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临床试验/NCT02155855
NCT02155855已完成不适用

Effectiveness of and Satisfaction With Remote Blood Glucose Monitoring and Telemedicine for Adolescents With Insulin-dependent Diabetes

Texas Tech University Health Sciences Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
hemoglobin A1c

研究概览

简要总结

Investigators hope that providing patients and families with additional ways of communication with the diabetes care team will improve diabetes control.

详细描述

Study Group Study group will be asked to test blood glucose at least 4 times a day Each time the study subject takes a meter reading the meter time-stamps the reading. All meter readings will upload to the cloud via" Myglucohealth" website, where they can be accessed by caregivers, including providers and parents. Device will be programmed to coax patients when readings are due. Parents will be notified by device about the blood glucose testing results. Provider will set device to alert patient or patient's family if patient has not yet tested or uploaded a test or send alerts to parent if uploaded numbers are outside an identified range (<70 mg/dL > 300 mg/dL). As per the standard of care, parents are trained to administer sugar containing liquids, or inject extra insulin for hyperglycemia correction. Parents will be encouraged to contact study personnel if they are concerned about the diabetes control. Study personnel will access home blood glucose monitor data, and provide insulin dosing advice. Parents will be asked to upload blood glucose readings prior to each visit.

Control group Subjects will continue routine care which requires blood glucose testing at least 4 times a day. Parents will use customary ways to communicate (pager, email, fax or phone) with the Diabetes team, if they are concerned about glycemic control..

Study group will have two virtual visits (months 3 and 6) Control group will have all quarterly visits in person. A laptop will be used for virtual visits and will be set up with the help of the TTUHSC Information Technology Security Officer.

研究设计

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

入排标准

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

入选标准

  • - Age 10-18 years
  • Multiple daily injections regimen
  • Duration of diabetes > 12 months
  • HbA1c > 7%
  • Lives outside of Lubbock
  • Committed to visit schedule

排除标准

  • Foster care or residential facility
  • Psychiatric illness
  • Developmental delay
  • Reading at < 4th grade level
  • Pregnancy
  • Known seizure disorder

结局指标

主要结局

hemoglobin A1c

时间窗: 12 months

As an indicator of diabetes control

次要结局

  • Frequency of contact with diabetes care team(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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