Severe obesity and global developmental delay in preschool children: Findings from a Canadian Paediatric Surveillance Program study.

Background: The co-presentation of severe obesity (SO) and global developmental delay (GDD) in Canadian preschool children has not been examined. However, SO and GDD may require syndromic diagnoses and unique management considerations. Objectives: To determine (1) minimum incidence; (2) age of onset and risk factors; and (3) health care utilization for co-presenting SO and GDD. Methods: Through the Canadian Paediatric Surveillance Program (CPSP), a monthly form was distributed to participants from February 2018 to January 2020 asking for reports of new cases of SO and GDD among children ≤5 years of age. We performed descriptive statistics for quantitative questions and qualitative content analysis for open-ended questions. Results: Forty-seven cases (64% male; 51% white; mean age: 3.5 ± 1.2 years) were included. Age of first weight concern was 2.5 ± 1.3 years and age of GDD diagnosis was 2.7 ± 1.4 years. Minimum incidence of SO and GDD was 3.3 cases per 100,000 for ≤5 years of age per year. Identified problems included school and/or behavioural problems (n = 17; 36%), snoring (n = 14; 30%), and asthma/recurrent wheeze (n = 10; 21%). Mothers of 32% of cases (n = 15) had obesity and 21% of cases (n = 10) received neonatal intensive care. Microarray was ordered for 57% (n = 27) of children. A variety of clinicians and services were accessed. As reported by CPSP participants, challenges faced by families and health service access were barriers to care. Conclusion: Children with SO and GDD have multiple comorbidities, and require early identification and referral to appropriate services. These cases may also benefit from additional testing to rule out known genetic obesity syndromes.

A Randomized Crossover Trial to Compare Automated Insulin Delivery (the Artificial Pancreas) With Carbohydrate Counting or Simplified Qualitative Meal-Size Estimation in Type 1 Diabetes.

OBJECTIVE: Qualitative meal-size estimation has been proposed instead of quantitative carbohydrate (CHO) counting with automated insulin delivery. We aimed to assess the noninferiority of qualitative meal-size estimation strategy. RESEARCH DESIGN AND METHODS: We conducted a two-center, randomized, crossover, noninferiority trial to compare 3 weeks of automated insulin delivery with 1) CHO counting and 2) qualitative meal-size estimation in adults with type 1 diabetes. Qualitative meal-size estimation categories were low, medium, high, or very high CHO and were defined as <30 g, 30-60 g, 60-90 g, and >90 g CHO, respectively. Prandial insulin boluses were calculated as the individualized insulin to CHO ratios multiplied by 15, 35, 65, and 95, respectively. Closed-loop algorithms were otherwise identical in the two arms. The primary outcome was time in range 3.9-10.0 mmol/L, with a predefined noninferiority margin of 4%. RESULTS: A total of 30 participants completed the study (n = 20 women; age 44 (SD 17) years; A1C 7.4% [0.7%]). The mean time in the 3.9-10.0 mmol/L range was 74.1% (10.0%) with CHO counting and 70.5% (11.2%) with qualitative meal-size estimation; mean difference was -3.6% (8.3%; noninferiority P = 0.78). Frequencies of times at <3.9 mmol/L and <3.0 mmol/L were low (<1.6% and <0.2%) in both arms. Automated basal insulin delivery was higher in the qualitative meal-size estimation arm (34.6 vs. 32.6 units/day; P = 0.003). CONCLUSIONS: Though the qualitative meal-size estimation method achieved a high time in range and low time in hypoglycemia, noninferiority was not confirmed.

Behavioral and emotional characteristics of Canadian children with obesity and moderate-severe sleep-disordered breathing treated with positive airway pressure: longitudinal changes and associations with adherence.

STUDY OBJECTIVES: Behavioral characteristics and outcomes of positive airway pressure (PAP) therapy in children with obesity and moderate-severe sleep-disordered breathing (SDB) have not been reported. Our aims were to 1) determine baseline behavioral/emotional symptoms of this population and characterize changes over time with PAP, and 2) examine associations between baseline behavioral/emotional symptoms and PAP adherence. METHODS: This multicenter prospective cohort study of children with obesity prescribed PAP for moderate-severe SDB assessed PAP adherence (≥ 4 h/night, >50% of nights, usage diaries, downloads) and compared behavioral/emotional characteristics with parent- and child-reported Conners Rating Scale (Conners) and the Child Behavior Checklist (CBCL) at baseline and 1 year after PAP prescription between adherent and nonadherent participants; scores at baseline were compared retrospectively between adherence groups. RESULTS: Twenty-four children were included (median 14.1 years [IQR:12.4,16.0]; 87.5% males). Baseline Conners and CBCL scores were elevated (parent- and child-reported Conners inattention and hyperactivity subscales and CBCL subscales [total, internalizing, externalizing]). Baseline parent-reported Conners scores were significantly more elevated in the nonadherent than adherent group (inattention: 73.3 ± 8.5 vs 60.5 ± 14.6, P = .01; hyperactivity: 70.9 ± 11.1 vs 59.1 ± 16.0, P = .05). This difference was present 1 year later for inattention (P = .01) but not for hyperactivity (P = .09). Parent-reported CBCL scores improved over 1 year in adherent but not nonadherent participants. CONCLUSIONS: We found that children with obesity and moderate-severe SDB have elevated symptoms of behavioral/emotional concerns on standardized testing. Parent-reported emotional characteristics improved in the adherent but not in the nonadherent group. Children with greater inattention/hyperactivity at baseline were less adherent to PAP, suggesting this may contribute to PAP nonadherence. CITATION: Constantin E, MacLean JE, Barrowman N, et al. Behavioral and emotional characteristics of Canadian children with obesity and moderate-severe sleep-disordered breathing treated with positive airway pressure: longitudinal changes and associations with adherence. J Clin Sleep Med. 2023;19(3):555-562.

Associations Between Socioeconomic Status and Patient Experience With Type 1 Diabetes Management and Complications: Cross-sectional Analysis of a Cohort From Québec, Canada.

BACKGROUND: Low socioeconomic status (SES) may add to the challenges of type 1 diabetes (T1D) management and be an independent risk factor for chronic and acute diabetes complications. Our aim in this study was to evaluate the association between SES and TID management and risk of complications in a universal health-care system using data from a registry of people living with T1D (PWT1D) in Québec, Canada (the BETTER registry). METHODS: This study was a cross-sectional analysis describing the association between SES factors (education, income, employment and insurance coverage) and T1D outcomes (glycated hemoglobin [A1C], acute and chronic complications and comorbidities), using chi-square tests and regression analyses (adjusted for diabetes duration, sex, ethnicity and diabetes technology use). RESULTS: In a sample of 1,333 PWT1D, lower education level was associated with cardiovascular disease (odds ratio [OR], 2.44; p=0.002), depression (OR, 1.56; p=0.020), nephropathy (OR, 2.10; p=0.001) and higher A1C (OR, 1.79; p<0.001). Low-income groups were more likely to report higher A1C (OR, 2.16; p=0.001), retinopathy (OR, 1.84; p=0.038), neuropathy (OR, 1.89; p=0.043), nephropathy (OR, 2.23; p=0.024), severe hypoglycemia (OR, 1.87; p=0.022) and depression (OR, 1.87; p=0.012). Unemployment was associated with retinopathy (OR, 2.37; p=0.009) and neuropathy (OR, 1.96; p=0.035). Diabetic ketoacidosis (OR, 2.81; p=0.001) and neuropathy (OR, 1.67; p=0.020) were more likely to be reported by participants with public insurance. CONCLUSIONS: PWT1D from lower SES, particularly those with low income and low education, were more likely to report T1D-related complications and comorbidities. Further longitudinal investigations are needed to better understand the nature and directionality of these associations.

Nutrition and food literacy among young Canadian adults living with type 1 diabetes.

AIM: Nutrition and food literacy encompasses knowledge, skills and confidence to prepare healthy meals. This project aimed to assess and compare the proportion of young Canadian adults (18-29 years old) living with type 1 diabetes and without diabetes (controls) who demonstrated adequate nutritional health literacy. METHODS: This cross-sectional study involved participants completing an online survey that included questions on socio-economic status, nutrition knowledge, confidence and skills in meal preparation and the Short Food Literacy Questionnaire (SFLQ). Proportion of participants with adequate SFLQ score (i.e. ≥34/52) was compared between the groups (two-sample t-test). RESULTS: Among the 236 people living with type 1 diabetes and 191 controls (81.5% women), mean age was 24 ± 3 years for people living with type 1 diabetes and 22 ± 3 years for controls (p < 0.001). More people living with type 1 diabetes reported adequate SFLQ score (people living with type 1 diabetes 88.0% vs. Controls 68.0%; p < 0.001). Similarly, majority of people living with type 1 diabetes prepared their own meals compared to the controls (74.5% vs. 47.6%; p < 0.001). Enhanced SFLQ score was associated with higher cooking skills (p = 0.02) and confidence (p < 0.01) in preparing healthy meals. CONCLUSIONS: Living with type 1 diabetes was associated with greater SFLQ scores among young Canadian adults. Having the independence, the confidence and skills in meal preparation were contributing factors.

Comparison of Nocturnal Glucose After Exercise Among Dual-Hormone, Single-Hormone Algorithm-Assisted Insulin Delivery System and Usual Care in Adults and Adolescents Living with Type 1 Diabetes: A Pooled Analysis.

Background: Available studies comparing the efficacy of dual-hormone (DH)-algorithm-assisted insulin delivery (AID), single-hormone (SH)-AID and usual care on postexercise overnight glucose in people with type 1 diabetes (T1D) have had different outcomes. By pooling data from all available studies, we aim to draw stronger conclusions. Methods: Data were pooled from two three-arm, open-label, randomized, controlled, crossover studies. Forty-one adults [median (Q1, Q3) age: 34.0 years (29.5, 51.0), mean HbA1c: 7.5% ± 1.0%] and 17 adolescents with T1D [age: 14.0 (13.0, 16.0), HbA1c: 7.8% ± 0.8%] underwent DH-AID, SH-AID, and usual care. Each intervention involved evening aerobic exercise (60-min). The primary outcome, time in range% (TIR%) overnight (00:00-06:00) postexercise based on continuous glucose monitoring, was compared among treatments using linear mixed effect model or generalized linear mixed model. Results: Among adults, mean TIR% was 94.0% ± 11.9%, 83.1% ± 20.5%, and 65.1% ± 37.0% during DH-AID, SH-AID, and usual care intervention, respectively (P < 0.05 for all between-group comparisons). DH-AID was superior to SH-AID and usual care, and SH-AID was superior to usual care regarding hypoglycemia and hyperglycemia prevention, but not glycemic variability. Among adolescents, DH-AID and SH-AID reduced dysglycemia, but not glycemic variability, better than usual care. Glycemic outcomes were similar between DH-AID and SH-AID. Conclusion: AID systems allow improved postexercise nocturnal glycemic management than usual care for both adults and adolescents. DH-AID was better than SH-AID among adults, but not adolescents.

Overweight and obese youth with type 1 or type 2 diabetes share similar elevation in triglycerides during middle and late adolescence.

BACKGROUND: Overweight and obesity have been observed in children with type 1 diabetes (T1D). This further increases their future risk of Cardiovascular Disease (CVD) as well as the development of other risk factors, such as dyslipidemia. AIMS: To compare lipid profiles in children and adolescents with Type 1 diabetes and lean mass (T1L), Type 1 diabetes and overweight or obese (T1OW/OB), and type 2 diabetes (T2D). METHODS: This was a cross-sectional study of 669 patients with T1D or T2D aged 2-19 years using retrospective data collected from 2003 to 2014. Included patients were categorized into lean (BMI < 85th ile and overweight or Obese (BMI ≥ 85th ile). Patients were subcategorized into three age groups: < 10 years, 10-14 years, and 15-19 years. RESULTS: 7.6% of patients had T2D. Of the patients with T1D, 58.9% were lean, 26.4% were overweight, and 14.7% were obese. Total Cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C) and Non-HDL-C levels were similar across groups. In the 15-19 years group, Triglycerides (TG) levels were significantly higher in T1OW/OB and similar to T2D. High-density lipoprotein Cholesterol (HDL-C) was significantly lower in T2D. Weight status significantly correlated with TG and HDL-C levels in T1D and T2D groups. CONCLUSIONS: T1OW/OB constitutes a significant proportion of the T1D population. Patients with obesity and T1D, especially if in their late adolescence, have an adverse lipid profile pattern that is comparable to adolescents with T2D. Based on these findings, risk for future CVD in T1OW/OB and T2D may be equivalent.

Increasing Incidence of Type 1 and Type 2 Diabetes Among Canadian Children.

BACKGROUND: Diabetes mellitus is one of the most common pediatric chronic illnesses. Although a rising incidence of childhood type 1 diabetes (T1D) has frequently been documented, an almost 400-fold variation in incidence has been seen worldwide. We aimed to describe the trends in incidence of diabetes (type 1, type 2, all types) among children and adolescents living in the Greater Montréal area of Québec, Canada. METHODS: Using health administrative data (Québec Integrated Chronic Disease Surveillance System) and medical records from the 3 major pediatric diabetes centres in the Greater Montréal area, we conducted serial cross-sectional studies of children aged 1 to 15 years during the period from 2002 to 2010. We conducted a trend analysis of diabetes incidence over time using multivariate Poisson regression models. RESULTS: We identified 696 new cases of diabetes between 2002 and 2010. The age-standardized incidence of diabetes (all types) increased from 16.3 (95% confidence interval [CI], 12.4 to 21.2) to 27.8 (95% CI, 22.5 to 34.0) per 100,000, with annual incidence increasing, on average, by 5.2% per year (adjusted rate ratio [aRR], 1.052; 95% CI, 1.022 to 1.083). This was driven predominantly by the T1D annual increase of 5.4% (aRR, 1.054; 95% CI, 1.023 to 1.086). A low number of incident cases of type 2 diabetes limited trend analysis in this group. There were no significant interactions between year and sex or age. CONCLUSIONS: The annual incidence of T1D is increasing in Québec children and does not vary by sex or age. Further research into etiologic factors is indicated.

Anticipated Basal Insulin Reduction to Prevent Exercise-Induced Hypoglycemia in Adults and Adolescents Living with Type 1 Diabetes.

Objective: We investigated the effect of two key timings for basal insulin rate reduction on exercise-induced glucose changes and explored the association between circulating insulin concentrations and muscle vasoreactivity. Research Design and Methods: Twenty adults and adolescents performed 60-min exercise sessions (ergocycle) at 60% VO2peak, 240 min after a standardized lunch. In a randomized order, we compared an 80% basal insulin reduction applied 40 min (T-40) or 90 min (T-90) before exercise onset. Near-infrared spectroscopy was used to investigate muscle hemodynamics at vastus lateralis. Glucose and insulin plasma concentrations were measured. Results: Reduction in plasma glucose (PG) level during exercise was attenuated during T-90 versus T-40 strategy (-0.89 ± 1.89 mmol/L vs. -2.17 ± 2.49 mmol/L, respectively; P = 0.09). Linear mixed model analysis showed that PG dropped by an additional 0.01 mM per minute in T-40 versus T-90 (time × strategy interaction, P < 0.05). The absolute number of hypoglycemic events was not different between the two strategies, but they occurred later with T-90. Free insulin tends to decrease more during the pre-exercise period in the T-90 strategy (P = 0.08). Although local muscle vasodilatation (ΔTHb) was comparable between the two strategies, we found that PG dropped more in cases of higher exercise-induced skeletal muscle vasodilatation (ΔTHb × time interaction P < 0.005, e: -0.0086 mM/min and additional mM of ΔTHb). Conclusion: T-90 timing reduced exercise-induced drop in PG and delayed the occurrence of hypoglycemic episodes compared with T-40 timing without a significant reduction in the number of events requiring treatment. Trial registration: ClinicalTrials.gov identifier: NCT03349489.

Individual and family characteristics associated with health indicators at entry into multidisciplinary pediatric weight management: findings from the CANadian Pediatric Weight management Registry (CANPWR).

OBJECTIVES: (1) To explore individual and family characteristics related to anthropometric and cardiometabolic health indicators and (2) examine whether characteristics that correlate with cardiometabolic health indicators differ across severity of obesity at time of entry to Canadian pediatric weight management clinics. METHODS: We conducted a cross-sectional analysis of 2-17 year olds with overweight or obesity who registered in the CANadian Pediatric Weight Management Registry (CANPWR) between May 2013 and October 2017 prior to their first clinic visit. Individual modifiable health behaviors included dietary intake, physical activity, screen time, and sleep. Family characteristics included parental BMI, family medical history, socioeconomic status and family structure. Linear mixed effects stepwise regression analysis was performed to determine which characteristics were related to each health indicator: BMI z-score; waist circumference; waist to height ratio; blood pressure; glycemia; HDL cholesterol; non-HDL cholesterol; triglycerides. RESULTS: This study included 1296 children (mean age ± standard deviation: 12.1 ± 3.5 years; BMI z-score: 3.55 ± 1.29; 95.3% with obesity). Hours spent sleeping (estimated ß = -0.10; 95% CI [-0.15, -0.05], p = 0.0001), hours per week of organized physical activity (estimated ß = -0.32; 95% CI [-0.53, -0.11], p = 0.0026), daily sugared drink intake (estimated ß = 0.06; 95% CI [0.01, 0.10], p = 0.0136) and maternal BMI (estimated ß = 0.03; 95% CI [0.02, 0.04], p < 0.0001) were associated with BMI z-score (adj. R2 = 0.2084), independent of other individual and family characteristics. Physical activity, total sugared drink intake and sleep duration were associated with glycemia and non-HDL cholesterol, independent of child BMI z-score. However, irrespective of obesity severity, little of the variance (0.86-11.1%) in cardiometabolic health indicators was explained by individual modifiable health behaviors. CONCLUSIONS: Physical activity, total sugared drink intake and hours spent sleeping were related to anthropometric and some cardiometabolic health indicators in children entering pediatric weight management programs. This highlights the importance of these modifiable health behaviors on multiple health indicators in children with obesity.

Metabolically healthy obesity in children enrolled in the CANadian Pediatric Weight management Registry (CANPWR): An exploratory secondary analysis of baseline data.

Our study purpose was to determine the prevalence of metabolically healthy obesity (MHO) and examine factors associated with MHO in children with obesity. This cross-sectional study was a secondary, exploratory analysis of data that included 2-17 years old with a body mass index (BMI) ≥85th percentile from the CANadian Pediatric Weight management Registry. Children were classified as having MHO or metabolically unhealthy obesity (MUO) using consensus-based criteria. Those with MHO had normal triglycerides, high-density lipoprotein cholesterol, blood pressure, and fasting glucose. Logistic regression was used to examine factors associated with MHO, which included calculating odds ratios (ORs) and 95% confidence intervals (CIs). In total, 945 children were included (mean age: 12.3 years; 51% female). The prevalence of MHO was 31% (n = 297), with lower levels across increasing age categories (2-5 years [n = 18; 43%], 6-11 years [n = 127; 35%], 12-17 years [n = 152; 28%]). Children with MHO were younger, weighed less, and had lower BMI z-scores than their peers with MUO (all p < 0.01). MHO status was positively associated with physical activity (OR: 1.18; 95% CI: 1.01-1.38), skim milk intake (OR: 1.10; 95% CI: 1.01-1.19), and fruit intake (OR: 1.12; 95% CI: 1.01-1.24) and negatively associated with BMI z-score (OR: 0.69; 95% CI: 0.60-0.79), total screen time in hours (OR: 0.79; 96% CI: 0.68-0.92), and intake of fruit flavoured drinks (OR: 0.91; 95% CI: 0.84-0.99). These findings may help guide clinical decision-making regarding obesity management by focusing on children with MUO who are at relatively high cardiometabolic risk.

A fully artificial pancreas versus a hybrid artificial pancreas for type 1 diabetes: a single-centre, open-label, randomised controlled, crossover, non-inferiority trial.

BACKGROUND: For people with type 1 diabetes, there is currently no automated insulin delivery system that does not require meal input. We aimed to assess the efficacy of a novel faster-acting insulin aspart (Fiasp) plus pramlintide fully closed-loop system that does not require meal input. METHODS: In this open-label, randomised controlled, crossover, non-inferiority trial we compared the Fiasp (Novo Nordisk, Bagsværd, Denmark) plus pramlintide closed-loop system with no meal input (fully artificial pancreas) and the Fiasp-alone closed-loop system with precise carbohydrate counting (hybrid artificial pancreas). Adults (≥18 years) who had a clinical diagnosis of type 1 diabetes for at least 12 months, had glycated haemoglobin 12% or lower, and had been on insulin pump therapy for at least 6 months were enrolled at McGill University Health Centre, Montreal, QC, Canada. The Fiasp plus pramlintide fully closed-loop system delivered pramlintide in a basal-bolus manner with a fixed ratio of 10 µg:U relative to insulin. A research staff member counted the carbohydrate content of meals to input in the hybrid closed-loop system. Participants completed the two full-day crossover interventions in a random order allocated by a computer-generated code implementing a blocked randomisation (block size of four). The primary outcome was the percentage of time spent within the glucose target range (3·9-10·0 mmol/L), with a 6% non-inferiority margin, assessed in all participants who completed both interventions. This trial is registered with ClinicalTrials.gov, NCT03800875. FINDINGS: Between Feb 8, 2019, and Sept 19, 2020, we enrolled 28 adults, of whom 24 completed both interventions and were included in analyses. The percentage of time spent in the target range was 74·3% (IQR 61·5-82·8) with the fully closed-loop system versus 78·1% (66·3-87·5) with the hybrid Fiasp-alone closed-loop system (paired difference 2·6%, 95% CI -2·4 to 12·2; non-inferiority p=0·28). Eight (33%) participants had at least one hypoglycaemia event (<3·3 mmol/L) with the fully closed-loop system compared with 14 (58%) participants with the hybrid closed-loop system (2200-2200 h). Non-mild nausea was reported by three (13%) participants and non-mild bloating by one (4%) participant with the fully closed-loop system compared with zero participants with the hybrid closed-loop system. INTERPRETATION: The Fiasp plus pramlintide fully closed-loop system was not non-inferior to the Fiasp-alone hybrid closed-loop system for the overall percentage of time in the glucose target range. However, participants still spent a high percentage of time within the target range with the fully-closed loop system. Outpatient studies comparing the fully closed-loop hybrid systems with patient-estimated, rather than precise, carbohydrate counting are warranted. FUNDING: Diabetes Canada.

Alleviating carbohydrate counting with a FiASP-plus-pramlintide closed-loop delivery system (artificial pancreas): Feasibility and pilot studies.

AIM: To assess whether a FiASP-and-pramlintide closed-loop system has the potential to replace carbohydrate counting with a simple meal announcement (SMA) strategy (meal priming bolus without carbohydrate counting) without degrading glycaemic control compared with a FiASP closed-loop system. MATERIALS AND METHODS: We conducted a 24-hour feasibility study comparing a FiASP system with full carbohydrate counting (FCC) with a FiASP-and-pramlintide system with SMA. We conducted a subsequent 12-day outpatient pilot study comparing a FiASP-and-placebo system with FCC, a FiASP-and-pramlintide system with SMA, and a FiASP-and-placebo system with SMA. Basal-bolus FiASP-and-pramlintide were delivered at a fixed ratio (1 U:10 µg). Glycaemic outcomes were measured, surveys evaluated gastrointestinal symptoms and diabetes distress, and participant interviews helped establish a preliminary coding framework to assess user experience. RESULTS: Seven participants were included in the feasibility analysis. Time spent in 3.9-10 mmol/L was similar between both interventions (81%-84%). Four participants were included in the pilot analysis. Time spent in 3.9-10 mmol/L was similar between the FiASP-and-placebo with FCC and FiASP-and-pramlintide with SMA interventions (70%), but was lower in the FiASP-and-placebo with SMA intervention (60%). Time less than 3.9 mmol/L and gastrointestinal symptoms were similar across all interventions. Emotional distress was moderate at baseline, after the FiASP-and-placebo with FCC and SMA interventions, and fell after the FiASP-and-pramlintide with SMA intervention. SMA reportedly afforded participants flexibility and reduced mealtime concerns. CONCLUSIONS: The FiASP-and-pramlintide system has the potential to substitute carbohydrate counting with SMA without degrading glucose control.

Variability in How Canadian Pediatric Weight Management Clinics Deliver Care: Evidence from the CANadian Pediatric Weight Management Registry.

Background: Clinical practice guidelines for pediatric weight management highlight the importance of family-based behavioral strategies to enhance health behaviors. Little is known, however, of how clinics implement these programs. The study objectives were to (1) describe how Canadian pediatric weight management clinics deliver care and (2) evaluate change in services over time. Methods: The CANadian Pediatric Weight management Registry (CANPWR) is a multisite prospective cohort study of participants enrolled in a Canadian pediatric weight management clinic. Clinical program characteristics (e.g., referral process, inclusion criteria, funding, program characteristics, patient interaction methods, and follow-up) were collected at the start and end of the CANPWR recruitment period (2015-2019). Results: Entrance into the nine clinics varied with limiting criteria based on geographic proximity, age, weight status, and presence of health conditions. The clinics varied in size (50-220 new patients/year). The planned length of intervention varied widely, from 10 weeks to open-ended (median 2 years). Behavior modification strategies were delivered with a mix of individual and group-based sessions and most were delivered in person, complemented by use of virtual care. Over time, more clinics saw patients under the age of 5 years and all clinics defined a program length. Conclusion: Although all clinics offered family-based behavioral weight management services, these varied considerably, especially in program entrance criteria, size of clinic, and the length of intervention. The influence of the variability in delivery of services on health outcomes will be addressed in future studies.

Fully Automated Artificial Pancreas for Adults With Type 1 Diabetes Using Multiple Hormones: Exploratory Experiments.

OBJECTIVES: A fully automated insulin-pramlintide-glucagon artificial pancreas that alleviates the burden of carbohydrate counting without degrading glycemic control was iteratively enhanced until convergence through pilot experiments on adults with type 1 diabetes. METHODS: Nine participants (age, 37±13 years; glycated hemoglobin, 7.7±0.7%) completed two 27-hour interventions: a fully automated multihormone artificial pancreas and a comparator insulin-alone artificial pancreas with carbohydrate counting. The baseline algorithm was a model-predictive controller that administered insulin and pramlintide in a fixed ratio, with boluses triggered by a glucose threshold, and administered glucagon in response to low glucose levels. RESULTS: The baseline multihormone dosing algorithm resulted in noninferior time in target range (3.9 to 10.0 mmol/L) (71%) compared with the insulin-alone arm (70%) in 2 participants, with minimal glucagon delivery. The algorithm was modified to deliver insulin and pramlintide more aggressively to increase time in range and maximize the benefits of glucagon. The modified algorithm displayed a similar time in range for the multihormone arm (79%) compared with the insulin-alone arm (83%) in 2 participants, but with undesired glycemic fluctuations. Subsequently, we reduced the glucose threshold that triggers glucagon boluses. This resulted in inferior glycemic control for the multihormone arm (81% vs 91%) in 2 participants. Thereafter, a model-based meal-detection algorithm to deliver insulin and pramlintide boluses closer to mealtimes was added and glucagon was removed. The final dual-hormone system had comparable time in range (81% vs 83%) in the last 3 participants. CONCLUSION: The final version of the fully automated system that delivered insulin and pramlintide warrants a randomized controlled trial.

Comparison of two carbohydrate intake strategies to improve glucose control during exercise in adolescents and adults with type 1 diabetes.

BACKGROUND AND AIMS: During aerobic physical activity (PA), hypoglycemia is common in people with type 1 diabetes (T1D). Few studies have compared the effectiveness of different carbohydrate (CHO) intake strategies to prevent PA-induced hypoglycemia. Our objective was to compare the efficacy of two CHO intake strategies, same total amount but different CHO intake timing, to maintain glucose levels in the target range (4.0-10.0 mmol/L) during PA in people with T1D. METHODS AND RESULTS: An open-label, randomized, crossover study in 33 participants (21 adults; 12 adolescents). Participants practiced 60 min PA sessions (ergocyle) at 60% VO2peak 3.5 h after lunch comparing an intake of 0.5 g of CHO per kg of body weight applied in a pre-PA single CHO intake (SCI) or in a distributed CHO intake (DCI) before and during PA. The percentage of time spent in glucose level target range during PA was not different between the two strategies (SCI: 75 ± 35%; DCI: 87 ± 26%; P = 0.12). Hypoglycemia (<4.0 mmol/L) occurred in 4 participants (12%) with SCI compared to 6 participants (18%) with DCI (P = 0.42). The SCI strategy led to a higher increase (P = 0.01) and variability of glucose levels (P = 0.04) compared with DCI. CONCLUSIONS: In people living with T1D, for a 60 min moderate aerobic PA in the post-absorptive condition, a 0.5 g/kg CHO intake helped most participants maintain acceptable glycemic control with both strategies. No clinically significant difference was observed between the SCI and DCI strategies. ClinicalTrials.gov Identifier: NCT03214107 (July 11, 2017).

A Meal Detection Algorithm for the Artificial Pancreas: A Randomized Controlled Clinical Trial in Adolescents With Type 1 Diabetes.

OBJECTIVE: We developed a meal detection algorithm for the artificial pancreas (AP+MDA) that detects unannounced meals and delivers automatic insulin boluses. RESEARCH DESIGN AND METHODS: We conducted a randomized crossover trial in 11 adolescents aged 12-18 years with HbA1c ≥7.5% who missed one or more boluses in the past 6 months. We compared 1) continuous subcutaneous insulin infusion (CSII), 2) artificial pancreas (AP), and 3) AP+MDA. Participants underwent three 9-h interventions involving breakfast with a bolus and lunch without a bolus. RESULTS: In AP+MDA, the meal detection time was 40.0 (interquartile range 40.0-57.5) min. Compared with CSII, AP+MDA decreased the 4-h postlunch incremental area under the curve (iAUC) from 24.1 ± 9.5 to 15.4 ± 8.0 h ⋅ mmol/L (P = 0.03). iAUC did not differ between AP+MDA and AP (19.6 ± 10.4 h ⋅ mmol/L, P = 0.21) or between AP and CSII (P = 0.33). The AP+MDA reduced time >10 mmol/L (58.0 ± 26.6%) compared with CSII (79.6 ± 27.5%, P = 0.02) and AP (74.2 ± 20.6%, P = 0.047). CONCLUSIONS: The AP+MDA improved glucose control after an unannounced meal.

Perceptions and expectations of adults with type 1 diabetes for the use of artificial pancreas systems with and without glucagon addition: Results of an online survey.

BACKGROUND AND AIMS: The first hybrid artificial pancreas (AP) systems with insulin only (mono-hormonal) have recently reached the market while next generations systems are under development including those with glucagon addition (bi-hormonal). Understanding the expectations and impressions of future potential users about AP systems is important for optimal use of this clinically effective emerging technology. METHODS AND RESULTS: An online survey about AP systems which consisted of 50 questions was addressed to people with type 1 diabetes in the province of Quebec, Canada. Surveys were completed by 123 respondents with type 1 diabetes (54% women, mean (SD) age 40.2 (14.4) y.o., diabetes duration 23.7 (14.1) years, 58% insulin pump users and 43% glucose sensor users). Of the respondents, 91% understood how AP systems work, 79% trusted them with correct insulin dosing, 73% were willing to replace their current treatment with AP and 80% expected improvement in quality of life. Anxiety about letting an algorithm control their glucose levels was expressed by 18% while the option of ignoring or modifying AP instructions was favoured by 88%. As for bi-hormonal AP systems, 83% of respondents thought they would be useful to further reduce hypoglycemic risks. CONCLUSIONS: Overall, respondents expressed positive views about AP systems use and high expectations for a better quality of life, glycemic control and hypoglycemia reduction. Data from this survey could be useful to health care professionals and developers of AP systems.