Assessment and monitoring of glycemic control in children and adolescents with diabetes

in Pediatric diabetes (2014), 15 Suppl 20

The article presents a chapter of the guidelines on pediatric diabetes in the International Society for Pediatric and Adolescent Diabetes (ISPAD) Clinical Practice Consensus Guidelines 2014 Compedium. It ... [more ▼]

The article presents a chapter of the guidelines on pediatric diabetes in the International Society for Pediatric and Adolescent Diabetes (ISPAD) Clinical Practice Consensus Guidelines 2014 Compedium. It explores the recommendations for screening and monitoring of glycemic control in diabetic children and adolescents. It compares the grading system used in the ISPAD guidelines with that of the American Diabetes Association. [less ▲]

Recruitment and retention of participants for an international type 1 diabetes prevention trial: a coordinators' perspective.

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 ▲]

Joining forces: a call for greater collaboration to study new medicines in children and adolescents with type 2 diabetes.

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

Do 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.

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 ▲]

Microbiome and type 1 diabetes

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 ▲]

Lessons from the Hvidoere International Study Group on childhood diabetes: Be dogmatic about outcome and flexible in approach

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

[No abstract available]

Does the body adiposity index (BAI) apply to paediatric populations?

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 ▲]

Invasive fungal infection and impaired neutrophil killing in human CARD9 deficiency.

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 ▲]

The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial

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 ▲]

Good practice recommendations on paediatric training programmes for health care professionals in the EU.

in Pediatric Diabetes (2012), 13(16), 29-38

Part of the SWEET Project: EU (European Union), Better Control in Paediatric and Adolescent Diabetes: Working to Create Centres of Reference, was specifically to examine the training of health care ... [more ▼]

Part of the SWEET Project: EU (European Union), Better Control in Paediatric and Adolescent Diabetes: Working to Create Centres of Reference, was specifically to examine the training of health care professionals (HCPs) across the EU. Several types of information were collected during 2009, and these included a literature search, workshops of the SWEET members, examination of the data collected by the Hvidøre Study Group and the Diabetes Attitudes, Wishes, and Needs (DAWN) Youth initiative, and a questionnaire distributed to SWEET members and professional colleagues who cared for children and young people (CYP) with diabetes. It was clear from the information collected that there was no European or global consensus either on a curriculum for the training of the paediatric diabetes multidisciplinary team (MDT) or individual professions in paediatric diabetes. A minority of countries had well-established training but, for the majority, there was little standardisation or accreditation. Moreover, most countries did not have available courses for training the diabetes MDT and training was not mandatory. Of the courses that were available more were accredited for doctors and nurses but fewer for the other professions. As a consequence, the majority of HCP posts in paediatric diabetes do not demand prior experience in the specialty. Standardised accredited training and continuous professional development (CPD) opportunities are severely limited. The SWEET Project supports a standardised, accredited approach to training and CPD of the MDT and for individual professions. As a consequence, a curriculum for the training of the MDT was developed, and this is now ready for implementation. [less ▲]