scholarly journals Real-World Use of Do-it-Yourself Artificial Pancreas Systems in Children and Adolescents: Self-Reported Clinical Outcomes (Preprint)

2019 ◽  
Author(s):  
Katarina Braune ◽  
Shane O'Donnell ◽  
Bryan Cleal ◽  
Dana Lewis ◽  
Adrian Tappe ◽  
...  

BACKGROUND Patient-driven initiatives have made uptake of Do-it-Yourself Artificial Pancreas Systems (DIYAPS) increasingly popular amongst people with diabetes of all ages. Observational studies show improvements in glycemic control and quality of life amongst adults. However, there remains a lack of research examining experiences of children and adolescents with DIYAPS in everyday life and their social context. OBJECTIVE This study assesses self-reported clinical outcomes of the pediatric population using DIYAPS in real-world use. METHODS An online survey was distributed to caregivers, assessing HbA1c and Time in Range (TIR) before and after, and problems during DIYAPS use. RESULTS 209 caregivers from 21 countries responded. Children were 47.4% female with a median age of 10y; a mean diabetes duration of 5.1y ±3.9 and 10.3m ±10.0 experience with DIYAPS. Clinical outcomes improved significantly, including HbA1c (from 6.91% ±0.88 to 6.27% ±0.67; P<.001) and TIR (from 64.2% ±15.94 to 80.68% ±9.26; P<.001). CONCLUSIONS Improved glycemic outcomes were found across all pediatric age groups including adolescents and very young children. These findings are in line with clinical trial results from commercially developed closed-loop systems. CLINICALTRIAL The study was approved by the Charité ethics committee (EA2/140/18).

10.2196/14087 ◽  
2019 ◽  
Vol 7 (7) ◽  
pp. e14087 ◽  
Author(s):  
Katarina Braune ◽  
Shane O'Donnell ◽  
Bryan Cleal ◽  
Dana Lewis ◽  
Adrian Tappe ◽  
...  

Background Patient-driven initiatives have made uptake of Do-it-Yourself Artificial Pancreas Systems (DIYAPS) increasingly popular among people with diabetes of all ages. Observational studies have shown improvements in glycemic control and quality of life among adults with diabetes. However, there is a lack of research examining outcomes of children and adolescents with DIYAPS in everyday life and their social context. Objective This survey assesses the self-reported clinical outcomes of a pediatric population using DIYAPS in the real world. Methods An online survey was distributed to caregivers to assess the hemoglobin A1c levels and time in range (TIR) before and after DIYAPS initiation and problems during DIYAPS use. Results A total of 209 caregivers of children from 21 countries responded to the survey. Of the children, 47.4% were female, with a median age of 10 years, and 99.4% had type 1 diabetes, with a median duration of 4.3 years (SD 3.9). The median duration of DIYAPS use was 7.5 (SD 10.0) months. Clinical outcomes improved significantly, including the hemoglobin A1c levels (from 6.91% [SD 0.88%] to 6.27% [SD 0.67]; P<.001) and TIR (from 64.2% [SD 15.94] to 80.68% [SD 9.26]; P<.001). Conclusions Improved glycemic outcomes were found across all pediatric age groups, including adolescents and very young children. These findings are in line with clinical trial results from commercially developed closed-loop systems.


PEDIATRICS ◽  
1992 ◽  
Vol 89 (4) ◽  
pp. 788-790
Author(s):  

In the United States approximately 30 000 people die from firearm injuries each year. Many more are wounded. In the mid 1980s, more than 3000 of the dead were children and adolescents aged 1 to 19 years.1 In 1989 nearly 4000 firearm deaths were among children 1 to 19 years of age, accounting for 12% of all deaths in that age group.2 All of these deaths or injuries affect other children because the victims who are killed or wounded are frequently relatives, neighbors, or friends. Comparison data for childhood age groups demonstrate that in 1987, 203 children aged 1 to 9 years, 484 children aged 10 to 14 years, and 2705 adolescents aged 15 to 19 years died as a result of firearm injuries.1 Firearm deaths include unintentional injuries, homicides, and suicides. Among the 1- to 9-year-olds, half of the deaths were homicides and half were unintentional. Among the 10- to 14-year-olds, one third of the deaths were homicides, one third were suicides, and one third were unintentional. Among the 15- to 19-year-olds, 48% were homicides, 42% were suicides, and 8% were unintentional.1 Firearm homicides are the leading cause of death for some US subpopulations, such as urban black male adolescents and young adults.3 Table 1 indicates how firearms contributed to the deaths of children and adolescents (homicides, suicides, and all causes) in 1987. Table 2 illustrates the unusual scale of firearm violence affecting young people in the United States compared with other developed nations.4 Firearm injuries are the fourth leading cause of unintentional injury deaths to children younger than 15 years of age in the US.5


2010 ◽  
Vol 2 (3) ◽  
pp. 95-104
Author(s):  
Sonja Prćić ◽  
Verica Đuran ◽  
Dragan Katanić

Abstract Vitiligo is an acquired, often hereditary skin depigmentation disorder, characterized by discrete, well-circumscribed, chalk-white macules or patches. It affects all age groups, but in more than half of the patients it occurs before the age of twenty, when self-image is being formed and social acceptance is of great importance. Although similar to the disease in adults, vitiligo in children and adolescents does have differences in epidemiology, association with other endocrine and/or autoimmune disorders, and treatment. This is a review of vitiligo in the pediatric population, emphasizing key differences with vitiligo in adults. According to the literature reports, we suggest that children and adolescents with vitiligo, especially non-segmental type, should perform annual screening for thyroid dysfunction, particularly for parameters of autoimmune thyroiditis.


Author(s):  
Karina Conde ◽  
Paula Victoria Gimenez ◽  
Tomás Salomón ◽  
Raquel Inés Peltzer ◽  
Sebastián Laspiur ◽  
...  

The impact of the COVID-19 pandemic and isolation measures on alcohol consumption remains unknown among Latin-American countries. This paper characterizes differences in alcohol consumption and related problems before and after the pandemic among Argentinians from different genders, age groups, income levels, and behaviors regarding the acquisition of alcoholic beverages. Through an online survey 1446 participants were assessed regarding four alcohol consumption dimensions (frequency, quantity, heavy episodic drinking -HED- and alcohol-related problems) three months prior and after the first cases in the country and subsequent lockdown measures. Overall, participants reported small reductions for usual consumption and moderate ones for HED and related problems. As expected, very high reductions were found for those underage (14 to 18 years), and young adults (19 to 24 years). Those who had an increase in income after the pandemic did not report changes in consumption, while those whose income remained equal or lowered reported reductions. Those who did not report special behaviors to acquire alcohol (e.g. pre-stocking) informed decreases in consumption compared to those who did. This study provides new evidence on the impact of environmental factors in public health, suggesting restricted access to alcohol generates a significant decrease in alcohol consumption and related problems.


2021 ◽  
Vol 9 ◽  
Author(s):  
Sara Uccella ◽  
Elisa De Grandis ◽  
Fabrizio De Carli ◽  
Maria D'Apruzzo ◽  
Laura Siri ◽  
...  

The COVID-19 pandemic has changed individuals' lifestyles to a great extent, particularly in Italy. Although many concerns about it have been highlighted, its impact on children and adolescents has scarcely been examined. The purpose of this study was to explore behavioral consequences and coping strategies related to the pandemic among families in Italy, by focusing on developmental ages from the caregivers' perspective, 3 weeks into quarantine. An exploratory cross-sectional online survey was conducted over 14 days. Google Forms was employed to conduct the survey. Demographic variables and pre-existing Psychological Weaknesses (PsW) were asked. Adults' sleep difficulties (SleepScore) and coping strategies during quarantine were assessed. Behavioral changes related to quarantine of both subjects completing the form (COVIDStress) and their children (when present) were questioned. Of the 6,871 respondents, we selected 6,800 valid questionnaires; 3,245 declared children aged under 18 years of age (caregivers). PsWs were recognizable in 64.9% among non-caregivers and in 61.5% of caregivers, with a mean PsW score of 1.42 ± 1.26 and 1.30 ± 1.25 over 3 points, respectively. The 95.5% of the non-caregivers and the 96.5% of caregivers presented behavioral changes with a mean COVIDStress of 3.85 ± 1.82 and 4.09 ± 1.79 over 8, respectively (p&lt;0.001). Sleep difficulties were present in the 61.6% of the non-caregivers and in the 64.4% of the caregivers (p &lt; 0.001), who showed higher SleepScores (2.41 ± 1.26 against 2.57 ± 1.38 points over 6, p &lt; 0.001). COVIDStress (and SleepScore) strongly correlated with PsW (p &lt; 0.001). Caregivers observed behavioral changes in their children in the 64.3% of the &lt;6 years old and in 72.5% of 6–18 years old. Caregivers' discomfort related to quarantine (COVIDStress, SleepScore) was strongly associated to behavioral changes in both age groups of &lt;6 and 6–18 (p &lt; 0.001). Presence of caregivers' coping strategies was less associated to behavioral changes in the &lt;6 sample (p = 0.001) but not in the 6–18 (p = 0.06). The COVID-19 pandemic has adversely impacted families in Italy with regard to behavioral changes, especially in high-risk categories with PsWs and caregivers, especially the ones with children aged &lt;6 years. While coping strategies functioned as protective factors, a wide array of stress symptoms had implications for children's and adolescents' behaviors. It is recommended that public children welfare strategies be implemented, especially for higher-psychosocial-risk categories.


2019 ◽  
Vol 14 (5) ◽  
pp. 868-877 ◽  
Author(s):  
Peter Jennings ◽  
Sufyan Hussain

Application of artificial pancreas systems in type 1 diabetes (T1D) represents a change in approach to managing complex glucose and insulin dynamics using automated features with higher levels of safety, precision, and reliability than those afforded by manual adjustments. To date, limited commercial systems and more widely used open-source, hybrid closed loop, Do-It-Yourself Artificial Pancreas Systems (DIY APS) have been used in nontrial real-world management of T1D. The aims of this article are twofold. First, itsynthesizes the emerging literature on DIY APS and identifies a range of evidence including research, reviews, commentaries, and opinion pieces written by DIY APS users, healthcare professionals (HCPs), and researchers. It summarizes the emerging clinical evidence for DIY APS and provide insight into how the DIY APS movement began, has been disseminated throughout diabetes online communities, and is reshaping self-management of T1D in real-world settings. Second, the article provides commentaries that explore implications of DIY APS to healthcare practice. DIY APS are radically changing T1D management. Automating the process of frequently analyzing glucose readings and appropriately titrating insulin delivery is liberating people with T1D (PWD) from some of the demands of intensive management. Within this super-specialized area of T1D management, the expertise of DIY APS users has outstripped that of many HCPs. While educational, ethical, and legal constraints need to be resolved, HCPs still need to stay abreast of this rapidly developing area. Further research is needed to inform policy and practice relating to DIY APS. Meanwhile, HCPs continue to learn from PWD’s real-world experiences of building and using DIY APS to improve metabolic and psychological outcomes.


2017 ◽  
Vol 7 (3) ◽  
pp. e1056-e1056 ◽  
Author(s):  
E Lemonnier ◽  
N Villeneuve ◽  
S Sonie ◽  
S Serret ◽  
A Rosier ◽  
...  

Abstract In animal models of autism spectrum disorder (ASD), the NKCC1 chloride-importer inhibitor bumetanide restores physiological (Cl−)i levels, enhances GABAergic inhibition and attenuates electrical and behavioral symptoms of ASD. In an earlier phase 2 trial; bumetanide reduced the severity of ASD in children and adolescents (3–11 years old). Here we report the results of a multicenter phase 2B study primarily to assess dose/response and safety effects of bumetanide. Efficacy outcome measures included the Childhood Autism Rating Scale (CARS), the Social Responsive Scale (SRS) and the Clinical Global Impressions (CGI) Improvement scale (CGI-I). Eighty-eight patients with ASD spanning across the entire pediatric population (2–18 years old) were subdivided in four age groups and randomized to receive bumetanide (0.5, 1.0 or 2.0 mg twice daily) or placebo for 3 months. The mean CARS value was significantly improved in the completers group (P: 0.015). Also, 23 treated children had more than a six-point improvement in the CARS compared with only one placebo-treated individual. Bumetanide significantly improved CGI (P: 0.0043) and the SRS score by more than 10 points (P: 0.02). The most frequent adverse events were hypokalemia, increased urine elimination, loss of appetite, dehydration and asthenia. Hypokalemia occurred mainly at the beginning of the treatment at 1.0 and 2.0 mg twice-daily doses and improved gradually with oral potassium supplements. The frequency and incidence of adverse event were directly correlated with the dose of bumetanide. Therefore, bumetanide improves the core symptoms of ASD and presents a favorable benefit/risk ratio particularly at 1.0 mg twice daily.


2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Sebastian Unizony ◽  
Timothy J. McCulley ◽  
Robert Spiera ◽  
Jinglan Pei ◽  
Paris N. Sidiropoulos ◽  
...  

Abstract Background Placebo-controlled clinical trials have demonstrated the efficacy of tocilizumab (TCZ) for remission maintenance and glucocorticoid sparing in patients with giant cell arteritis (GCA). However, limited data exist on the effectiveness and safety of TCZ for GCA in real-world clinical practice. Methods This was a retrospective, single-center analysis of patients with GCA treated with intravenous or subcutaneous TCZ (2010–2018). Outcomes evaluated before and after TCZ initiation included occurrence of flare, time to flare, annualized flare rate, flare characteristics (i.e., polymyalgia rheumatica [PMR] symptoms, cranial manifestations), prednisone use, and safety. Flare was defined as the recurrence of unequivocal GCA manifestations requiring treatment intensification. Subgroup analyses of patients with PMR or visual manifestations at GCA diagnosis were performed. Results Sixty patients with GCA were included. The median (IQR) disease duration before and after the start of TCZ was 0.6 (0.2–1.6) and 0.5 (0.3–1.4) years, respectively. At least 1 flare was observed in 43 patients (71.7%) before and in 18 (30.0%) after TCZ initiation. Median (IQR) time to flare was 0.5 (0.3–0.7) years before TCZ treatment and 2.1 (0.6–2.6) years after TCZ initiation (HR 0.22; 95% CI 0.10–0.50; p = 0.0003). The annualized flare rate significantly decreased following TCZ use (before TCZ 1.4 [95% CI 1.0–2.1]; after TCZ 0.6 [95% CI 0.3–1.0] events/year; p < 0.001). Similar improvements were observed in patients with visual manifestations or PMR symptoms at GCA diagnosis. TCZ reduced the incidence of new visual manifestations, and no flares associated with permanent vision loss occurred while patients were receiving TCZ. Mean (SD) prednisone dose at TCZ onset and at the end of follow-up was 30 (18.3) and 5 (6.9) mg/day, respectively (p < 0.0001). After TCZ initiation, 46.6% of patients successfully discontinued prednisone. The incidence of adverse events, primarily attributed to glucocorticoids, was similar before and after TCZ initiation. Conclusions In this real-world setting, TCZ improved GCA clinical outcomes significantly and demonstrated effectiveness in the subgroups of patients with PMR symptoms and GCA-related visual manifestations at GCA diagnosis. No new cases of blindness occurred after TCZ initiation. Adverse events, many attributable to glucocorticoids, were comparable before and after TCZ treatment.


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