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Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes (TransClin)

2018年11月7日 更新者:University of Western Ontario, Canada

Multicentre Randomized Controlled Trial of Structured Transition on Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes

Structured transition program for adolescents and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance as well as glycemic control after transition from pediatric to adult diabetes care.

研究概览

地位

完全的

详细说明

The purpose of this study is to determine if a structured transition program for adolescents and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance and management as well as glycemic control after transition from pediatric to adult diabetes care.

研究类型

介入性

注册 (实际的)

188

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • London、Ontario、加拿大、N6A 4V2
        • St. Joseph's Health Care
      • London、Ontario、加拿大、N6A 5W9
        • London Health Sciences Centre - Children's Hospital
      • Mississauga、Ontario、加拿大、L5B 1B8
        • Trillium Pediatric Diabetes Clinic
      • Ottawa、Ontario、加拿大、K1H 8L1
        • Children's Hospital of Eastern Ontario

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

17年 至 20年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Established T1D diagnosis for a minimum of one year (chosen to allow time for adjustment to a new diagnosis and more stable disease control).
  • Between the ages of 17 and 20 years. It is left to the clinical judgment of the pediatric endocrinologist to determine individually the appropriate age of the transition for each subject
  • At least 1 visit during the previous year with the pediatric endocrinologist at a Diabetes Clinic (aim is to minimize the non-adherence with the intervention).
  • Ability to participate in all aspects of this clinical trial.
  • Written informed consent/assent must be obtained and documented.
  • Resident of Ontario.

Exclusion Criteria:

  • Pregnant or lactating females or intent to become pregnant during the next 3 years.
  • Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.
  • Prior enrollment in the current study.
  • Current participation in another clinical trial or participation in another clinical trial in the 6 months prior to enrollment.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Transition Coordinator
A Transition Coordinator, a Certified Diabetes Educator, will provide transition support and the link between pediatric and adult diabetes care. The Transition Coordinator is central to the intervention and will provide ongoing contact with the medical system as well as education and clinical support where appropriate.
The Transition Coordinator is central to the intervention and will provide ongoing contact with the medical system as well as education and clinical support where appropriate.
无干预:Current Standard of Care
Subjects in the control group will transition to adult care equal to the intervention group and will differ only by exclusion of Transition Coordinator. Control group will receive the current standard of diabetes care otherwise unchanged. Three months following randomization, subjects in the control group will be referred to the adult endocrinologist in the same way as subjects in the intervention group

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care.
大体时间:30 months
30 months

次要结果测量

结果测量
措施说明
大体时间
In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test)
大体时间:30 months
In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test) & mean levels Frequency of retinal exam microalbumin to creatinine ratio fasting lipid profile and foot exam testing Rate of hospitalization/ER visits for acute complications of diabetes
30 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Cheril Clarson, MD、London Health Sciences Centre - Children's Hospital
  • 首席研究员:Tamara Spaic、St. Joseph's Healthcare Centre

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年4月1日

初级完成 (实际的)

2017年6月28日

研究完成 (实际的)

2017年6月30日

研究注册日期

首次提交

2011年5月10日

首先提交符合 QC 标准的

2011年5月10日

首次发布 (估计)

2011年5月11日

研究记录更新

最后更新发布 (实际的)

2018年11月9日

上次提交的符合 QC 标准的更新

2018年11月7日

最后验证

2018年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

1 型糖尿病的临床试验

Transition Coordinator的临床试验

3
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