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OBJECTIVE: We aimed to evaluate the longer-term safety and efficacy of hybrid closed-loop (CL) therapy in very young children with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Following a 16-week multinational, randomized crossover trial comparing hybrid CL with sensor-augmented pump (SAP) therapy in 74 very young children aged 1–7 years with T1D, participants were invited to an extension phase using CL for a further 18 months. Outcomes were compared with the primary-phase SAP period and primary-phase CL period. RESULTS: After the primary study phase, 60 participants were eligible to enroll in the extension. Of these, 49 consented (mean ± SD age 6.6 ± 1.5 years) to continue use of CL for 18 months. Percentage time in range (TIR) 3.9–10.0 mmol/L was 8.4 percentage points (95% CI 6.7–10.1; P < 0.001) higher, while HbA1c was 0.4% ([5.0 mmol/mol], 95% CI 0.3–0.6 [3.7–6.2]; P < 0.001) lower during the CL extension phase compared with primary-phase SAP period. At 18 months, mean HbA1c was 6.7 ± 0.5% and TIR was 70 ± 7%, compared with 6.7 ± 0.5% and 71 ± 6% in the primary-phase CL period. Time in hypoglycemia (<3.9 mmol/L) was similar between CL extension phase and both primary-phase SAP (P = 0.31) and CL periods (P = 0.70). There were two severe hypoglycemia events and one other serious adverse event during the extension phase. One unexpected serious adverse device effect occurred. CONCLUSIONS: Use of the Cambridge hybrid CL system led to sustained improvements in glycemic control lasting more than 18 months in very young children with T1D. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the impact of CamAPS FX hybrid closed-loop (HCL) automated insulin delivery in very young children with type 1 diabetes (T1D) on caregivers' well-being, fear of hypoglycemia, and sleepiness.Research Design and Methods: We conducted a multinational, open-label, randomized crossover study. Children (age 1-7 years) with T1D received treatment for two 4-month periods in random order, comparing HCL with sensor augmented pump (control). At baseline and after each treatment period, caregivers were invited to complete World Health Organization-Five Well-Being Index, Hypoglycemia Fear Survey, and Epworth Sleepiness Scale questionnaires.Results: Caregivers of 74 children (mean ± SD age 5 ± 2 years and baseline HbA1c 7.3 ± 0.7%; 42% female) participated. Results revealed significantly lower scores for hypoglycemia fear (P < 0.001) and higher scores for well-being (P < 0.001) after HCL treatment. A trend toward a reduction in sleepiness score was observed (P = 0.09).Conclusions: Our results suggest better well-being and less hypoglycemia fear in caregivers of very young children with T1D on CamAPS FX HCL. [ABSTRACT FROM AUTHOR]

Objective: To investigate temporal trends in glycemic control and severe hypoglycemia rates for pediatric patients with type 1 diabetes from 1995 to 2016 by analyzing data from the longitudinal, prospective, population-based German/Austrian (Diabetes Patient History Documentation [DPV]) and Western Australian (Western Australian Children's Diabetes Database [WACDD]) diabetes registries.Research Design and Methods: Patients diagnosed with type 1 diabetes aged <15 years were identified from the DPV (N = 59,883) and WACDD (N = 2,595) registries and data extracted for all clinic visits occurring between 1995 and 2016, inclusive. Mean HbA1c and severe hypoglycemia (self-reported loss of consciousness/convulsion) rates were calculated per 100 patient-years.Results: Between 1995 and 2016, the annual mean HbA1c decreased from 8.3 to 7.8% in the DPV cohort and from 9.2 to 8.3% in the WACDD cohort. Over the same period, the severe hypoglycemia rate decreased by an annual average of 2% (relative risk 0.983 [95% CI 0.981, 0.986]) in the DPV cohort and 6% (relative risk 0.935 [95% CI 0.934, 0.937]) in the WACDD cohort. Concomitant decreasing trends in both HbA1c and severe hypoglycemia rates were observed in boys and girls, all age-groups, and injection therapy/pump regimen groups.Conclusions: Over the past two decades, there have been concurrent improvements in HbA1c and decreasing severe hypoglycemia rates in two contemporary, longitudinal, population-based pediatric cohorts of type 1 diabetes. Translation of these data into clinical practice and patient education may reduce fear of hypoglycemia and enable better glycemic control. [ABSTRACT FROM AUTHOR]

Objective: To quantify age-related variability of insulin needs during day and night closed-loop insulin delivery.Research Design and Methods: We retrospectively analyzed data from hybrid closed-loop studies involving young children (1-6 years old, n = 20), children (7-12 years, n = 21), adolescents (13-17 years, n = 15), and adults (>18 years, n = 58) with type 1 diabetes. The coefficient of variation quantified variability of insulin needs during 3 weeks of unrestricted-living hybrid closed-loop use.Results: Data from 2,365 nights and 2,367 days in 114 participants were analyzed. The coefficient of variation of insulin delivery was higher in young children compared with adults (mean difference at nighttime 10.7 percentage points [95% CI 2.9-18.4], P = 0.003; daytime 6.4 percentage points [95% CI 2.0-10.9], P = 0.002) and compared with adolescents (mean difference at nighttime 10.2 percentage points [95% CI 0.0-20.4], P = 0.049; daytime 7.0 percentage points [95% CI 1.1-12.8], P = 0.014).Conclusions: Diabetes management in young children is complicated by higher variability in insulin requirements, supporting fast-track clinical practice adoption of closed-loop in this vulnerable population. [ABSTRACT FROM AUTHOR]

Objective: Celiac disease (CD) has a recognized association with type 1 diabetes. We examined international differences in CD prevalence and clinical characteristics of youth with coexisting type 1 diabetes and CD versus type 1 diabetes only.Research Design and Methods: Data sources were as follows: the Prospective Diabetes Follow-up Registry (DPV) (Germany/Austria); the T1D Exchange Clinic Network (T1DX) (U.S.); the National Paediatric Diabetes Audit (NPDA) (U.K. [England/Wales]); and the Australasian Diabetes Data Network (ADDN) (Australia). The analysis included 52,721 youths <18 years of age with a clinic visit between April 2013 and March 2014. Multivariable linear and logistic regression models were constructed to analyze the relationship between outcomes (HbA1c, height SD score [SDS], overweight/obesity) and type 1 diabetes/CD versus type 1 diabetes, adjusting for sex, age, and diabetes duration.Results: Biopsy-confirmed CD was present in 1,835 youths (3.5%) and was diagnosed at a median age of 8.1 years (interquartile range 5.3-11.2 years). Diabetes duration at CD diagnosis was <1 year in 37% of youths, >1-2 years in 18% of youths, >3-5 years in 23% of youths, and >5 years in 17% of youths. CD prevalence ranged from 1.9% in the T1DX to 7.7% in the ADDN and was higher in girls than boys (4.3% vs. 2.7%, P < 0.001). Children with coexisting CD were younger at diabetes diagnosis compared with those with type 1 diabetes only (5.4 vs. 7.0 years of age, P < 0.001) and fewer were nonwhite (15 vs. 18%, P < 0.001). Height SDS was lower in those with CD (0.36 vs. 0.48, adjusted P < 0.001) and fewer were overweight/obese (34 vs. 37%, adjusted P < 0.001), whereas mean HbA1c values were comparable: 8.3 ± 1.5% (67 ± 17 mmol/mol) versus 8.4 ± 1.6% (68 ± 17 mmol/mol).Conclusions: CD is a common comorbidity in youth with type 1 diabetes. Differences in CD prevalence may reflect international variation in screening and diagnostic practices, and/or CD risk. Although glycemic control was not different, the lower height SDS supports close monitoring of growth and nutrition in this population. [ABSTRACT FROM AUTHOR]

The article discusses the international comparison between smoking and metabolic control in type 1 diabetes patients (T1D), which may increase the risks of vascular complication of T1D. Topics discussed include the utilization of the Wilcoxon signed-rank test, T1D Exchange Registry (T1DX) in the U.S., and the Prospective Diabetes Follow-up Registry (DPV) in Germany.