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1.  Lessons Learned From a Pilot RCT of Simultaneous Versus Delayed Initiation of Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy 
Uncertainty remains about effectiveness of continuous glucose monitoring (CGM) in pediatric type 1 diabetes (T1D). Success with CGM is related to CGM adherence, which may relate to readiness to make the behavior changes required for effective use. We hypothesize that readiness for change will be greater at initiation of insulin pump therapy than in established pump users, and that this will predict CGM adherence. Our objective was to evaluate the feasibility of a randomized controlled trial (RCT) in children with established T1D comparing simultaneous pump and CGM initiation to standard pump therapy with delayed CGM initiation. We randomized participants to simultaneous pump and CGM initiation or to standard pump therapy with the option of adding CGM 4 months later. CGM adherence was tracked via web-based download and readiness for change assessed with the SOCRATES questionnaire. Of 41 eligible children, 20 agreed to participate; 15 subjects completed the study (7 males; baseline age 11.8 ± 4.0 years; T1D duration 2.7 ± 2.7 years; mean A1C 8.2 ± 0.8%). Six of 8 simultaneous group subjects used CGM > 60% of the time for 4 months compared to 1 of 7 delayed group subjects (P = .02). Using SOCRATES, we could assign 87-100% of subjects to a single motivation stage at baseline and 4 months. This pilot study demonstrates the feasibility of randomizing pump naïve children and adolescents with established T1D to simultaneous pump and CGM initiation versus standard pump therapy with delayed CGM initiation. Lessons from this pilot study were used to inform development of a full-scale multicenter RCT.
PMCID: PMC4455437  PMID: 24876616
child; continuous glucose monitoring; diabetes mellitus; type 1; insulin pump; patient adherence
2.  Decision coaching using the Ottawa family decision guide with parents and their children: a field testing study 
Although children can benefit from being included in health decisions, little is known about effective interventions to support their involvement. The objective of this study was to evaluate the feasibility and acceptability of decision coaching guided by the Ottawa Family Decision Guide with children and parents considering insulin delivery options for type 1 diabetes (insulin pump, multiple daily injections, or standard insulin injections).
Pre-/post-test field testing design. Eligible participants were children (≤18 years) with type 1 diabetes and their parents attending an ambulatory diabetes clinic in a tertiary children’s hospital. Parent–child dyads received decision coaching using the Ottawa Family Decision Guide that was pre-populated with evidence on insulin delivery options, benefits, and harms. Primary outcomes were feasibility of recruitment and data collection, and parent and child acceptability of the intervention.
Of 16 families invited to participate, 12 agreed and 7 attended the decision coaching session. For the five missed families, two families were unable to attend the session or the decision coach was not available (N=3). Baseline and immediately post-coaching questionnaires were all completed and follow-up questionnaires two weeks post-coaching were missing from one parent–child dyad. Missing questionnaire items were 5 of 340 items for children (1.5%) and 1 of 429 for parents (0.2%). Decision coaching was rated as acceptable with higher scores from parents and their children who were in earlier stages of decision making.
Decision coaching with children and their parents considering insulin options was feasible implement and evaluate in our diabetes clinic and was acceptable to participants. Recruitment was difficult due to scheduling restrictions related to the timing of the study. Coaching should target participants earlier in the decision making process and be scheduled at times that are convenient for families and coaches. Findings were used to inform a full-scale evaluation that is currently underway.
PMCID: PMC4326318  PMID: 25889602
Children; Parents; Decision-coaching; Patient decision aid; Diabetes
3.  Use of vitamin D supplements during infancy in an international feeding trial 
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.
Information about vitamin D supplementation was collected through a validated FFQ at the age of 2 weeks and monthly between the ages of 1 month and 6 months.
Infants (n 2159) with a biological family member affected by type 1 diabetes and with increased human leucocyte antigen-conferred susceptibility to type 1 diabetes from twelve European countries, the USA, Canada and Australia.
Daily use of vitamin D supplements was common during the first 6 months of life in Northern and Central Europe (>80% of the infants), with somewhat lower rates observed in Southern Europe (>60 %). In Canada, vitamin D supplementation was more common among exclusively breast-fed than other infants (e.g. 71% v. 44% at 6 months of age). Less than 2% of infants in the USA and Australia received any vitamin D supplementation. Higher gestational age, older maternal age and longer maternal education were study-wide associated with greater use of vitamin D supplements.
Most of the infants received vitamin D supplements during the first 6 months of life in the European countries, whereas in Canada only half and in the USA and Australia very few were given supplementation.
PMCID: PMC4225543  PMID: 23795865
Vitamin D; Supplementation; Infancy
4.  Hydrolyzed Infant Formula and Early β-Cell Autoimmunity 
JAMA  2014;311(22):2279-2287.
The disease process leading to clinical type 1 diabetes often starts during the first years of life. Early exposure to complex dietary proteins may increase the risk of β-cell autoimmunity in children at genetic risk for type 1 diabetes. Extensively hydrolyzed formulas do not contain intact proteins.
To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of diabetes-associated autoantibodies in young children.
A double-blind randomized clinical trial of 2159 infants with HLA-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1078 were randomized to be weaned to the extensively hydrolyzed casein formula and 1081 were randomized to be weaned to a conventional cows’ milk–based formula. The participants were observed to April 16, 2013.
The participants received either a casein hydrolysate or a conventional cows’ milk formula supplemented with 20% of the casein hydrolysate.
Primary outcome was positivity for at least 2 diabetes-associated autoantibodies out of 4 analyzed. Autoantibodies to insulin, glutamic acid decarboxylase, and the insulinoma-associated–2 (IA-2) molecule were analyzed using radiobinding assays and islet cell antibodies with immunofluorescence during a median observation period of 7.0 years (mean, 6.3 years).
The absolute risk of positivity for 2 or more islet autoantibodies was 13.4% among those randomized to the casein hydrolysate formula (n = 139) vs 11.4% among those randomized to the conventional formula (n = 117). The unadjusted hazard ratio for positivity for 2 or more autoantibodies among those randomized to be weaned to the casein hydrolysate was 1.21 (95% CI, 0.94–1.54), compared with those randomized to the conventional formula, while the hazard ratio adjusted for HLA risk, duration of breastfeeding, vitamin D use, study formula duration and consumption, and region was 1.23 (95% CI, 0.96–1.58). There were no clinically significant differences in the rate of reported adverse events between the 2 groups.
Among infants at risk for type 1 diabetes, the use of a hydrolyzed formula, when compared with a conventional formula, did not reduce the incidence of diabetes-associated autoantibodies after 7 years. These findings do not support a benefit from hydrolyzed formula.
TRIAL REGISTRATION Identifier: NCT00179777
PMCID: PMC4225544  PMID: 24915259
5.  The JDRF CCTN CGM TIME Trial: Timing of Initiation of continuous glucose Monitoring in Established pediatric type 1 diabetes: study protocol, recruitment and baseline characteristics 
BMC Pediatrics  2014;14:183.
Continuous glucose monitoring (CGM) has been shown to improve glucose control in adults with type 1 diabetes. Effectiveness of CGM is directly linked with CGM adherence, which can be challenging to maintain in children and adolescents. We hypothesize that initiating CGM at the same time as starting insulin pump therapy in pump naïve children and adolescents with type 1 diabetes will result in greater CGM adherence and effectiveness compared to delaying CGM introduction by 6 months, and that this is related to greater readiness for making behaviour change at the time of pump initiation.
The CGM TIME Trial is a multicenter randomized controlled trial. Eligible children and adolescents (5-18 years) with established type 1 diabetes were randomized to simultaneous initiation of pump (Medtronic Veo©) and CGM (Enlite©) or to standard pump therapy with delayed CGM introduction. Primary outcomes are CGM adherence and hemoglobin A1C at 6 and 12 months post pump initiation. Secondary outcomes include glycemic variability, stage of readiness, and other patient-reported outcomes with follow-up to 24 months. 144 (95%) of the 152 eligible patients were enrolled and randomized. Allowing for 10% withdrawals, this will provide 93% power to detect a between group difference in CGM adherence and 86% power to detect a between group difference in hemoglobin A1C. Baseline characteristics were similar between the treatment groups. Analysis of 12 month primary outcomes will begin in September 2014.
The CGM TIME Trial is the first study to examine the relationship between timing of CGM initiation, readiness for behaviour change, and subsequent CGM adherence in pump naïve children and adolescents. Its findings will advance our understanding of when and how to initiate CGM in children and adolescents with type 1 diabetes.
Trial registration NCT01295788. Registered 14 February 2011.
PMCID: PMC4109785  PMID: 25034216
Continuous glucose monitoring; Continuous subcutaneous insulin infusion; Type 1 diabetes; Adherence; Pediatrics; Glycosylated hemoglobin; Children; Adolescents; Quality of life; Treatment satisfaction
6.  Interventions to support children’s engagement in health-related decisions: a systematic review 
BMC Pediatrics  2014;14:109.
Children often need support in health decision-making. The objective of this study was to review characteristics and effectiveness of interventions that support health decision-making of children.
A systematic review. Electronic databases (PubMed, the Cochrane Library, Web of Science, Scopus, ProQuest Dissertations and Theses, CINAHL, PsycINFO, MEDLINE, and EMBASE) were searched from inception until March 2012. Two independent reviewers screened eligibility: a) intervention studies; b) involved supporting children (≤18 years) considering health-related decision(s); and c) measured decision quality or decision-making process outcomes. Data extraction and quality appraisal were conducted by one author and verified by another using a standardized data extraction form. Quality appraisal was based on the Cochrane Risk of Bias tool.
Of 4313 citations, 5 studies were eligible. Interventions focused on supporting decisions about risk behaviors (n = 3), psycho-educational services (n = 1), and end of life (n = 1). Two of 5 studies had statistically significant findings: i) compared to attention placebo, decision coaching alone increased values congruence between child and parent, and child satisfaction with decision-making process (lower risk of bias); ii) compared to no intervention, a workshop with weekly assignments increased overall decision-making quality (higher risk of bias).
Few studies have focused on interventions to support children’s participation in decisions about their health. More research is needed to determine effective methods for supporting children’s health decision-making.
PMCID: PMC3999734  PMID: 24758566
Child; Adolescent; Decision making; Patient participation; Practice
7.  Presenting quantitative information about decision outcomes: a risk communication primer for patient decision aid developers 
Making evidence-based decisions often requires comparison of two or more options. Research-based evidence may exist which quantifies how likely the outcomes are for each option. Understanding these numeric estimates improves patients’ risk perception and leads to better informed decision making. This paper summarises current “best practices” in communication of evidence-based numeric outcomes for developers of patient decision aids (PtDAs) and other health communication tools.
An expert consensus group of fourteen researchers from North America, Europe, and Australasia identified eleven main issues in risk communication. Two experts for each issue wrote a “state of the art” summary of best evidence, drawing on the PtDA, health, psychological, and broader scientific literature. In addition, commonly used terms were defined and a set of guiding principles and key messages derived from the results.
The eleven key components of risk communication were: 1) Presenting the chance an event will occur; 2) Presenting changes in numeric outcomes; 3) Outcome estimates for test and screening decisions; 4) Numeric estimates in context and with evaluative labels; 5) Conveying uncertainty; 6) Visual formats; 7) Tailoring estimates; 8) Formats for understanding outcomes over time; 9) Narrative methods for conveying the chance of an event; 10) Important skills for understanding numerical estimates; and 11) Interactive web-based formats. Guiding principles from the evidence summaries advise that risk communication formats should reflect the task required of the user, should always define a relevant reference class (i.e., denominator) over time, should aim to use a consistent format throughout documents, should avoid “1 in x” formats and variable denominators, consider the magnitude of numbers used and the possibility of format bias, and should take into account the numeracy and graph literacy of the audience.
A substantial and rapidly expanding evidence base exists for risk communication. Developers of tools to facilitate evidence-based decision making should apply these principles to improve the quality of risk communication in practice.
PMCID: PMC4045391  PMID: 24625237
8.  Osteosclerosis in two brothers with autosomal dominant pseudohypoparathyroidism type 1b: bone histomorphometric analysis 
Pseudohypoparathyroidism (PHP) is a heterogeneous disorder characterized by hypocalcemia and hyperphosphatemia resulting from selective renal resistance to parathyroid hormone (PTH). One autosomal dominant form of PHP type 1b (PHP-Ib) is most frequently caused by a maternally inherited 3-kb deletion within STX16, the gene encoding syntaxin 16. To date, increased bone mineral density (BMD) has been described only in PHP type 1a, and there is a lack of detailed information on bone histomorphometry in PHP-Ib. The objective of this report was to present trans-iliac static and dynamic histomorphometry in two brothers with the 3-kb deletion in the STX16 region and elevated BMD.
Observational study of two brothers (age 18.0 and 22.7 years) with the 3-kb STX16 deletion and increased BMD.
The brothers had elevated PTH (146 pg/ml (15.6 pmol/l) and 102 pg/ml (10.9 pmol/l); normal: 10–64 pg/ml (1.1–6.8 pmol/l)) and striking osteosclerosis (lumbar spine areal BMD Z-scores: +5.4 and +4.9). Bone histomorphometry showed marked elevations in cortical width for both brothers (241 and 209% of the mean result expected for age), with elevations in the bone formation rate on the endocortical (119 and 260% of the healthy mean) and trabecular (220 and 190% of mean) surfaces.
Our findings suggest that PTH in this PHP-Ib genotype can increase cortical thickness due to its anabolic effect on endocortical bone, and underscore the heterogeneity in the skeletal phenotype among patients with PHP-Ib.
PMCID: PMC3810006  PMID: 21062889
9.  Multicentre randomized controlled trial of structured transition on diabetes care management compared to standard diabetes care in adolescents and young adults with type 1 diabetes (Transition Trial) 
BMC Pediatrics  2013;13:163.
Transition from pediatric to adult diabetes care is a high risk period during which there is an increased rate of disengagement from care. Suboptimal transition has been associated with higher risks for acute and chronic diabetes-related complications. The period of emerging adulthood challenges current systems of healthcare delivery as many young adults with type 1 diabetes (T1D) default from diabetes care and are at risk for diabetes complications which are undetected and therefore untreated. Despite the importance of minimizing loss to follow-up there are no randomized control trials evaluating models of transition from pediatric to adult diabetes care.
This is a multicentre randomized controlled trial. A minimum of 188 subjects with T1D aged between 17 and 20 years will be evaluated. Eligible subjects will be recruited from three pediatric care centres and randomly assigned in a 1:1 ratio to a structured transition program that will span 18 months or to receive standard diabetes care. The structured transition program is a multidisciplinary, complex intervention aiming to provide additional support in the transition period. A Transition Coordinator will provide transition support and will provide the link between pediatric and adult diabetes care. The Transition Coordinator is central to the intervention to facilitate ongoing contact with the medical system as well as education and clinical support where appropriate. Subjects will be seen in the pediatric care setting for 6 months and will then be transferred to the adult care setting where they will be seen for one year. There will then be a one-year follow-up period for outcome assessment. The primary outcome is the proportion of subjects who fail to attend at least one outpatient adult diabetes specialist visit during the second year after transition to adult diabetes care. Secondary outcome measures include A1C frequency measurement and levels, diabetes related emergency room visits and hospital admissions, frequency of complication screening, and subject perception and satisfaction with care.
This trial will determine if the support of a Transition Coordinator improves health outcomes for this at-risk population of young adults.
Trial registration
Trial Registration Number: NCT01351857
PMCID: PMC3879408  PMID: 24106787
Transition care; Adolescents and young adults; Transition intervention; Chronic illness; Type 1 diabetes; Healthcare systems
10.  Follow-Up Analysis of Genome-Wide Association Data Identifies Novel Loci for Type 1 Diabetes 
Diabetes  2009;58(1):290-295.
OBJECTIVE—Two recent genome-wide association (GWA) studies have revealed novel loci for type 1 diabetes, a common multifactorial disease with a strong genetic component. To fully utilize the GWA data that we had obtained by genotyping 563 type 1 diabetes probands and 1,146 control subjects, as well as 483 case subject–parent trios, using the Illumina HumanHap550 BeadChip, we designed a full stage 2 study to capture other possible association signals.
RESEARCH DESIGN AND METHODS—From our existing datasets, we selected 982 markers with P < 0.05 in both GWA cohorts. Genotyping these in an independent set of 636 nuclear families with 974 affected offspring revealed 75 markers that also had P < 0.05 in this third cohort. Among these, six single nucleotide polymorphisms in five novel loci also had P < 0.05 in the Wellcome Trust Case-Control Consortium dataset and were further tested in 1,303 type 1 diabetes probands from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) plus 1,673 control subjects.
RESULTS—Two markers (rs9976767 and rs3757247) remained significant after adjusting for the number of tests in this last cohort; they reside in UBASH3A (OR 1.16; combined P = 2.33 × 10−8) and BACH2 (1.13; combined P = 1.25 × 10−6).
CONCLUSIONS—Evaluation of a large number of statistical GWA candidates in several independent cohorts has revealed additional loci that are associated with type 1 diabetes. The two genes at these respective loci, UBASH3A and BACH2, are both biologically relevant to autoimmunity.
PMCID: PMC2606889  PMID: 18840781
11.  Disordered eating attitudes and behaviours in teenaged girls: a school-based study 
Disordered eating attitudes and behaviours are common in older teens and young women in Western countries. Recent evidence suggests that the prevalence of these disorders is rising and that the age of onset has fallen. In the present study, disturbed eating attitudes and behaviours were evaluated in a large school-based population in Ontario in order to determine their prevalence and demographic distribution.
Females, aged 12–18 years, from schools in Toronto, Hamilton and Ottawa were invited to complete questionnaires, including 3 subscales of the Eating Disorder Inventory (Drive for Thinness, Body Dissatisfaction, Bulimia), the Eating Attitudes Test-26 (EAT-26) and the Diagnostic Survey for Eating Disorders (DSED).
Questionnaires were completed by 1739 (70%) of the 2483 adolescent females who were approached. The mean age of subjects in the sample was 14.6 (standard deviation 1.9) years. Thirteen percent of those aged 12–14 years and 16% of those aged 15–18 years had scores above the recommended cut-off (≥ 20) for disordered eating on the EAT-26. Current dieting to lose weight was reported by 23% of participants. Binge eating with associated loss of control was reported by 15% of participants, self-induced vomiting by 8.2% and the use of diet pills by 2.4%. Laxative and diuretic misuse were uncommon. Dieting was associated with an increased risk of binge-eating and purging behaviours. Older age and body mass index in the highest quartile were independently related to symptoms of eating disorders.
Disordered eating attitudes and behaviours were present in over 27% of girls aged 12–18 years and were seen to increase gradually throughout adolescence. Prevention programs to diminish the progression and impact of these disorders should be implemented and assessed.
PMCID: PMC81412  PMID: 11563206
12.  Eating disorders in adolescent females with and without type 1 diabetes: cross sectional study 
BMJ : British Medical Journal  2000;320(7249):1563-1566.
To determine the prevalence of eating disorders in adolescent females with type 1 diabetes mellitus compared with that in their non-diabetic peers.
Cross sectional case-control led study.
Diabetes clinics and schools in three Canadian cities.
356 females aged 12-19 with type 1 diabetes and 1098 age matched non-diabetic controls.
Main outcome measure
Eating disorders meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria.
Eating disorders that met DSM-IV criteria were more prevalent in diabetic subjects (36, 10%) than in non-diabetic controls (49, 4%) (odds ratio 2.4, 95% confidence interval 1.5 to 3.7; P<0.001). Subthreshold eating disorders were also more common in those with diabetes (49, 14%) than in controls (84, 8%) (odds ratio 1.9, 95% confidence interval 1.3 to 2.8; P<0.001). Mean haemoglobin A1c concentration was higher in diabetic subjects with an eating disorder (9.4% (1.8)) than in those without (8.6% (1.6)), P=0.04).
DSM-IV and subthreshold eating disorders are almost twice as common in adolescent females with type 1 diabetes as in their non-diabetic peers. In diabetic subjects, eating disorders are associated with insulin omission for weight loss and impaired metabolic control.
PMCID: PMC27398  PMID: 10845962

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