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临床试验/NCT03534544
NCT03534544已完成不适用

Patient and Parent Preferences for an On-Body Automated Insulin Delivery System

Joslin Diabetes Center2 个研究点 分布在 1 个国家目标入组 362 人开始时间: 2018年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
362
试验地点
2
主要终点
Youth and parent preferences for automated insulin delivery systems

研究概览

简要总结

The goal of this study is to learn more about patient and family preferences regarding use of advanced diabetes technologies. Young persons with type 1 diabetes (ages 8-25) and parents of young persons with type 1 diabetes will complete one study visit involving a semi-structured interview and surveys. The results of the study will be used to assist in the design of a new automated insulin delivery system.

详细描述

Type 1 diabetes remains the most common chronic disease of childhood and affects millions of children and adults globally. The minority of persons with type 1 diabetes achieve the recommended glycemic targets. Currently approved and unapproved automated insulin delivery systems require patients to carry and wear multiple devices (pumps, tubing, blood glucose meters, mobile devices, etc.). There is a need to design automated insulin delivery systems that reduce the burden of diabetes management for young persons and their families in an effort to improve glycemic control as well as other biomedical and psychosocial outcomes.

The purpose of this study is to conduct separate semi-structured interviews with young persons with type 1 diabetes and parents of youth with type 1 diabetes (not necessarily the parents of the youth participants) regarding their preferences for an automated, on-body insulin delivery system. Youth and parents will also complete short surveys related to perceived burden of diabetes self-care, quality of life, acceptance of diabetes, and worries about hypoglycemia. The feedback received from the interviews and surveys will help inform the design of a new on-body automated insulin delivery system.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
8 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Young persons (ages 8-25 years) with type 1 diabetes for 1 year or longer
  • Parents of young persons with type 1 diabetes

排除标准

  • 未提供

结局指标

主要结局

Youth and parent preferences for automated insulin delivery systems

时间窗: 1 day

Semi-structured interviews with young persons with type 1 diabetes and parents; interviews will be transcribed and analyzed to derive central themes; this is a qualitative outcome

次要结局

  • Diabetes burden(1 day)
  • Worries about hypoglycemia(1 day)
  • Diabetes acceptance(1 day)
  • Quality of life(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lori Laffel

Chief, Pediatric, Adolescent, and Young Adult Section; Co-Head, Section on Clinical, Behavioral and Outcomes Research

Joslin Diabetes Center

研究点 (2)

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