Association of Fructosamine Levels With Glycemic Control in Children With Type 1 Diabetes as Determined by Continuous Glucose Monitoring: Results From the CGM TIME Trial.

OBJECTIVE: Our aim in this study was to determine the correlation between serum fructosamine and average blood glucose, as measured by continuous glucose monitoring (CGM) in children with type 1 diabetes. METHODS: Ninety-seven blood samples were collected from 70 participants in the Timing of Initiation of continuous glucose Monitoring in Established pediatric diabetes (CGM TIME) Trial. Each eligible participant had 3 weeks of CGM data with at least 60% CGM adherence before blood collection. Ordinary least-squares linear regression incorporating restricted cubic splines was used to determine the association between fructosamine levels and mean blood glucose. RESULTS: An association was found between fructosamine and mean blood glucose, with an F statistic of 9.543 (p<0.001). Data were used to create a formula and conversion chart for calculating mean blood glucose from fructosamine levels for clinical use. CONCLUSIONS: There is a complex relationship between average blood glucose, as determined by CGM and fructosamine. Fructosamine levels may be clinically useful for assessing short-term glycemic control when CGM is not available.

Pathways to Care for Adolescents Attending a First Hormone Appointment at Canadian Gender Affirming Medical Clinics: A Cross-Sectional Analysis From the Trans Youth CAN! Study.

PURPOSE: Limited research has examined adolescents' pathways to gender-affirming medical care. METHODS: Enrollment in Trans Youth CAN! was at an initial appointment for hormone suppression or gender-affirming hormones, if pubertal or postpubertal, and < 16 years old. Adolescent/parent surveys and clinical records were obtained for 174 adolescents and 160 matched parents at 10 medical clinics across Canada. RESULTS: Participants' mean age was 14.3 years, 95% confidence interval (CI) [14.1-14.6]; 126 (75.8%) identified as boys, 32 (15.9%) girls, and 14 (8.3%) nonbinary. Average wait time after referral was 269 days (95% CI [244, 294]). Adolescents reported 13.5 months seeking gender-affirming medical care, longer than reported by their parents (p = .0001). Family physicians or pediatricians provided 68% of referrals. Prior to clinic, adolescents saw an average of 2.7 (maximum eight) different types of providers (95% CI [2.4, 2.9]). Indigenous background and greater number of types of providers seen were associated with longer time seeking care. The majority of adolescents had ever engaged in self-harm (67.6%), with 58.1% ever seriously considering suicide and 36.0% attempting. Previous self-harm and suicidal thoughts were associated with longer wait times and older age. Seventeen point seven percent of parents/caregivers reported their adolescents had participated in conversion therapy or that parents had considered it. DISCUSSION: The majority of participants were referred by family physicians or pediatricians, seeing multiple types of providers regarding their gender prior to referral. Adolescents experienced significant wait times. Indigenous adolescents reported longer times seeking care. Adolescents with longer wait times were more likely to have ever engaged in self-harm or had suicidal ideation.

A phase II dose evaluation pilot feasibility randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study).

BACKGROUND: Vitamin D deficiency (VDD) is highly prevalent in the pediatric intensive care unit (ICU) and associated with worse clinical course. Trials in adult ICU demonstrate rapid restoration of vitamin D status using an enteral loading dose is safe and may improve outcomes. There have been no published trials of rapid normalization of VDD in the pediatric ICU. METHODS: We conducted a multicenter placebo-controlled phase II pilot feasibility randomized clinical trial from 2016 to 2017. We randomized 67 critically ill children with VDD from ICUs in Canada, Chile and Austria using a 2:1 randomization ratio to receive a loading dose of enteral cholecalciferol (10,000 IU/kg, maximum of 400,000 IU) or placebo. Participants, care givers, and outcomes assessors were blinded. The primary objective was to determine whether the loading dose normalized vitamin D status (25(OH)D > 75 nmol/L). Secondary objectives were to evaluate for adverse events and assess the feasibility of a phase III trial. RESULTS: Of 67 randomized participants, one was withdrawn and seven received more than one dose of cholecalciferol before the protocol was amended to a single loading dose, leaving 59 participants in the primary analyses (40 treatment, 19 placebo). Thirty-one/38 (81.6%) participants in the treatment arm achieved a plasma 25(OH)D concentration > 75 nmol/L versus 1/18 (5.6%) the placebo arm. The mean 25(OH)D concentration in the treatment arm was 125.9 nmol/L (SD 63.4). There was no evidence of vitamin D toxicity and no major drug or safety protocol violations. The accrual rate was 3.4 patients/month, supporting feasibility of a larger trial. A day 7 blood sample was collected for 84% of patients. A survey administered to 40 participating families showed that health-related quality of life (HRQL) was the most important outcome for families for the main trial (30, 75%). CONCLUSIONS: A single 10,000 IU/kg dose can rapidly and safely normalize plasma 25(OH)D concentrations in critically ill children with VDD, but with significant variability in 25(OH)D concentrations. We established that a phase III multicentre trial is feasible. Using an outcome collected after hospital discharge (HRQL) will require strategies to minimize loss-to-follow-up. CLINICALTRIALS: gov NCT02452762 Registered 25/05/2015.

Implementation and evaluation of a longitudinal diabetes educational programme for adolescents.

INTRODUCTION: International guidelines recommend structured and continuous educational programmes to expand diabetes knowledge and self-efficacy in youth. To address these recommendations within a paediatric diabetes clinic, we conducted a three-phase quality improvement project aimed at improving adolescents' confidence in diabetes self-management skills. METHODS: In phase 1, the Diabetes Learning Centre (DLC), an educational programme for adolescents with type 1 diabetes (T1D) ages 13-17 years, was developed and implemented. Programme feasibility was evaluated through programme attendance rates. Phase 2 aimed to guide ongoing programme development and optimisation. DLC attendees rated their baseline confidence in overall and individual T1D self-management skills on a 5-point Likert scale. Patient characteristics were summarised using descriptive statistics and the association between patient characteristics and overall confidence in T1D self-management was evaluated. Phase 3 used patient surveys to evaluate patient satisfaction and reported change in confidence in self-management skills following DLC attendance. RESULTS: In phase 1, 232 (81%) of eligible adolescents attended the DLC during the study period. In phase 2, median overall confidence in diabetes management on a Likert scale (0-4) was 3, representing 'quite confident', although confidence was low in some essential self-management skills. Higher confidence was associated with lower HbA1c (p<0.001). In phase 3, 77 (85%) of participants reported high levels of satisfaction with the DLC. 106 (82%) of completed worksheets were associated with improved confidence in the diabetes self-management skill addressed. CONCLUSIONS: Implementation of a longitudinal T1D educational model was feasible with good uptake in an existing T1D programme. While confidence at baseline was quite high for overall T1D self-management, it was low in some essential self-management skills, highlighting the need for this programme and specific educational gaps. Adolescents reported improvements in confidence and high levels of satisfaction following DLC attendance. Our model provides a replicable programme template to address longitudinal education needs.

Improved Glycemia with Hybrid Closed-Loop Versus Continuous Subcutaneous Insulin Infusion Therapy: Results from a Randomized Controlled Trial.

Objective: To evaluate safety and effectiveness of MiniMed™ 670G hybrid closed loop (HCL) in comparison with continuous subcutaneous insulin infusion (CSII) therapy for 6 months in persons with type 1 diabetes (T1D). Methods: Adults (aged 18-80 years), adolescents, and children (aged 2-17 years) with T1D who were using CSII therapy were enrolled and randomized (1:1) to 6 months of HCL intervention (n = 151, mean age of 39.9 ± 19.8 years) or CSII without continuous glucose monitoring (n = 151, 35.7 ± 18.4 years). Primary effectiveness endpoints included change in A1C for Group 1 (baseline A1C >8.0%), from baseline to the end of study, and difference in the end of study percentage of time spent below 70 mg/dL (%TBR <70 mg/dL) for Group 2 (baseline A1C ≤8.0%), to show superiority of HCL intervention versus control. Secondary effectiveness endpoints were change in A1C and %TBR <70 mg/dL for Group 2 and Group 1, respectively, to show noninferiority of HCL intervention versus control. Primary safety endpoints were rates of severe hypoglycemia and diabetic ketoacidosis (DKA). Results: Change in A1C and difference in %TBR <70 mg/dL for the overall group were significantly improved, in favor of HCL intervention. In addition, a significant mean (95% confidence interval) change in A1C was observed for both Group 1 (-0.8% [-1.1% to -0.4%], P < 0.0001) and Group 2 (-0.3% [-0.5% to -0.1%], P < 0.0001), in favor of HCL intervention. The same was observed for difference in %TBR <70 mg/dL for Group 1 (-2.2% [-3.6% to -0.9%]) and Group 2 (-4.9% [-6.3% to -3.6%]) (P < 0.0001 for both). There was one DKA event during run-in and six severe hypoglycemic events: two during run-in and four during study (HCL: n = 0 and CSII: n = 4 [6.08 per 100 patient-years]). Conclusions: This RCT demonstrates that the MiniMed 670G HCL safely and significantly improved A1C and %TBR <70 mg/dL compared with CSII control in persons with T1D, irrespective of baseline A1C level.

Experiences and Stressors of Parents of Trans and Gender-Diverse Youth in Clinical Care from Trans Youth CAN!

Parents of trans and gender-diverse youth can experience challenges navigating gender-affirming (GA) care such as stigma, transphobia, and lack of support. There is little information available about stressors, worries, and positive feelings of parents as they try to support their youth accessing GA care. This article presents baseline survey data on experiences and stressors of 160 parents/caregivers in the Trans Youth CAN! cohort study, which examined medical, social, and family outcomes in youth age 16 years or younger considering puberty blockers or GA hormones. Data were collected at 10 Canadian gender clinics. Authors report on participating parents' characteristics, levels of support toward youth, stressors, worries, concerns, and positive feelings related to youth's gender. Most parent participants were White (85.1 percent), female (85.1 percent), birth or adoptive parents (96.1 percent), and reported strong support for youth's gender. Participants' concerns included their youth facing rejection (81.9 percent), generalized transphobia (74.6 percent), or encountering violence (76.4 percent). Parents also reported positive feelings about seeing their youth grow more confident. Most parental worries and stressors were situated outside the family, reflecting the systemic discrimination faced by youth and their families. Social workers could address these by developing systems-focused interventions and by further taking into account intersectional health disparities.

Developing a decision aid for youth with brachial plexus birth injuries facing treatment decisions for an elbow flexion contracture.

BACKGROUND: A common sequela of brachial plexus birth injury (BPBI) is an elbow flexion contracture. Youth with BPBI and their families face rehabilitation or surgical decisions that ideally entail careful deliberation of the risks and benefits of treatment within the context of the child's and family's functional and appearance-related goals. OBJECTIVE: To develop a patient decision aid (PtDA) following International Patient Decision Aid Standards to help these youth and their families make treatment decisions. DESIGN: Mixed-methods study. SETTING: Brachial plexus clinic in a pediatric tertiary care center. PARTICIPANTS: Five young adults (21-24 years), 14 youth (8-19 years) and their parents, 15 families (children 2-16 years), and 19 clinicians from a brachial plexus clinic participated in the PtDA development. Seventeen other youth (8-18 years) facing treatment decisions regarding their elbow contracture field tested the PtDA prototype. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: In-depth interviews and participant observation to conduct a decisional needs assessment of young adults, youth, parents, and health care professionals involved in these shared decisions. Cognitive interviews to field test the PtDA prototype. RESULTS: Evidence from previously conducted knowledge synthesis and the youth-focused decisional needs assessment qualitative data informed the development of new PtDA prototype, which included a questionnaire-based values clarification method for youth to rate what matters most to them regarding their elbow function, appearance, psychosocial impact, and treatment options. The majority (90%) of youth >11 years who field tested the PtDA prototype understood its content, whereas only 29% of those between 8 and 11 years demonstrated independent comprehension. The majority (69%) responded that they would prefer to use the PtDA on their own either at home or in the clinic waiting room. CONCLUSIONS: This new PtDA can be used to help youth with BPBI and their families to make a personal value-based informed decision regarding treatment options for their elbow flexion contracture.

Do Clinical Data from Transgender Adolescents Support the Phenomenon of "Rapid Onset Gender Dysphoria"?

Although emergence of gender dysphoria at puberty is long established, a distinct pathway of rapid onset gender dysphoria was recently hypothesized based on parental data. Using adolescent clinical data, we tested a series of associations that would be consistent with this pathway, however, our results did not support the rapid onset gender dysphoria hypothesis.

Transgender Youth Referred to Clinics for Gender-Affirming Medical Care in Canada.

BACKGROUND AND OBJECTIVES: Referrals of transgender and gender-diverse (trans) youth to medical clinics for gender-affirming care have increased. We described characteristics of trans youth in Canada at first referral visit. METHODS: Baseline clinical and survey data (2017-2019) were collected for Trans Youth CAN!, a 10-clinic prospective cohort of n = 174 pubertal and postpubertal youth <16 years with gender dysphoria, referred for hormonal suppression or hormone therapy, and 160 linked parent-participants. Measures assessed health, demographics, and visit outcome. RESULTS: Of youth, 137 were transmasculine (assigned female) and 37 transfeminine (assigned male); 69.0% were aged 14 to 15, 18.8% Indigenous, 6.6% visible minorities, 25.7% from immigrant families, and 27.1% low income. Most (66.0%) were gender-aware before age 12. Only 58.1% of transfeminine youth lived in their gender full-time versus 90.1% of transmasculine (P < .001). Although transmasculine youth were more likely than transfeminine youth to report depressive symptoms (21.2% vs 10.8%; P = .03) and anxiety (66.1% vs 33.3%; P < .001), suicidality was similarly high overall (past-year ideation: 34.5%, attempts: 16.8%). All were in school; 62.0% reported strong parental gender support, with parents the most common support persons (91.9%). Two-thirds of families reported external gender-related stressors. Youth had met with a range of providers (68.5% with a family physician). At clinic visit, 62.4% were prescribed hormonal suppression or hormone therapy, most commonly depot leuprolide acetate. CONCLUSIONS: Trans youth in Canada attending clinics for hormonal suppression or gender-affirming hormones were generally healthy but with depression, anxiety, and support needs.

Pubertal Suppression, Bone Mass, and Body Composition in Youth With Gender Dysphoria.

BACKGROUND AND OBJECTIVES: Puberty onset and development contribute substantially to adolescents' bone mass and body composition. Our objective with this study was to examine the effects of gonadotropin-releasing hormone agonists (GnRHa) on these puberty-induced changes among youth with gender dysphoria (GD). METHODS: Medical records of the endocrine diversity clinic in an academic children's hospital were reviewed for youth with GD seen from January 2006 to April 2017 with at least 1 baseline dual-energy radiograph absorptiometry measurement. RESULTS: At baseline, transgender females had lower lumbar spine (LS) and left total hip (LTH) areal bone mineral density (aBMD) and LS bone mineral apparent density (BMAD) z scores. Only 44.7% of transgender youth were vitamin D sufficient. Baseline vitamin D status was associated with LS, LTH aBMD, and LS BMAD z scores. Post-GnRHa assessments revealed a significant drop in LS and LTH aBMD z scores (transgender males and transgender females) without fractures and LS BMAD (transgender males), an increase in gynoid (fat percentage), and android (fat percentage) (transgender males and transgender females), and no changes in BMI z score. CONCLUSIONS: GnRHa monotherapy negatively affected bone mineral density of youth with GD without evidence of fractures or changes in BMI z score. Transgender youth body fat redistribution (android versus gynoid) were in keeping with their affirmed gender. The majority of transgender youth had vitamin D insufficiency or deficiency with baseline status associated with bone mineral density. Vitamin D supplementation should be considered for all youth with GD.

Motivational Stage at Continuous Glucose Monitoring (CGM) Initiation in Pediatric Type 1 Diabetes Is Associated With Current Glycemic Control but Does Not Predict Future CGM Adherence or Glycemic Control.

OBJECTIVES: The Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes (CGM TIME) Trial is a multicenter, randomized controlled trial in children with type 1 diabetes, comparing simultaneous pump and CGM with CGM initiation 6 months later (Paradigm, Veo, Enlite Sensor, Medtronic Canada). This study addresses the ability of SOCRATES (Stages Of Change Readiness And Treatment Eagerness Scale) to classify children and parents into distinct motivational stages and identify the stages' association with glycated hemoglobin (A1C) at trial entry and outcomes 6 months after CGM initiation. METHODS: Ninety-eight of 99 eligible children 10 to 18 years of age and 137 of 141 eligible parents completed SOCRATES at trial entry and 6 months later. Parent-child agreement for motivational stage was determined by weighted kappa. Linear regression was used to examine association between motivational stage and i) A1C at trial entry and ii) change in A1C and CGM adherence 6 months after CGM initiation. RESULTS: More than 87% of children and 88% of parents were classified into distinct motivational stages, with weak parent-child agreement. At trial entry, motivational stage was associated with A1C, which was 1.02% higher for children in the Action stage than in the Precontemplation stage (p<0.0001). When compared with children of parents in Precontemplation, A1C for children of parents in the Maintenance and Action stages were 0.83% (p=0.02) and 0.36% (p=0.048) higher, respectively. Precontemplation was associated with shorter diabetes duration. Motivational stage at CGM initiation did not predict change in A1C or CGM adherence 6 months later. CONCLUSIONS: SOCRATES can categorize children with type 1 diabetes and their parents into motivational stages. Although motivational stage was associated with glycemic control at trial entry, it did not predict future diabetes-related behaviour or A1C.

Gender diversity training in Canadian paediatric postgraduate medical education: A needs assessment survey.

OBJECTIVES: Evaluate the current state of postgraduate medical education on gender diversity in Canadian paediatric residency programs, exploring both resident and program director perceptions. BACKGROUND: Primary care providers are seeing more gender diverse children and youth in their offices, along with an exponential growth in referrals to Canadian specialty clinics and potential for significant mental health comorbidities. Gender-affirming support and management have been shown to improve overall outcomes. There is no mandatory curriculum on gender diversity for Canadian paediatric residency programs. METHODS: Cross-sectional online surveys in English and French distributed to program directors (PDs) and paediatric residents in the 17 Canadian paediatric residency programs. Data were analyzed by descriptive statistics with 95% confidence intervals. RESULTS: Response rate was 88.2% from PDs and 24.5% from paediatric residents. Among PDs, 14.3% (95% confidence interval [CI]: 6.3, 22.3) reported a formal curriculum for gender diversity teaching. Sixty-four per cent (53.3, 75.2) of PDs estimated their residents received ≤ 2 hours teaching on gender diversity. Residents reported comfort levels ≤ 50% on specific topics. Among residents, 73.8% (67.9, 79.6) reported that mandatory time in a gender diversity clinic would be the most effective teaching tool while PDs favoured an online module (66.7% [58.2, 75.1]). Barriers to more teaching included lack of time in a busy curriculum. Over 90% of resident indicated that more teaching on gender diversity is required. CONCLUSIONS: Significant variability in education on gender diversity is seen amongst Canadian paediatric residency programs. Discussion regarding a formal paediatric curriculum on gender diversity is needed.

Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial.

OBJECTIVE: To determine whether timing of CGM initiation offering low glucose suspend (LGS) affects CGM adherence in children and youth starting insulin pump therapy. METHODS: A 5-site RCT of pump-naïve subjects (aged 5-18 years) with type 1 diabetes (T1D) for at least 1 year compared simultaneous pump and CGM initiation offering LGS vs standard pump therapy with CGM initiation delayed for 6 months. Primary outcome was CGM adherence (hours per 28 days) (MiniMed™ Paradigm™ Veo™ system; CareLink Pro™ software) over 6 months after CGM initiation. Secondary outcome HbA1c was measured centrally. Linear mixed-models and ordinary least squares models were fitted to estimate effect of intervention, and covariates baseline age, T1D duration, HbA1c, gender, ethnicity, hypoglycemia history, clinical site, and association between CGM adherence and HbA1c. RESULTS: The trial randomized 144/152 (95%) eligible subjects. Baseline mean age was 11.5 ± 3.3(SD) years, T1D duration 3.4 ± 3.1 years, and HbA1c 7.9 ± 0.9%. Six months after CGM initiation, adjusted mean difference in CGM adherence was 62.4 hours per 28 days greater in the Simultaneous Group compared to Delayed Group (P = .007). There was no difference in mean HbA1c at 6 months. However, for each 100 hours of CGM use per 28-day period, HbA1c was 0.39% (95% CI 0.10%-0.69%) lower. Higher CGM adherence was associated with reduced time with glucose >10 mmol/L (P < .001). CONCLUSION: CGM adherence was higher after 6 months when initiated at same time as pump therapy compared to starting CGM 6 months after pump therapy. Greater CGM adherence was associated with improved HbA1c.

Fear of hypoglycemia in children with type 1 diabetes and their parents: Effect of pump therapy and continuous glucose monitoring with option of low glucose suspend in the CGM TIME trial.

To determine if pump therapy with continuous glucose monitoring offering low glucose suspend (LGS) decreases fear of hypoglycemia among children with type 1 diabetes and their parents. The CGM TIME trial is a multicenter randomized controlled trial that enrolled 144 children with type 1 diabetes for at least 1 year (mean duration 3.4 ± 3.1 years) starting pump therapy (MiniMed™ Veo™, Medtronic Canada). CGM (MiniMed™ Enlite™ sensor) offering LGS was introduced simultaneously or delayed for 6 months. Hypoglycemia Fear Scale (HFS) was completed by children ≥10 years old and all parents, at study entry and 12 months later. Simultaneous and Delayed Group participants were combined for all analyses. Subscale scores were compared with paired t-tests, and individual items with paired Wilcoxon tests. Linear regression examined association with CGM adherence. 121/140 parents and 91/99 children ≥10 years had complete data. Mean Behavior subscale score decreased from 21.1 (SD 5.9) to 17.2 (SD 6.1) (p < .001) for children, and 20.7 (SD 7.5) to 17.4 (7.4) (p < .001) for parents. Mean Worry subscale score decreased from 17.9 (SD 11.9) to 11.9 (SD 11.4) (p < .001) for children, and 23.1 (SD 13.2) to 17.6 (SD 10.4) (p < .001) for parents. Median scores for 10/25 child items and 12/25 parent items were significantly lower at 12 months (p < .001). Linear regression found no association between HFS scores and CGM adherence. Insulin pump therapy with CGM offering LGS significantly reduced fear of hypoglycemia not related to CGM adherence in children with type 1 diabetes and their parents.

Prevention of post-cardiac surgery vitamin D deficiency in children with congenital heart disease: a pilot feasibility dose evaluation randomized controlled trial.

BACKGROUND: The vast majority of children undergoing cardiac surgery have low vitamin D levels post-operative, which may contribute to greater illness severity and worse clinical outcomes. Prior to the initiation of a large phase III clinical trial focused on clinical outcomes, studies are required to evaluate the feasibility of the study protocol, including whether the proposed dosing regimen can safely prevent post-operative vitamin D deficiency in this high-risk population. METHODS: We conducted a two-arm, double-blind dose evaluation randomized controlled trial in children requiring cardiopulmonary bypass for congenital heart disease. Pre-operatively, participants were randomized to receive cholecalciferol representing usual care (< 1 year = 400 IU/day, > 1 year = 600 IU/day) or a higher dose approximating the Institute of Medicine tolerable upper intake level (< 1 year = 1600 IU/day, > 1 year = 2400 IU/day). The feasibility outcomes were post-operative vitamin D status (primary), vitamin D-related adverse events, accrual rate, study withdrawal rate, blinding, and protocol non-adherence. RESULTS: Forty-six children were randomized, and five withdrew prior to surgery, leaving 41 children (21 high dose, 20 usual care) in the final analysis. The high dose group had higher 25-hydroxyvitamin D concentrations both intraoperatively (mean difference + 25.9 nmol/L; 95% CI 8.3-43.5) and post-operatively (mean difference + 17.2 nmol/L; 95% CI 5.5-29.0). Fewer participants receiving high-dose supplementation had post-operative serum 25-hydroxyvitamin D concentrations under 50 nmol/L, compared with usual care (RR 0.31, 95% CI 0.11-0.87). Post-operative vitamin D status was associated with the treatment arm and the number of doses received. There were no cases of hypercalcemia, and no significant adverse events related to vitamin D. While only 75% of the target sample size was recruited (limited funding), the consent rate (83%), accrual rate (1.5 per site month), number of withdrawals (11%), and ability to maintain blinding support feasibility of a larger trial. CONCLUSIONS: Pre-operative daily high-dose supplementation improved vitamin D status pre-operatively and at time of pediatric ICU admission. The protocol for a more definitive trial should limit enrollment of children with at least 30 days between randomization and surgery to allow adequate duration of supplementation or consider a loading dose. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01838447. Registered on April 24, 2013.

Screening and Treatment Outcomes in Adults and Children With Type 1 Diabetes and Asymptomatic Celiac Disease: The CD-DIET Study.

OBJECTIVE: To describe celiac disease (CD) screening rates and glycemic outcomes of a gluten-free diet (GFD) in patients with type 1 diabetes who are asymptomatic for CD. RESEARCH DESIGN AND METHODS: Asymptomatic patients (8-45 years) were screened for CD. Biopsy-confirmed CD participants were randomized to GFD or gluten-containing diet (GCD) to assess changes in HbA1c and continuous glucose monitoring over 12 months. RESULTS: Adults had higher CD-seropositivity rates than children (6.8% [95% CI 4.9-8.2%, N = 1,298] vs. 4.7% [95% CI 3.4-5.9%, N = 1,089], P = 0.035) with lower rates of prior CD screening (6.9% vs. 44.2%, P < 0.0001). Fifty-one participants were randomized to a GFD (N = 27) or GCD (N = 24). No HbA1c differences were seen between the groups (+0.14%, 1.5 mmol/mol; 95% CI -0.79 to 1.08; P = 0.76), although greater postprandial glucose increases (4-h +1.5 mmol/L; 95% CI 0.4-2.7; P = 0.014) emerged with a GFD. CONCLUSIONS: CD is frequently observed in asymptomatic patients with type 1 diabetes, and clinical vigilance is warranted with initiation of a GFD.

Decision coaching using a patient decision aid for youth and parents considering insulin delivery methods for type 1 diabetes: a pre/post study.

BACKGROUND: Choice of insulin delivery for type 1 diabetes can be difficult for many parents and children. We evaluated decision coaching using a patient decision aid for helping youth with type 1 diabetes and parents decide about insulin delivery method. METHODS: A pre/post design. Youth and parent(s) attending a pediatric diabetes clinic in a tertiary care centre were referred to the intervention by their pediatric endocrinologist or diabetes physician between September 2013 and May 2015. A decision coach guided youth and their parents in completing a patient decision aid that was pre-populated with evidence on insulin delivery options. Primary outcomes were youth and parent scores on the low literary version of the validated Decisional Conflict Scale (DCS). RESULTS: Forty-five youth (mean age = 12.5 ± 2.9 years) and 66 parents (45.8 ± 5.6 years) participated. From pre- to post-intervention, youth and parent decisional conflict decreased significantly (youth mean DCS score was 32.0 vs 6.6, p < 0.0001; parent 37.6 vs 3.5, p < 0.0001). Youth's and parents' mean decisional conflict scores were also significantly improved for DCS subscales (informed, values clarity, support, and certainty). 92% of youth and 94% of parents were satisfied with the decision coaching and patient decision aid. Coaching sessions averaged 55 min. Parents (90%) reported that the session was the right length of time; some youth (16%) reported that it was too long. CONCLUSION: Decision coaching with a patient decision aid reduced decisional conflict for youth and parents facing a decision about insulin delivery method.

Closing the Gap: Results of the Multicenter Canadian Randomized Controlled Trial of Structured Transition in Young Adults With Type 1 Diabetes.

OBJECTIVE: To determine if a structured transition program for young adults with type 1 diabetes improves clinic attendance, glycemic control, diabetes-related distress, quality of life, and satisfaction with care. RESEARCH DESIGN AND METHODS: In this multicenter randomized controlled trial, young adults (17-20 years) with type 1 diabetes were randomly assigned to a transition program with a transition coordinator or to standard care. The intervention lasted 18 months (6 in pediatric and 12 in adult care). The primary outcome was the proportion of participants who failed to attend at least one adult diabetes clinic visit during the 12-month follow-up after completion of the intervention. RESULTS: We randomized 205 participants, 104 to the transition program and 101 to standard care. Clinic attendance was improved in the transition program (mean [SD] number of visits 4.1 [1.1] vs. 3.6 [1.2], P = 0.002), and there was greater satisfaction with care (mean [SD] score 29.0 [2.7] vs. 27.9 [3.4], P = 0.032) and less diabetes-related distress (mean [SD] score 1.9 [0.8] vs. 2.1 [0.8], P = 0.049) reported than in standard care. There was a trend toward improvement in mean HbA1c (8.33% [68 mmol/mol] vs. 8.80% [73 mmol/mol], P = 0.057). During the 12-month follow-up, there was no difference in those failing to attend at least one clinic visit (P = 0.846), and the mean change in HbA1c did not differ between the groups (P = 0.073). At completion of follow-up, the groups did not differ with respect to satisfaction with care or diabetes-related distress and quality of life. CONCLUSIONS: Transition support during this 18-month intervention was associated with increased clinic attendance, improved satisfaction with care, and decreased diabetes-related distress, but these benefits were not sustained 12 months after completion of the intervention.

Exploring the Decisional needs of Parents with Children with ADHD and Disruptive and Aggressive Behaviour.

OBJECTIVE: The aim of this qualitative study was to explore the decisional needs of parents of children with ADHD and disruptive and aggressive behaviour to inform the creation of a patient decision aid. METHOD: A one-day meeting of researchers, community advocacy partners, and 11 parents of children (age range eight to 21) with aggressive and disruptive behaviour associated with a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder or Conduct Disorder was held. This meeting consisted of a two-hour educational session on the assessment and management of aggressive and disruptive behaviour in children and patient decision aids, followed by two concurrent focus groups to determine the decisional needs of parents. NVivo11 software was used for the organization of the data. RESULTS: The results outline the broad themes and subthemes that emerged from the thematic analysis. These themes and subthemes include (a) decisional needs - treatment options and where to begin, availability, effectiveness of different treatment options, side effects, time, depth of information provided; (b) decision aid formats, and (c) accessibility - language, involvement of children, and dissemination. CONCLUSION: The themes generated from the focus groups suggest that a patient decision aid for parents with children with ADHD and disruptive and aggressive behaviour should follow the general recommendations for best practices for the creation of patient decision aids. Specific information on the regional availability of non-medical treatments will be especially helpful for parents to navigate services and service providers. Consideration should be given as to how the concept of values clarification is introduced to families.

OBJECTIF: Cette étude qualitative visait à explorer les besoins décisionnels de parents d'enfants souffrant du trouble de déficit de l'attention avec hyperactivité (TDAH) et présentant un comportement perturbateur et agressif, dans le but de renseigner la création d'un outil de prise de décision pour les patients. MÉTHODE: Une réunion d'un jour de chercheurs, de partenaires de défense communautaire et de 11 parents d'enfants (de 8 à 21 ans) présentant un comportement agressif et perturbateur associé à un diagnostic de TDAH, de trouble oppositionnel avec provocation ou de trouble des conduites a eu lieu. Cette réunion consistait en une séance éducative de 2 heures sur l'évaluation et la gestion du comportement agressif et perturbateur des enfants et sur les outils de prise de décision des patients, suivie de 2 groupes de discussion simultanés pour déterminer les besoins décisionnels des parents. L'organisation des données s'est faite à l'aide du logiciel NVivo11. RÉSULTATS: Les résultats font ressortir les grands thèmes et sous-thèmes qui sont issus de l'analyse thématique. Ces thèmes et sous-thèmes sont notamment (a) les besoins décisionnels ­ les options de traitement et par où commencer, la disponibilité, l'efficacité des différentes options de traitement, les effets secondaires, le temps, l'exhaustivité de l'information fournie; (b) les formats des outils de prise de décision, et (c) l'accessibilité ­ la langue, la participation des enfants, et la diffusion. CONCLUSION: Les thèmes issus des groupes de discussion suggèrent qu'un outil de prise de décision des patients destiné aux parents d'enfants qui souffrent de TDAH et présentent un comportement agressif et perturbateur devrait suivre les recommandations générales des pratiques exemplaires pour la création d'un outil de prise de décision des patients. L'information spécifique sur la disponibilité régionale des traitements non médicaux sera particulièrement utile pour les parents qui cherchent des services et des fournisseurs de service. Il serait bon d'examiner comment le concept de la clarification des valeurs est présenté aux familles.