(1):31\u0026ndash;37\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWeissberg-Benchell J, Hessler D, Fisher L, Russell SJ, Polonsky WH (2017) Impact of an automated bihormonal delivery system on psychosocial outcomes in adults with type 1 diabetes. Diabetes Technol Ther 19(12):723\u0026ndash;729\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCobry EC, Bisio A, Wadwa RP, Breton MD (2022) Improvements in parental sleep, fear of hypoglycemia, and diabetes distress with the use of an advanced hybrid closed-loop system. Diabetes Care 45(5):1292\u0026ndash;1295\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCarlson AL, Bode BW, Brazg RL et al 97-P- Safety and glycaemic outcomes of the MiniMed\u0026trade;a-HCL System in subjects with T1D. 80th ADA International Conference, June 2020, Chicago.\u0026bull;\u0026bull; 780G Pivotal Trial results that influenced CE mark approval\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N (1997) Schedule for Affective Disorders and Schizophrenia for School Age Children - Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry 36:980\u0026ndash;988\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAmerican Psychiatric Association (APA) (2000) Diagnostic and Statistical Manual of Mental Disorders, 4th edition-text revision (DSM-IV-TR). American Psychiatric Association, Washington DC\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eG\u0026ouml;kler B, \u0026Uuml;nal F, Pehlivant\u0026uuml;rk F, K\u0026uuml;lt\u0026uuml;r EC\u0026cedil; Akdemir D, Taner Y (2004) Reliability and validity of schedule for affective disorders and schizophrenia for school-age children-present and lifetime version Turkish version (K-SADS-PL-T). 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Oxid Commun 39(1\u0026ndash;II):438\u0026ndash;449\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGoodman R (2001) Psychometric properties of the Strengths and Difficulties Questionnaire. J Am Acad Child Adolesc Psychiatry 40:1337\u0026ndash;1345\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuvenir T, \u0026Ouml;zbek A, Baykara B, Arkar H, Şent\u0026uuml;rk B, İncekaş S (2008) Psychometric Properties Of The Turkish Version Of The Strengths And Difficulties Questionnaire. Turk J Child Adolesc Ment Health 15:65\u0026ndash;74\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKamps JL, Roberts MC, Varela RE (2005) Development of a new fear of hypoglycemia scale: preliminary results. 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Psychiatry Clin Psychopharmacol 27:84\u0026ndash;92\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGormez V, Kilincaslan A, Ebesutani C et al (2017) Psychometric properties of the parent version of the revised child anxiety and Depression Scale in a clinical sample of Turkish children and adolescents. Child Psychiatry Hum Dev 48:922\u0026ndash;933\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKrause KR, Chung S, Adewuya AO et al (2021) International consensus on a standard set of outcome measures for child and youth anxiety, depression, obsessive-compulsive disorder, and post-traumatic stress disorder. Lancet Psychiatry 8(1):76\u0026ndash;86\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSilva JD, Lepore G (2022) Battelino Tet al.Real-World Performance of the MiniMed\u0026trade; 780G System: First Report of Outcomes from 4120 Users. Diabetes Technol Ther 24(2):113\u0026ndash;119\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCasta\u0026ntilde;eda J, Mathieu C, Aanstoot HJ et al (2022) Predictors of time in target glucose range in real-world users of the MiniMed 780G system. Diabetes Obes Metab 24(11):2212\u0026ndash;2221\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eArrieta A, Battelino T et al Comparison of MiniMed 780G system performance in users aged younger and older than 15 years: Evidence from 12 870 real-world users\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDantzer C, Swendsen J, Maurice-Tison S, Salamon R Anxiety and depression in juvenile diabetes: a critical review. 2003. Clin Psychol Rev 23: 787\u0026ndash;800\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eReynolds KA (2011) Helgeson vs. Children with diabetes compared to peers: depressed? Distressed? A meta-analytic review. 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Patient Prefer Adherence 9:1315\u0026ndash;1323 Published 2015 Sep 14. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2147/PPA.S87310\u003c/span\u003e\u003cspan address=\"10.2147/PPA.S87310\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSvedbo Engstr\u0026ouml;m M, Leksell J, Johansson U-B, Borg S, Palaszewski B, Franz\u0026eacute;n S, Gudbj\u0026ouml;rnsdottir S, Eeg-Olofsson K (2019) Health-related quality of life and glycaemic control among adults with type 1 and type 2 Diabetes \u0026ndash; a nationwide cross-sectional study. Health Qual Life Outcomes 17(141):1\u0026ndash;11\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGarza KP, Jedraszko A, Weil LEG et al (2018) Automated Insulin Delivery Systems: Hopes and Expectations of Family Members. Diabetes Technol Ther 20(3):222\u0026ndash;228. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1089/dia.2017.0301\u003c/span\u003e\u003cspan address=\"10.1089/dia.2017.0301\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBarnard KD, Wysocki T, Thabit H, Evans ML, Amiel S, Heller S et al (2015) Psychosocial aspects of closed-and open-loop insulin delivery: closing the loop in adults with type 1 diabetes in the home setting. Diabet Med 32:601\u0026ndash;608\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"european-journal-of-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ejpe","sideBox":"Learn more about [European Journal of Pediatrics](https://www.springer.com/journal/431)","snPcode":"431","submissionUrl":"https://submission.nature.com/new-submission/431/3","title":"European Journal of Pediatrics","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Advanced Hybrid Closed-Loop, Type 1 Diabetes, Psychosocial Outcomes, Pediatric Endocrinology, Glycemic Control","lastPublishedDoi":"10.21203/rs.3.rs-3933235/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3933235/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective\u003c/strong\u003e: The study was carried out to determine the psychosocial outcomes of Advanced Hybrid Closed-Loop (AHCL) systems in children and adolescents with Type 1 Diabetes (T1D).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResearch design\u0026amp;Method\u003c/strong\u003e: The study population consisted of 60 children and adolescents with T1D.Standard clinical procedures, including both glycemic indicators, e.g., sensor-measured time within the 70–180 mg/dL range and glycated hemoglobin (HbA1c) levels, and psychosocial metrics were used for data collection. The psychosocial metrics included the Pediatric Quality of Life Inventory (PedsQL) 3.0 Diabetes Module for both children (8-12 years) and parents; the Quality of Life for Youth scale for adolescents (13-18 years); the Strengths and Difficulties Questionnaire (SDQ); the Hypoglycemia Fear Survey for Children(HFS-C); the Revised Child Anxiety and Depression Scale (R-CADS); and AHCLS-specific DTSEQ satisfaction and expectation survey. These metrics were evaluated at the baseline and after six months of AHCL use.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: Of the 60 children and adolescents with T1D for whom the AHCL system was utilized, 41 patients, 23 female and 18 male, completed the surveys. The mean age of the 41 children and adolescents that constituted the study sample was 12.5 ± 3.2 (min. 6.7, max. 18) years. The time spent within the target glycemic range, i.e., time-in-range (TIR), improved from 76.9 ± 9% at the baseline to 80.4 ± 5% after six months of AHCL system use(p=0.034). Additionally, HbA1c levels reduced from 7.1% ± 0.7% at the baseline to 6.8% ± 0.8% after six months of AHCL system use(P=0.031). The most notable decline in HbA1c was observed in participants with higher baseline HbA1c levels. All patients’ HFS-C and AHCL system-specific DTSEQ satisfaction and expectation survey scores were within the normal range at the baseline and remained unchanged during the follow-up period. No significant difference was found in the R-CADS scores of children and adolescents between baseline and after six months of AHCL system use. However, there was a significant decrease in the R-CADS scores of children and adolescents administered by their parents. Patients’ PedsQL scores were high both at the baseline and after six months of AHCL system use. The evaluation of children and adolescents with SDQ revealed high overall difficulty scores at the baseline. On the other hand, no significant improvement was achieved in SDQ scores after six months of AHCL system use compared to baseline.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions:\u003c/strong\u003e This is the first study to investigate in detail the psychosocial outcomes of AHCL system use in T1D patients and their parents. Although state-of-the-art technologies such as AHCL provide patients with more flexibility in their daily lives and information about glucose fluctuations, the AHCL resulted in a TIR above the recommended target range without a change in QOL, HFS-C, SDQ, and R-CADS scores. The scores obtained from the R-CADS conducted by the parents of their children indicated that the use of pumps caused a psychological improvement in the long term, with a significant decrease in the R-CADS scores of the children and adolescents with T1D. Further studies are needed to elucidate the reasons for AHCL discontinuation and determine intervention strategies.\u003c/p\u003e","manuscriptTitle":" The Psychosocial Outcomes of Advanced Hybrid Closed-Loop System in Children and Adolescents with Type 1 Diabetes","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-02-16 12:06:00","doi":"10.21203/rs.3.rs-3933235/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-02-24T07:51:27+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-02-22T15:16:14+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"6c4df294-5bb0-4874-83c4-e4ab318f0d24","date":"2024-02-15T12:22:38+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-02-15T12:19:24+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-02-15T08:49:26+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-02-15T08:48:33+00:00","index":"","fulltext":""},{"type":"submitted","content":"European Journal of Pediatrics","date":"2024-02-06T08:00:02+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"european-journal-of-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ejpe","sideBox":"Learn more about [European Journal of Pediatrics](https://www.springer.com/journal/431)","snPcode":"431","submissionUrl":"https://submission.nature.com/new-submission/431/3","title":"European Journal of Pediatrics","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"540d6519-4283-4591-a5d1-3555ce98c30b","owner":[],"postedDate":"February 16th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-05-02T00:47:43+00:00","versionOfRecord":{"articleIdentity":"rs-3933235","link":"https://doi.org/10.1007/s00431-024-05551-1","journal":{"identity":"european-journal-of-pediatrics","isVorOnly":false,"title":"European Journal of Pediatrics"},"publishedOn":"2024-04-25 00:47:43","publishedOnDateReadable":"April 25th, 2024"},"versionCreatedAt":"2024-02-16 12:06:00","video":"","vorDoi":"10.1007/s00431-024-05551-1","vorDoiUrl":"https://doi.org/10.1007/s00431-024-05551-1","workflowStages":[]},"version":"v1","identity":"rs-3933235","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3933235","identity":"rs-3933235","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}
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