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See detailImpact of continuous glucose monitoring on quality of life, treatment satisfaction, and use of medical care resources: analyses from the SWITCH study
Hommel, E; Olsen, B; Battelino, T et al

in Acta Diabetologica (2014), 51(5), 845-851

To investigate the impact of continuous glucose monitoring (CGM) on health-related quality of life (HRQOL), treatment satisfaction (TS) medical resource use, and indirect costs in the SWITCH study. SWITCH ... [more ▼]

To investigate the impact of continuous glucose monitoring (CGM) on health-related quality of life (HRQOL), treatment satisfaction (TS) medical resource use, and indirect costs in the SWITCH study. SWITCH was a multicentre, randomized, crossover study. Patients with type 1 diabetes (n = 153) using continuous subcutaneous insulin infusion (CSII) were randomized to a 12 month sensor-On/Off or sensor-Off/On sequence (6 months each treatment), with a 4-month washout between periods. HRQOL in children and TS in adults were measured using validated questionnaires. Medical resource utilization data were collected. In adults, TS was significantly higher in the sensor-On arm, and there were significant improvements in ratings for treatment convenience and flexibility. There were no clinically significant differences in children’s HRQOL or parents’ proxy ratings. The incidence of severe hypoglycaemia, unscheduled visits, or diabetes-related hospitalizations did not differ significantly between the two arms. Adult patients made fewer telephone consultations during the sensor-On arm; children’s caregivers made similar numbers of telephone consultations during both arms, and calls were on average only 3 min longer during the sensor-On arm. Regarding indirect costs, children with [70 % sensor usage missed fewer school days, compared with the sensor-Off arm (P = 0.0046) but there was no significant difference in the adults days of work off. The addition of CGM to CSII resulted in better metabolic control without imposing an additional burden on the patient or increased medical resource use, and offered the potential for cost offsets. [less ▲]

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See detailUse of vitamin D supplements during infancy in an international feeding trial
Lehtonen, E.; Ormisson, A.; Nucci, A. et al

in Public Health Nutrition (2014), 17(4), 810-822

To examine the use of vitamin D supplements during infancy among the participants in an international infant feeding trial. Longitudinal study.

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See detailRecruitment and retention of participants for an international type 1 diabetes prevention trial: a coordinators' perspective.
Franciscus, Margaret; Nucci, Anita; Bradley, Brenda et al

in Clinical Trials: Journal of the Society for Clinical Trials (2014), 11(2), 150-8

BACKGROUND: The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A ... [more ▼]

BACKGROUND: The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A unique feature of TRIGR has been recruitment of eligible pregnant women and enrollment of newborns for long-term follow-up assessments. PURPOSE: Our purpose is to summarize the recruitment and retention strategies used to conduct TRIGR from the perspective of the study coordinators. METHODS: TRIGR was designed to test whether weaning to formula containing hydrolyzed versus intact cow's milk protein would be efficacious in decreasing risk for development of T1D-associated autoantibodies and T1D among infants identified to be at increased risk for T1D based on their human leukocyte antigen (HLA) profile and family history. Multiple strategies tailored to local issues were required to enroll and follow the target number of infants. RESULTS: This study was conducted in the United States, Canada, Australia, and 12 countries in Europe. Of the 5606 mothers registered worldwide, 5000 of their infants were randomized. Of these, 2159 were HLA eligible and enrolled in the 8-month intervention and 10-year follow-up phases of this study. The TRIGR study met the accrual goal after 4.7 years of recruitment, 2.7 years longer than projected initially. Challenges included difficulty in finding fathers with T1D, a higher than expected rate of premature delivery among T1D mothers, and implementation of new privacy regulations mid-trial. The majority of participants were recruited from primary care antenatal clinics located near the study centers and from a general hospital or pediatric center that was affiliated with a TRIGR Study center. Internet and magazine advertisements were found to be useful for recruitment of families. Alternative follow-up strategies are offered to families who wish to reduce or discontinue participation. LIMITATIONS: Our experience is limited to a single international multicenter trial. CONCLUSIONS: TRIGR coordinators played key roles in the recruitment and intervention periods and continue to be instrumental in retaining families and children during the 10-year follow-up period for each child. [less ▲]

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See detailJoining forces: a call for greater collaboration to study new medicines in children and adolescents with type 2 diabetes.
Karres, Janina; Pratt, Valerie; Guettier, Jean-Marc et al

in Diabetes Care (2014), 37(10), 2665-2667

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See detailA novel GATA6 mutation in a child with congenital heart malformation and neonatal diabetes.
Eifes, Serge UL; Chudasama, Kishan K.; Molnes, Janne et al

in Clinical Case Reports (2013), 1(2), 86-90

Diabetes in neonates is a monogenetic disease and genetic analysis is warranted to allow best treatment, prognosis, and genetic counseling. Transcription factor mutations may have a variable expression ... [more ▼]

Diabetes in neonates is a monogenetic disease and genetic analysis is warranted to allow best treatment, prognosis, and genetic counseling. Transcription factor mutations may have a variable expression and different organs may be involved. [less ▲]

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See detailDo eating behaviors in the general population account for country variance in glycemic control among adolescents with diabetes: the Hvidoere Study Group and the Health Behaviour in School-Aged Children study.
Due, Pernille; De Beaufort, Carine UL; Damsgaard, Mogens Trab et al

in Pediatric diabetes (2013), 14(8), 554-561

BACKGROUND: The Hvidoere Study Group (HSG) has demonstrated major differences in glycemic control between pediatric diabetes centers which remain largely unexplained. This study investigates whether these ... [more ▼]

BACKGROUND: The Hvidoere Study Group (HSG) has demonstrated major differences in glycemic control between pediatric diabetes centers which remain largely unexplained. This study investigates whether these differences are partly attributable to healthy eating norms in the background population. METHODS: The study involved adolescents from 18 countries from (i) the Health Behaviour in School-Aged Children study (HBSC) and (ii) the HSG. There were 94 387 participants from representative HBSC samples of 11-, 13- and 15-yr-olds and 1483 11- to 15-yr-old adolescents with diabetes from the HSG. The frequency of intake of fruit, vegetables, sweets, sugary soft drinks, and daily breakfast was compared between the two groups. The glycemic control of the adolescents in the HSG cohort was determined by measuring glycated hemoglobin (HbA1c). RESULTS: Across countries in the HSBC survey, there was substantial variation in prevalence of healthy eating behavior and even greater variation between adolescents from the HSG centers. In all countries more adolescents with diabetes reported healthy eating behavior compared to national norms. In individuals healthy eating behavior had a significant effect on the individual level HbA1c. There was no significant correlation between the frequencies of these healthy eating behaviors at (i) the national level and (ii) diabetes center level and the center mean HbA1c. CONCLUSIONS: Although individual healthy eating behavior is associated with better glycemic control at the individual level, such eating behavior does not explain the center differences in HbA1c. Similarly, the reported healthy eating norm of the background populations does not explain the variation in glycemic control among centers. [less ▲]

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See detailMicrobiome and type 1 diabetes
Wampach, Linda UL; Wilmes, Paul UL; De Beaufort, Carine UL

E-print/Working paper (2013)

The human microbiome (the collective of microorganisms, which inhabit the human body) and changes therein (often referred to as microbial dysbiosis) is emerging as a potential player in the development of ... [more ▼]

The human microbiome (the collective of microorganisms, which inhabit the human body) and changes therein (often referred to as microbial dysbiosis) is emerging as a potential player in the development of type 1 diabetes mellitus. This section discusses the human microbiome and its potential involvement in type 1 diabetes through its central roles in energy metabolism and modulation of the immune system. [less ▲]

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See detailLessons from the Hvidoere International Study Group on childhood diabetes: Be dogmatic about outcome and flexible in approach
Cameron, F. J.; De Beaufort, Carine UL; Aanstoot, H.-J. et al

in Pediatric Diabetes (2013), 14(7), 473-480

[No abstract available]

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See detailDoes biological maturity actually confound gender-related differences in physical activity in preadolescence?
Guinhouya, B.C.; Fairclough, S.J.; Zitouni, D. et al

in Child: Care, Health and Development (2013), 39(6), 835-844

Aim To examine: (i) if maturity-related gender differences in moderate-to-vigorous physical activity (MVPA) depend on how maturity status is defined and measured; and (ii) the influence of maturity level ... [more ▼]

Aim To examine: (i) if maturity-related gender differences in moderate-to-vigorous physical activity (MVPA) depend on how maturity status is defined and measured; and (ii) the influence of maturity level on compliance with PA recommendations. Methods The study involved 253 children (139 boys) aged 9.9 ± 0.9 years, with mean stature and weight of 1.39 ± 0.08 m and 35.8 ± 8.8 kg respectively. Their PA was evaluated using an Actigraph accelerometer (Model 7164). Maturity was assessed using the estimated age at peak height velocity (APHV) and a standardized APHV by gender (i.e. centred APHV). Results Boys engaged in significantly more MVPA than girls (P < 0.0001). There was a significant correlation between the centred APHV and MVPA in boys (r = 0.20; P = 0.016), but not in girls (r = 0.13; P = 0.155). An ancova controlling for the estimated APHV showed no significant interactions between gender and APHV, and the main effect of gender on MVPA was negated. Conversely, there was a significant main effect of APHV on MVPA (F 1,249 = 6.12; P = 0.014; η p 2 = 0.024). Only 9.1% of children met the PA recommendations, including 14.4% of boys and 2.6% of girls (P < 0.01). This observation also applies in both pre-APHV (12.7% of boys vs. 2.4% of girls, P < 0.001) and post-APHV children (23.8% of boys vs. 3.4% of girls, P < 0.0001). No differences in PA guidelines were observed between pre-APHV and post-APHV children. Conclusions Among prepubescent children, the influence of biological maturity on gender differences in PA may be a function of how maturity status is determined. The most physically active prepubescent children were those who were on time according to APHV. [less ▲]

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See detailDoes the body adiposity index (BAI) apply to paediatric populations?
El Aarbaoui, T.; Samouda, H.; Zitouni, D. et al

in Annals of Human Biology (2013), 40(5), 451-458

Objective: Validation of body adiposity index (BAI) in a paediatrics sample; and to develop, if necessary, a valid BAI for paediatrics (i.e. BAIp). Methods: A total of 1615 children (52% boys) aged 5-12 ... [more ▼]

Objective: Validation of body adiposity index (BAI) in a paediatrics sample; and to develop, if necessary, a valid BAI for paediatrics (i.e. BAIp). Methods: A total of 1615 children (52% boys) aged 5-12 years underwent anthropometry. Their body composition was assessed using a foot-to-foot bioimpedance. The validity of BAI=(Hip circumference/Height1.5)-18 was tested by combining correlation and agreement statistics. Then, the sample was split into two sub-samples for the construction of BAIp. A regression was used to compute the prediction equation for BAIp-based percentage of body fat (%BF). Results: The initial BAI over-estimated the %BF of children by 49% (29.6±4.2% versus 19.8±6.8%; p<0.0001). The original methodology led to a BAIp=(Hip circumference/Height0.8) - 38 in children. When compared to BAI, BAIp showed both better correlation (r=0.57; p<0.01 versus r=0.74; p<0.0001) and agreement (ICC=0.34; [95% CI=-0.19-0.65] versus ICC=0.83; [95% CI=0.81-0.84]). However, there were some systematic biases between the two values of %BF as exemplified by the large 95% limit of agreement [-9.1%; 8.8%] obtained. Conclusion: BAI over-estimates the %BF in children. In contrast, BAIp appears as a new index for children's body fatness, with acceptable accuracy. In its current form, this index is valid only for large-scale studies. © 2013 Informa UK Ltd. All rights reserved: reproduction in whole or part not permitted. [less ▲]

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See detailLevel of physical activity among children and adolescents in Europe: A review of physical activity assessed objectively by accelerometry
Guinhouya, B. C.; Samouda, H.; De Beaufort, Carine UL

in Public Health (2013), 127(4), 301-311

This study explored the proportion of European youth who are sufficiently active according to physical activity (PA) recommendations, based exclusively on objective assessment through accelerometers. A ... [more ▼]

This study explored the proportion of European youth who are sufficiently active according to physical activity (PA) recommendations, based exclusively on objective assessment through accelerometers. A systematic electronic search of studies published up to March 2012 was conducted. PubMed was used to identify accelerometry-assessed PA studies that involved European youth. Within the 131 European studies, only 35 clearly reported the proportion of youth meeting the PA recommendations. Different thresholds lying between 1000 and 4000 counts/min (cpm) were used to define moderate-to-vigorous PA (MVPA). Overall, up to 100% of youth may be sufficiently active when using a threshold of approximately >1000-1500 cpm. With the most cited cut-off point (i.e. >2000 cpm), up to 87% of European youth might be considered physically active with reference to the current recommendations. Alternatively, with a cut-off point >3000 cpm, no more than 3-5% of them appeared to achieve these recommendations. The large discrepancy in outcomes released by accelerometer data is mainly due to the variety of cut-off points for MVPA among youth, hindering the definition of a clear goal towards PA promotion in Europe. Standardization of methods is urgently required. © 2013 The Royal Society for Public Health. [less ▲]

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See detailInvasive fungal infection and impaired neutrophil killing in human CARD9 deficiency.
Drewniak, Agata; Gazendam, Roel P.; Tool, Anton T. J. et al

in Blood (2013), 121(13), 2385-2392

Caspase recruitment domain-containing protein 9 (CARD9) is an adaptor molecule in the cytosol of myeloid cells, required for induction of T-helper cells producing interleukin-17 (Th17 cells) and important ... [more ▼]

Caspase recruitment domain-containing protein 9 (CARD9) is an adaptor molecule in the cytosol of myeloid cells, required for induction of T-helper cells producing interleukin-17 (Th17 cells) and important in antifungal immunity. In a patient suffering from Candida dubliniensis meningoencephalitis, mutations in the CARD9 gene were found to result in the loss of protein expression. Apart from the reduced numbers of CD4(+) Th17 lymphocytes, we identified a lack of monocyte-derived cytokines in response to Candida strains. Importantly, CARD9-deficient neutrophils showed a selective Candida albicans killing defect with abnormal ultrastructural phagolysosomes and outgrowth of hyphae. The neutrophil killing defect was independent of the generation of reactive oxygen species by the reduced NAD phosphate oxidase system. Taken together, this demonstrates that human CARD9 deficiency results in selective defect in the host defense against invasive fungal infection, caused by an impaired phagocyte killing. [less ▲]

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See detailCross-border flow of health information: is 'privacy by design' enough? Privacy performance assessment in EUBIROD
Di Iorio, C.T.; Carinci, F.; Brillante, M. et al

in European Journal of Public Health (2013), 23(2), 247-253

Background: The EUBIROD project aims to perform a cross-border flow of diabetes information across 19 European countries using the BIRO information system, which embeds privacy principles and data ... [more ▼]

Background: The EUBIROD project aims to perform a cross-border flow of diabetes information across 19 European countries using the BIRO information system, which embeds privacy principles and data protection mechanisms in its architecture (privacy by design). A specific task of EUBIROD was to investigate the variability in the implementation of the EU Data Protection Directive (DPD) across participating centres. Methods: Compliance with privacy requirements was assessed by means of a specific questionnaire administered to all participating diabetes registers. Items included relevant issues e.g. patient consent, accountability of data custodian, communication (openness) and complaint procedures (challenging compliance), authority to disclose, accuracy, access and use of personal information, and anonymization. The identification of an ad hoc scoring system and statistical software allowed an overall quali-quantitative analysis and independent evaluation of questionnaire responses, automated through a dedicated IT platform (‘privacy performance assessment’). Results: A total of 18 diabetes registers from different countries completed the survey. Over 50% of the registers recorded a maximum score for accountability, openness, anonymization and challenging compliance. Low average values were found for disclosure and disposition, access, consent, use of personal information and accuracy. A high heterogeneity was found for anonymization, consent, accuracy and access. Conclusions: The novel method of privacy performance assessment realized in EUBIROD may improve the respect of privacy in each data source, reduce overall variability in the implementation of privacy principles and favour a sound and legitimate cross-border exchange of high quality data across Europe. [less ▲]

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See detailThe use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial
Battelino, T.; Conget, I.; Olsen, B. et al

in Diabetologia (2012), 55(12), 3155-3162

Aims/hypothesis The aim of this multicentre, randomised, controlled crossover study was to determine the efficacy of adding continuous glucose monitoring (CGM) to insulin pump therapy (CSII) in type 1 ... [more ▼]

Aims/hypothesis The aim of this multicentre, randomised, controlled crossover study was to determine the efficacy of adding continuous glucose monitoring (CGM) to insulin pump therapy (CSII) in type 1 diabetes. Methods Children and adults (n = 153) on CSII with HbA1c 7.5–9.5% (58.5–80.3 mmol/mol) were randomised to (CGM) a Sensor On or Sensor Off arm for 6 months. After 4 months’ washout, participants crossed over to the other arm for 6 months. Paediatric and adult participants were separately electronically randomised through the case report form according to a predefined randomisation sequence in eight secondary and tertiary centres. The primary outcome was the difference in HbA1c levels between arms after 6 months. Results Seventy-seven participants were randomised to the On/Off sequence and 76 to the Off/On sequence; all were included in the primary analysis. The mean difference in HbA1c was –0.43% (–4.74 mmol/mol) in favour of the Sensor On arm (8.04% [64.34 mmol/mol] vs 8.47% [69.08 mmol/mol]; 95% CI −0.32%, −0.55% [−3.50, −6.01 mmol/mol]; p < 0.001). Following cessation of glucose sensing, HbA1c reverted to baseline levels. Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day; p = 0.009). The mean number of daily boluses increased in the Sensor On arm (6.8 ± 2.5 vs 5.8 ± 1.9, p < 0.0001), together with the frequency of use of the temporary basal rate (0.75 ± 1.11 vs 0.26 ± 0.47, p < 0.0001) and manual insulin suspend (0.91 ± 1.25 vs 0.70 ± 0.75, p < 0.018) functions. Four vs two events of severe hypoglycaemia occurred in the Sensor On and Sensor Off arm, respectively (p = 0.40). Conclusions/interpretation Continuous glucose monitoring was associated with decreased HbA1c levels and time spent in hypoglycaemia in individuals with type 1 diabetes using CSII. More frequent self-adjustments of insulin therapy may have contributed to these effects. [less ▲]

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See detailBreast-feeding and childhood-onset type 1 diabetes: a pooled analysis of individual participant data from 43 observational studies
Cardwell, C.R.; Stene, L.C.; Ludvigsson, J. et al

in Diabetes Care (2012), 35(11), 2215-2225

OBJECTIVE To investigate if there is a reduced risk of type 1 diabetes in children breastfed or exclusively breastfed by performing a pooled analysis with adjustment for recognized confounders. RESEARCH ... [more ▼]

OBJECTIVE To investigate if there is a reduced risk of type 1 diabetes in children breastfed or exclusively breastfed by performing a pooled analysis with adjustment for recognized confounders. RESEARCH DESIGN AND METHODS Relevant studies were identified from literature searches using MEDLINE, Web of Science, and EMBASE. Authors of relevant studies were asked to provide individual participant data or conduct prespecified analyses. Meta-analysis techniques were used to combine odds ratios (ORs) and investigate heterogeneity between studies. RESULTS Data were available from 43 studies including 9,874 patients with type 1 diabetes. Overall, there was a reduction in the risk of diabetes after exclusive breast-feeding for >2 weeks (20 studies; OR = 0.75, 95% CI 0.64–0.88), the association after exclusive breast-feeding for >3 months was weaker (30 studies; OR = 0.87, 95% CI 0.75–1.00), and no association was observed after (nonexclusive) breast-feeding for >2 weeks (28 studies; OR = 0.93, 95% CI 0.81–1.07) or >3 months (29 studies; OR = 0.88, 95% CI 0.78–1.00). These associations were all subject to marked heterogeneity (I2 = 58, 76, 54, and 68%, respectively). In studies with lower risk of bias, the reduced risk after exclusive breast-feeding for >2 weeks remained (12 studies; OR = 0.86, 95% CI 0.75–0.99), and heterogeneity was reduced (I2 = 0%). Adjustments for potential confounders altered these estimates very little. CONCLUSIONS The pooled analysis suggests weak protective associations between exclusive breast-feeding and type 1 diabetes risk. However, these findings are difficult to interpret because of the marked variation in effect and possible biases (particularly recall bias) inherent in the included studies. [less ▲]

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See detailRecommendations for age-appropriate education of children and adolescents with diabetes and their parents in the European Union
Martin, D.; Lange, K.; Sima, A. et al

in Pediatric Diabetes (2012), 13(16), 20-28

Education is the keystone of diabetes care, and structured self-management education is the key to a successful outcome. Existing guidelines provide comprehensive guidance on the various aspects of ... [more ▼]

Education is the keystone of diabetes care, and structured self-management education is the key to a successful outcome. Existing guidelines provide comprehensive guidance on the various aspects of education and offer general and organizational principles of education, detailed curricula at different ages and stages of diabetes, and recommendations on models, methods, and tools to attain educative objectives. The International Society for Pediatric and Adolescent Diabetes guidelines give the most elaborate and detailed descriptions and recommendations on the practice of education, which other national guidelines address on specific aspects of education and care. The aim of the work package on education developed by Better Control in Paediatric and Adolescent Diabetes in the European Union: Working to Create Centers of Reference ( SWEET) project was not to generate new guidelines but to evaluate how the existing guidelines were implemented in some pediatric diabetes reference centers. The SWEET members have completed a questionnaire that elaborates on the many aspects of delivery of education. This survey highlights a profound diversity of practices across centers in Europe, in terms of organization as well as the practices and the content of initial and continuing education. A toolbox is being developed within SWEET to facilitate exchanges on all aspects of education and to establish a process of validation of materials, tools, written structured age-adjusted programs, and evaluation procedures for the education of children and adolescents with diabetes. [less ▲]

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See detailCriteria for Centers of Reference for pediatric diabetes--a European perspective
Danne, T.; Lion, S.; Madaczy, L. et al

in Pediatric Diabetes (2012), 13(16), 62-75

' SWEET' is an acronym standing for 'Better control in pediatric and adolescent diabeteS: Working to crEate CEnTers of Reference ( CORs)' and is based on a partnership of established national and European ... [more ▼]

' SWEET' is an acronym standing for 'Better control in pediatric and adolescent diabeteS: Working to crEate CEnTers of Reference ( CORs)' and is based on a partnership of established national and European diabetes organizations such as International Diabetes Federation, Federation of European Nurses in Diabetes, and Primary Care Diabetes Europe (PCDE, www.sweet-project.eu). A three-level classification of centers has been put forward. In addition to centers for local care, SWEET collaborating centers on their way to being a COR have been defined. Peer-audited CORs with a continuous electronic documentation of at least 150 pediatric patients with diabetes treated by a multidisciplinary team based on the International Society for Pediatric and Adolescent Diabetes ( ISPAD) Clinical Practice recommendations have been created in 12 European countries. In 2011, they cared for between 150 to more than 700 youth with diabetes with an average hemoglobin A1c between 7.6 and 9.2%. Although these clinics should not be regarded as representative for the whole country, the acknowledgment as COR includes a common objective of targets and guidelines as well as recognition of expertise in treatment and education at the center. In a first step, the SWEET Online platform allows 12 countries using 11 languages to connect to one unified diabetes database. Aggregate data are de-identified and exported for longitudinal health and economic data analysis. Through their network, the CORs wish to obtain political influence on a national and international level and to facilitate dissemination of new approaches and techniques. The SWEET project hopes to extend from the initial group of centers within countries, throughout Europe, and beyond with the help of the ISPAD network. [less ▲]

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See detailTechnical solution for data collection, data safety and data privacy legislation: experiences from the SWEET study.
Forsander, Gun; Pellinat, Martin; Volk, Michael et al

in Pediatric diabetes (2012), 13(16), 39-48

BACKGROUND: One of the most important tasks of the SWEET study is benchmarking the data collected. Information on the occurrence of the disease of diabetes, the treatment, and their outcomes in children ... [more ▼]

BACKGROUND: One of the most important tasks of the SWEET study is benchmarking the data collected. Information on the occurrence of the disease of diabetes, the treatment, and their outcomes in children from the different member states of European Union (EU) is crucial. How the collection of data is realized is essential, concerning both the technical issues and the results. The creation of SWEET Centers of Reference (CoR), all over Europe will be facilitated by the access to safe data collection, where legal aspects and privacy are ascertained. OBJECTIVE: To describe the rationale for- and the technical procedure in the data collection implementation, in the SWEET study. SUBJECTS: Selected data on all patients treated at SWEET CoR are collected. METHODS: The SWEET project data collection and management system, consists of modular components for data collection, online data interchange, and a database for statistical analysis. CONCLUSION: The SWEET study and the organization of CoR aims for the goal of offering an updated, secure, and continuous evaluation of diabetes treatment regimens for all children with diabetes in Europe. To support this goal, an appropriate and secure data management system as described in this paper has been created. [less ▲]

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See detailMetabolic outcomes in young children with type 1 diabetes differ between treatment centers: the Hvidoere Study in Young Children 2009
De Beaufort, Carine UL; Lange, K.; Swift, P.G. et al

in Pediatric Diabetes (2012), 14(6), 422-428

Objective: To investigate whether center differences in glycemic control are present in prepubertal children <11 yr with type 1 diabetes mellitus. Research Design and Methods: This cross-sectional study ... [more ▼]

Objective: To investigate whether center differences in glycemic control are present in prepubertal children <11 yr with type 1 diabetes mellitus. Research Design and Methods: This cross-sectional study involved 18 pediatric centers worldwide. All children, <11 y with a diabetes duration ≥12 months were invited to participate. Case Record Forms included information on clinical characteristics, insulin regimens, diabetic ketoacidosis (DKA), severe hypoglycemia, language difficulties, and comorbidities. Hemoglobin A1c (HbA1c) was measured centrally by liquid chromatography (DCCT aligned, range: 4.4-6.3%; IFFC: 25-45 mmol/mol). Results: A total of 1133 children participated (mean age: 8.0 ± 2.1 y; females: 47.5%, mean diabetes duration: 3.8 ± 2.1 y). HbA1c (overall mean: 8.0 ± 1.0%; range: 7.3-8.9%) and severe hypoglycemia frequency (mean 21.7 events per 100 patient-years), but not DKA, differed significantly between centers (p < 0.001 resp. p = 0.179). Language difficulties showed a negative relationship with HbA1c (8.3 ± 1.2% vs. 8.0 ± 1.0%; p = 0.036). Frequency of blood glucose monitoring demonstrated a significant but weak association with HbA1c (r = -0.17; p < 0.0001). Although significant different HbA1c levels were obtained with diverse insulin regimens (range: 7.3-8.5%; p < 0.001), center differences remained after adjusting for insulin regimen (p < 0.001). Differences between insulin regimens were no longer significant after adjusting for center effect (p = 0.199). Conclusions: Center differences in metabolic outcomes are present in children <11 yr, irrespective of diabetes duration, age, or gender. The incidence of severe hypoglycemia is lower than in adolescents despite achieving better glycemic control. Insulin regimens show a significant relationship with HbA1c but do not explain center differences. Each center's effectiveness in using specific treatment strategies remains the key factor for outcome. [less ▲]

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