Psychosocial Outcomes with the Omnipod® 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers

IF 3.9 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Pediatric Diabetes Pub Date : 2023-06-29 DOI:10.1155/2023/8867625

K. Hood, W. Polonsky, S. Macleish, C. Levy, G. Forlenza, A. Criego, B. Buckingham, B. Bode, David W. Hansen, J. Sherr, Sue A Brown, D. DeSalvo, S. Mehta, L. Laffel, A. Bhargava, Lauren M. Huyett, T. Vienneau, T. Ly

{"title":"Psychosocial Outcomes with the Omnipod® 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers","authors":"K. Hood, W. Polonsky, S. Macleish, C. Levy, G. Forlenza, A. Criego, B. Buckingham, B. Bode, David W. Hansen, J. Sherr, Sue A Brown, D. DeSalvo, S. Mehta, L. Laffel, A. Bhargava, Lauren M. Huyett, T. Vienneau, T. Ly","doi":"10.1155/2023/8867625","DOIUrl":null,"url":null,"abstract":"Objective. While automated insulin delivery (AID) systems aim to improve glycemic outcomes, the opportunity to improve psychosocial outcomes is also of critical importance for children and adolescents with type 1 diabetes and their caregivers. We evaluated psychosocial outcomes in these groups during a clinical trial of a tubeless AID system, the Omnipod® 5 Automated Insulin Delivery System. Methods. This single-arm, multicenter, prospective study enrolled 83 children (6.0–11.9 years) and 42 adolescents (12.0–17.9 years) with type 1 diabetes to use a tubeless AID system for 3 months. Participants and their caregivers completed age- and role-appropriate validated questionnaires to assess changes in psychosocial outcomes—diabetes distress (PAID), hypoglycemia confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), and system usability (SUS)—before and after 3 months of AID system use. Associations between participant characteristics and glycemic outcomes with psychosocial measures were evaluated using linear regression analyses. Results. Improvements were found for children, adolescents, and/or their caregivers for diabetes-related distress, insulin delivery satisfaction, and system usability (all \n \n P\n <\n 0.05\n \n ). Caregivers of children saw additional benefits of improved general well-being, confidence in managing hypoglycemia, and sleep quality (all \n \n P\n <\n 0.05\n \n ). Regression analyses showed that improvements in psychosocial outcomes were generally independent of baseline characteristics and changes in glycemic outcomes. Conclusions. The tubeless AID system was associated with significant improvements in a number of psychosocial outcomes for children, adolescents, and their caregivers. Trial registration: This trial is registered with NCT04196140.","PeriodicalId":19797,"journal":{"name":"Pediatric Diabetes","volume":" ","pages":""},"PeriodicalIF":3.9000,"publicationDate":"2023-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Diabetes","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1155/2023/8867625","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}

引用次数: 1

Abstract

Objective. While automated insulin delivery (AID) systems aim to improve glycemic outcomes, the opportunity to improve psychosocial outcomes is also of critical importance for children and adolescents with type 1 diabetes and their caregivers. We evaluated psychosocial outcomes in these groups during a clinical trial of a tubeless AID system, the Omnipod® 5 Automated Insulin Delivery System. Methods. This single-arm, multicenter, prospective study enrolled 83 children (6.0–11.9 years) and 42 adolescents (12.0–17.9 years) with type 1 diabetes to use a tubeless AID system for 3 months. Participants and their caregivers completed age- and role-appropriate validated questionnaires to assess changes in psychosocial outcomes—diabetes distress (PAID), hypoglycemia confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), and system usability (SUS)—before and after 3 months of AID system use. Associations between participant characteristics and glycemic outcomes with psychosocial measures were evaluated using linear regression analyses. Results. Improvements were found for children, adolescents, and/or their caregivers for diabetes-related distress, insulin delivery satisfaction, and system usability (all P < 0.05 ). Caregivers of children saw additional benefits of improved general well-being, confidence in managing hypoglycemia, and sleep quality (all P < 0.05 ). Regression analyses showed that improvements in psychosocial outcomes were generally independent of baseline characteristics and changes in glycemic outcomes. Conclusions. The tubeless AID system was associated with significant improvements in a number of psychosocial outcomes for children, adolescents, and their caregivers. Trial registration: This trial is registered with NCT04196140.

查看原文本刊更多论文

Omnipod®5自动胰岛素输送系统对1型糖尿病儿童和青少年及其护理人员的心理社会结果

客观的虽然自动胰岛素输送（AID）系统旨在改善血糖结果，但改善心理社会结果的机会对患有1型糖尿病的儿童和青少年及其护理人员也至关重要。我们在无管AID系统Omnipod®5自动胰岛素输送系统的临床试验中评估了这些组的心理社会结果。方法。这项单臂、多中心、前瞻性研究招募了83名儿童（6.0-11.9 年龄）和42名青少年（12.0–17.9 年）使用无管AID系统治疗3 月。参与者及其护理人员在3岁之前和之后完成了年龄和角色适当的验证问卷，以评估心理社会结果的变化——糖尿病痛苦（PAID）、低血糖信心（HCS）、幸福感（WHO-5）、睡眠质量（PSQI）、胰岛素输送满意度（IDSS）和系统可用性（SUS） AID系统使用数月。使用线性回归分析评估参与者特征和血糖结果与心理社会测量之间的相关性。后果儿童、青少年和/或他们的照顾者在糖尿病相关的痛苦、胰岛素输送满意度和系统可用性方面都有所改善（均P<0.05）。儿童护理人员看到了改善总体健康、管理低血糖的信心和睡眠质量的额外好处（均P<0.05）。回归分析表明，心理社会结果的改善通常与基线特征和血糖结果的变化无关。结论。无管AID系统与儿童、青少年及其照顾者的许多心理社会结果的显著改善有关。试验注册：本试验注册于NCT04196140。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Pediatric Diabetes 医学-内分泌学与代谢

CiteScore

6.60

自引率

14.70%

发文量

141

审稿时长

4-8 weeks

期刊介绍： Pediatric Diabetes is a bi-monthly journal devoted to disseminating new knowledge relating to the epidemiology, etiology, pathogenesis, management, complications and prevention of diabetes in childhood and adolescence. The aim of the journal is to become the leading vehicle for international dissemination of research and practice relating to diabetes in youth. Papers are considered for publication based on the rigor of scientific approach, novelty, and importance for understanding mechanisms involved in the epidemiology and etiology of this disease, especially its molecular, biochemical and physiological aspects. Work relating to the clinical presentation, course, management and outcome of diabetes, including its physical and emotional sequelae, is considered. In vitro studies using animal or human tissues, whole animal and clinical studies in humans are also considered. The journal reviews full-length papers, preliminary communications with important new information, clinical reports, and reviews of major topics. Invited editorials, commentaries, and perspectives are a regular feature. The editors, based in the USA, Europe, and Australasia, maintain regular communications to assure rapid turnaround time of submitted manuscripts.