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临床试验/NCT03297762
NCT03297762终止不适用

Improving Adherence to Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes

Stanford University1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2018年5月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
1
主要终点
CGM use

研究概览

简要总结

To use an enhanced continuous glucose monitor (CGM) experience, including an automated CGM-electronic health record (EHR) data integration system, proactive interventions, and gamification techniques, to increase CGM use among publicly-insured youth with type 1 diabetes (T1D).

详细描述

The investigators will use an automated data integration system to monitor hours per week the CGM is worn and target interventions/troubleshooting techniques as needed. The investigators will use gamification techniques (i.e. ability to gain points and achieve small rewards) to help encourage CGM use and potentially improve glycemic control in this at-risk population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •type 1 diabetes for more than 6 months
  • •on insulin pump or multiple daily injections without plans to change modality in next 6 months
  • •insured by CCS or Medi-Cal
  • •receiving care at Lucile Packard Children's Hospital or Stanford Children's Health outpatient clinics
  • •English or Spanish-speaking

排除标准

  • •major illness or condition that may alter glucose control or ability to complete the study including pregnancy, cystic fibrosis, cancer, liver disease, history of transplant, or hemoglobinopathy
  • •current oral glucocorticoid use
  • •prior use of a CGM system
  • •hemoglobin A1C <7.5% or >12%
  • •no wireless internet access

研究组 & 干预措施

Gamification

Experimental

Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use.

干预措施: gamification (Behavioral)

Gamification

Experimental

Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use.

干预措施: Use of Dexcom G5 (Behavioral)

Standard care

Active Comparator

Use of continuous glucose monitor (Dexcom G5) per usual care.

干预措施: Use of Dexcom G5 (Behavioral)

结局指标

主要结局

CGM use

时间窗: baseline to 6 months

amount of time per week CGM is used

次要结局

  • Hgb A1c(baseline to 6 months)

研究者

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

Darrell M Wilson

Professor of Pediatrics

Stanford University

研究点 (1)

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