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临床试验/NCT03228004
NCT03228004已完成1 期

Type 1 Diabetes Data Acquisition and Transfer Adherence Study

University of Florida2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2017年7月26日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
53
试验地点
2
主要终点
Improved glycemic control

研究概览

简要总结

The purpose of this pilot study is to determine if training and support, combined with reminders to facilitate glucose data sharing with the diabetes care team in between clinic visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have HbA1c levels above target.

研究设计

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

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis with T1D at least 6 months before consent is obtained
  • Aged ≥ 2 years and ≤17 years at time of enrollment
  • Must have access to a smartphone, tablet or computer at home with wireless connectivity
  • Last HbA1c of ≥7.6% and ≤11%
  • Using fixed doses, multiple daily injections or an insulin pump as primary diabetes management regimen
  • Ability to read and speak English
  • Patient at UF Health Pediatric Diabetes Clinic

排除标准

  • Significant medical comorbidity in the child or adolescent that could, in the opinion of the PI, affect participant's capacity to complete study follow up
  • Inability to read and speak English
  • Not using insulin therapy
  • Lack of access to mobile device or computer with wireless internet connectivity
  • Unwilling or unable to use clinic's software (Glooko) to facilitate glucose data upload

研究组 & 干预措施

Intervention Group

Experimental

Participants will be provided with training on how to upload glucose data via GLOOKO and will receive reminders to upload glucose data on a biweekly basis between clinic visits.

干预措施: Glooko MeterSync (Behavioral)

结局指标

主要结局

Improved glycemic control

时间窗: 16 weeks

HbA1c

Frequency of data upload

时间窗: 16 weeks

The number of times glucose data is uploaded between clinic visits

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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