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Protocol for a prospective, multicenter, parallel-group, open-label randomized controlled trial comparing standard care with Closed lOoP In chiLdren and yOuth with Type 1 diabetes and high-risk glycemic control: the CO-PILOT trial.一项前瞻性、多中心、平行组、开放标签随机对照试验的方案,该试验比较标准治疗与针对1型糖尿病及高风险血糖控制的儿童和青少年的闭环治疗:CO-PILOT试验。
J Diabetes Metab Disord. 2024 Mar 7;23(1):1397-1407. doi: 10.1007/s40200-024-01397-4. eCollection 2024 Jun.
2
Impact of 6-months of an advanced hybrid closed-loop system on sleep and psychosocial outcomes in youth with type 1 diabetes and their parents.6 个月的先进混合闭环系统对青少年 1 型糖尿病患者及其父母的睡眠和心理社会结果的影响。
Diabetes Res Clin Pract. 2024 Jan;207:111087. doi: 10.1016/j.diabres.2023.111087. Epub 2024 Jan 3.
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Diabetes Ther. 2024 Feb;15(2):343-365. doi: 10.1007/s13300-023-01501-6. Epub 2023 Dec 1.
4
Glucose and Psychosocial Outcomes 12 Months Following Transition from Multiple Daily Injections to Advanced Hybrid Closed Loop in Youth with Type 1 Diabetes and Suboptimal Glycemia.从多次每日注射到先进的混合闭环系统转换后 12 个月青少年 1 型糖尿病和血糖控制不佳的血糖和心理社会结果。
Diabetes Technol Ther. 2024 Jan;26(1):40-48. doi: 10.1089/dia.2023.0334. Epub 2023 Nov 7.
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Safety and Glycemic Outcomes During the MiniMed Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes.安全性和血糖控制效果:MiniMed 先进型混合闭环系统在儿童和青少年 1 型糖尿病患者中的关键性试验
Diabetes Technol Ther. 2023 Nov;25(11):755-764. doi: 10.1089/dia.2023.0255. Epub 2023 Oct 25.
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Unannounced Meal Challenges Using an Advanced Hybrid Closed-Loop System.使用高级混合闭环系统进行非预告餐食挑战。
Diabetes Technol Ther. 2023 Sep;25(9):579-588. doi: 10.1089/dia.2023.0139.
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A systematic review on the impact of commercially available hybrid closed loop systems on psychological outcomes in youths with type 1 diabetes and their parents.商业化混合闭环系统对 1 型糖尿病青少年及其父母心理结局影响的系统评价
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1型糖尿病合并高血糖的儿童和青少年实施先进的混合闭环治疗后的家长观点

Parental perspectives following the implementation of advanced hybrid closed-loop therapy in children and adolescents with type 1 diabetes and elevated glycaemia.

作者信息

Lai Sin-Ting Tiffany, Styles Sara E, Boucsein Alisa, Zhou Yongwen, Michaels Venus, Jefferies Craig, Wilshire Esko, De Bock Martin I, Wheeler Benjamin J

机构信息

Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.

Department of Human Nutrition, University of Otago, Dunedin, New Zealand.

出版信息

Diabet Med. 2025 Mar;42(3):e15448. doi: 10.1111/dme.15448. Epub 2024 Nov 25.

DOI:10.1111/dme.15448
PMID:39587412
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11823305/
Abstract

AIMS

To identify from a parental perspective facilitators and barriers of effective implementation of advanced hybrid closed-loop (AHCL) therapy in children and adolescents with type 1 diabetes (T1D) with elevated glycaemia.

METHODS

Semi-structured interviews were conducted with parents of participants while in a post-trial extension phase of the CO-PILOT randomized controlled trial. The Capability, Opportunity, Motivation, Behaviour Model and Theoretical Domain Framework informed the interviews and framework analysis.

RESULTS

Eleven parents of 9 children and adolescents were interviewed. The median age of their children and adolescents was 14.2 years (IQR 13.3-14.7) with median HbA1c 78 mmol/mol (IQR 75-86) (9.3% IQR 9-10) before starting AHCL. Facilitators of implementing AHCL therapy included the following: (1) knowledge acquired from training, (2) establishing routines and action plans, (3) remote glucose monitoring, (4) achievement of glycaemic goals through automation, (5) children/adolescents' capability to use AHCL independently, (6) improved outcomes incentivized continued AHCL, (7) optimism about sustained improvements and (8) social support from healthcare providers, school staff, peers and parents. Barriers to AHCL implementation included the following: (1) challenges with device usability, (2) need for technical support, (3) forgotten knowledge and skills, (4) non-adherence to best practices, (5) negative social influences, (6) physical and psychosocial burden and (7) negative emotions.

CONCLUSIONS

This study provides comprehensive insights into parental perspectives of influences on implementing AHCL therapy in children and adolescents with elevated glycaemia. As parents remain key partners in diabetes care, these findings inform successful implementation of AHCL and development of future diabetes technology.

摘要

目的

从家长的角度确定在血糖升高的1型糖尿病(T1D)儿童和青少年中有效实施先进混合闭环(AHCL)治疗的促进因素和障碍。

方法

在CO-PILOT随机对照试验的试验后延长期,对参与者的家长进行了半结构化访谈。访谈和框架分析采用了能力、机会、动机、行为模型和理论领域框架。

结果

对9名儿童和青少年的11名家长进行了访谈。他们的孩子和青少年的中位年龄为14.2岁(四分位间距13.3 - 14.7),开始AHCL治疗前HbA1c的中位值为78 mmol/mol(四分位间距75 - 86)(9.3%,四分位间距9 - 10)。实施AHCL治疗的促进因素包括:(1)从培训中获得的知识;(2)建立常规和行动计划;(3)远程血糖监测;(4)通过自动化实现血糖目标;(5)儿童/青少年独立使用AHCL的能力;(6)改善的结果激励持续使用AHCL;(7)对持续改善的乐观态度;(8)来自医疗保健提供者、学校工作人员、同伴和家长的社会支持。AHCL实施的障碍包括:(1)设备可用性方面的挑战;(2)对技术支持的需求;(3)遗忘的知识和技能;(4)不遵守最佳实践;(5)负面的社会影响;(6)身体和心理社会负担;(7)负面情绪。

结论

本研究全面深入地了解了家长对血糖升高的儿童和青少年实施AHCL治疗的影响的看法。由于家长仍然是糖尿病护理的关键伙伴,这些发现为AHCL的成功实施和未来糖尿病技术的发展提供了参考。