Study protocol of translation into Spanish and cross-cultural adaptation and validation of the problem areas in diabetes-Pediatric version (PAID-Peds) survey.

AIM: The metabolic and psychological management of paediatric type 1 diabetes mellitus (T1DM) can be challenging over time given that T1DM may cause a negative emotional burden and, consequently, result in poor metabolic control of the disease. The objectives of this study are to translate the Problem Area in Diabetes Survey-Pediatric version (PAID-Peds) into Spanish, adapt it culturally and validate it. DESIGN: Multicenter cross sectional study. METHODS: 636 patients aged 8-17 years, diagnosed with T1DM, under treatment with insulin and follow-up at the Miguel Servet University Hospital in Zaragoza (Aragón, Spain), the Ramón y Cajal University Clinical Hospital in Madrid (Spain) and at the Sant Joan de Déu Hospital in Barcelona (Catalonia, Spain) between 1 January 2023 and 31 December 2024 will be included. This study will consist of two phases: (1) Translation and cultural adaptation of the original PAID-Peds® survey into Spanish following eight steps; (2) Validation of the Spanish version of the PAIS-Peds® survey. The statistical analysis will be performed using Jamovi® 2.1.23. The reliability or internal consistency will be calculated using Cronbach's alpha index (considering an index higher than 0.8 to be good) and the test-retest will be evaluated using the intraclass correlation coefficient. For validity, confirmatory factor analysis will be calculated. This study has been approved by the ethics and research committees at each centre. RESULTS: The translation and validation into Spanish language of the Problem Area in Diabetes Survey-Pediatric version will be feasible, valid and reliable to detecting the youth-perceived burden of T1DM. Therapeutic education in diabetes-recommended by the WHO and the Diabetes Education Study Group-has shown encouraging results in glycaemia and psychosocial and behavioural factors in T1DM.

Translation and psychometric evaluation of the Spanish version of the problem areas in diabetes-pediatric version (PAID-Peds) survey.

BACKGROUND: Metabolic control and psychological management of paediatric type 1 diabetes mellitus (T1DM) can be challenging over time. Development of an instrument to assess the youth-reported burden could aid in preventing T1DM-associated diseases. METHODS: The aim of this study was to translate and validate the Spanish version of the Problem Area in Diabetes Survey-Pediatric version (PAID-Peds). A multicentre, cross-sectional translation and linguistic validation study was performed on a sample of 30 participants aged 8-17 years with a minimum 1-year history of T1DM diagnosed at the Miguel Servet University Hospital in Zaragoza (Aragon, Spain), Ramón y Cajal University Clinical Hospital in Madrid (Spain), and Sant Joan de Déu Hospital in Barcelona (Catalonia, Spain). The qualitative validation consisted of translation into Spanish and back-translation into English of the Paid-Peds survey and subsequent administration to the sample population. Data were gathered on parameters related to sociodemographic characteristics and metabolic control. Validity, feasibility, and test-retest reliability were evaluated. Internal consistency was determined using Cronbach's alpha coefficient, test-retest reliability by means of interclass correlation, and paired samples using the Wilcoxon W-test. The study was approved by the ethics and research committees at each participating centre. RESULTS: The study assessed 30 children (46.7% female) with an average age of 13.33 ± 2.98 years; mean age at onset was 5.70 ± 3.62 years, and the mean disease duration was 7.63 ± 4.36 years. The mean score on the PAID-Peds survey was 42.88 ± 17.85. Cronbach's alpha coefficient was 0.90. Test-retest reliability measured by interclass correlation coefficient was 0.8 (95% CI: 0.63-0.90). No significant differences in total scores were found between test and retest (Wilcoxon W-test: 289; p = 0.051). CONCLUSIONS: The Spanish version of the PAID-Peds survey is a feasible, valid, and reliable instrument to assess the youth-perceived burden of T1DM.

Effectiveness of MiniMed 640G with SmartGuard® System for prevention of hypoglycemia in pediatric patients with type 1 diabetes mellitus. / Efectividad del sistema MiniMed 640G con SmartGuard® para la prevención de hipoglucemia en pacientes pediátricos con diabetes mellitus tipo 1.

INTRODUCTION/AIMS: Treatment with the MiniMed 640G-SmartGuard® system (640G-SG, sensor-augmented insulin pump system with low predicted glucose suspension feature) has been shown to decrease risk of hypoglycemia without altering metabolic control in patients with T1DM. The study purpose was to assess the impact of 640G-SG on hipoglycemia frequency and on metabolic control in a pediatric population with T1DM. PATIENTS/METHODS: A retrospective study on 21 children treated with 640G-SG. HbA1C, mean blood glucose (mg/dl), glucose variation coefficient, frequency of hypoglycemia (<70mg/dl) and hyperglycemia (>180mg/dl), daily capillary blood glucose measurements, ketosis/diabetic ketoacidosis, and severe hypoglycemic episodes were analyzed and compared before and during use of the system. Fasting blood glucose, frequency of sensor use and number and duration of system suspension events were also assessed in the last month of use of the system. RESULTS: All patients used the system continuously (5.0±2.1 months), with a median sensor use of 92%. Significant decreases were seen in hypoglycemia frequency (10.4±5.2% to 7.6±3.3%, p=.044) and number of capillary blood glucose measurements (11.3±2,2 to 8.1±2,1, p<.001), and there was no increase in hyperglycemia frequency (p=.65). Mean system suspension time was 3.1±1.2hours/day (37.3% of overnight stops). Changes in HbA1c, mean blood glucose, and variation coefficient were not significant. No patient experienced diabetic ketoacidosis or severe hypoglycemia. CONCLUSIONS: The sensor-augmented pump with the predictive low glucose suspension management system, as implemented in the 640G-SG system, can help avoid risk of hypoglycemia without significantly affecting metabolic control or causing diabetic ketoacidosis, and decrease the burden of additional capillary blood glucose measurements in our pediatric cohort.

Impact of diabetes education on type 1 diabetes mellitus control in children. / Impacto de la educación diabetológica en el control de la diabetes mellitus tipo 1 en la edad pediátrica.

INTRODUCTION: Diabetes education is an essential tool to achieve treatment objectives in type1 diabetes mellitus (T1DM). The aim of this study was to determine if understanding of diabetes by caregivers/patients or sociodemographic factors affect blood glucose control in children and adolescents with T1DM. PATIENTS AND METHODS: The level of knowledge of 105 caregivers of children and adolescents with T1DM was assessed using a survey adapted to the type of treatment used (multiple dose insulin [MDI] or continuous subcutaneous insulin infusion [CSII]). Mean HbA1c levels in the previous year was considered as metabolic control marker. RESULTS: Mean HbA1c levels were similar in both treatment groups, with slightly higher values in children over 12years of age. Patients on CSII had a longer time since disease onset and had poorer results, maybe because the items were more difficult due to the higher level of knowledge required for this treatment modality (P=.005). Caregivers with lower educational levels achieved poorer scores in the survey, but mean HbA1c levels of their children were lower, probably because of their greater involvement in disease care. CONCLUSIONS: The level of knowledge of caregivers and/or patients with T1DM was high, and this was associated to good metabolic control. Studies to assess the impact of caregiver knowledge on metabolic control of children are needed.