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临床试验/NCT03680079
NCT03680079已完成不适用

Group Education Program for High-risk Youth With Poorly-controlled Type 1 Diabetes

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
HbA1c

研究概览

简要总结

This study aims to implement a group education curriculum integrated with social media participation to provide peer support and interactive education sessions with the goal of improving glycemic control in disadvantaged youth with poorly-controlled type 1 diabetes.

详细描述

It has been well established through The Diabetes Control and Complications Trial (DCCT) and its follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) studies that achieving lower hemoglobin A1c (HbA1c) levels are associated with the delay and prevention of long-term complications of T1DM (1, 2). Management of T1DM involves adherence to a complex, labor-intensive regimen of subcutaneous insulin treatment, close glucose monitoring, accurate calculation of carbohydrate intake, and adjustment of dosing and dietary regimen to account for physical activity.

Recent technological advances including insulin pumps with auto-insulin-adjusting features along with continuous glucose monitoring systems have allowed for individuals with T1DM to achieve tighter diabetes control. However, despite these advances in glucose monitoring and insulin delivery systems, the majority of children and adolescents fail to optimize their diabetes control and are unable to achieve these targets.

Several studies have shown that adolescents in poor diabetes control are more likely to come from a racial minority background, have lower annual household income, and be publicly insured. In addition, these patients are also more likely to have missed medical appointments and have less stable home environments. Thus, increased efforts and innovative programs are needed to overcome additional barriers faced by youth with T1DM from disadvantaged backgrounds with the goal of improving the delivery of diabetes care for our most vulnerable, at-risk youth population.

The objective of this pilot and feasibility project is to implement a clinic-based group education program targeting teens with poorly controlled diabetes, focusing on peer group interaction and education combined with social media support to increase engagement and promote behavioral change to improve glycemic control.

This study utilizes 1) group education sessions (6 total sessions over the course of 9 months), 2) online social media group forums, 3) questionnaires to assess self-care habits in diabetes management and quality of life, and 4) surveys to assess this program.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Between ages 13-18 (at the time of consent) with diagnosis of T1DM
  • HbA1c >9% and/or episode of DKA within the past year (other than at diagnosis)
  • Residence in a zip code associated with lower socioeconomic status (SES)
  • Possession of a device capable of accessing online social media platforms
  • Exclusion criteria:
  • Non-English speaking
  • Diagnosed with a developmental or psychological condition that would prevent assumption of self-care responsibilities

排除标准

  • 未提供

研究组 & 干预措施

Youth with type 1 diabetes

Other

A group of 16 teens (ages 13-18) with poorly -controlled type 1 diabetes will be recruited to participate in this study.

干预措施: Group education sessions (Other)

结局指标

主要结局

HbA1c

时间窗: 12 months

Measure of glycemic control

次要结局

  • Depression screening(9 months)
  • Number of hospital admissions for DKA(12 months)
  • Diabetes self-management skills(9 months)
  • Improved quality of life(9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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