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临床试验/NCT02568501
NCT02568501已完成3 期

Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
90
试验地点
2
主要终点
Change in HbA1c by 3 months

研究概览

简要总结

In this study the investigators will compare a novel approach using daily financial incentives and a tiered sponsor network to motivate adolescents and young adults with type 1 diabetes to improve glycemic control.

详细描述

Participants will be given daily glucose monitoring goals of ≥4 glucose checks per day with ≥1 readings within goal range (70-180 mg/dL) and provided with iHealth wireless glucometers. Half of the study participants will be randomized to the 3-month intervention arm on Way to Health. The intervention includes daily financial incentives ($60 in an account at beginning of each month with $2 daily loss if non-adherent) and a 2-level tiered sponsor network (youth select 2 people who will be notified of non-adherence after 2 and 5 consecutive days). The primary outcome will be HbA1c at 3 months compared to baseline. Secondary outcomes will include HbA1c at 6 months and the proportion of participants adherent to daily glucose monitoring goals. Exit interviews will elicit intervention feasibility and feedback from a youth perspective.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
14 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of type 1 diabetes
  • HbA1c of 8 or greater
  • Receiving care from the Childrens Hospital of Philadelphia Diabetes Center
  • English-speaking
  • Owns a smartphone

排除标准

  • New diagnosis of type 1 diabetes within past year
  • Unable to provide informed consent
  • Already participating in another study to improve glycemic control
  • Any medical conditions that would prevent completion of the study

结局指标

主要结局

Change in HbA1c by 3 months

时间窗: 3 months

Change in HbA1c from baseline to 3 months

次要结局

  • Glucose Monitoring Adherence by 6 months(6 months)
  • Change in HbA1c by 6 months(6 months)
  • Glucose Monitoring Adherence by 3 months(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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