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临床试验/DRKS00016170
DRKS00016170已完成未知

Digital Diabetes Clinic - DDC

Charité - Universitätsmedizin Berlin0 个研究点目标入组 52 人开始时间: 2019年10月7日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
52

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
3 Years 至 18 Years(—)
性别
All

入选标准

  • Female and male children aged 3 to 12 years who have been diagnosed with T1D (type 1 diabetes mellitus; Global International Diabetes Federation/International Society for Pediatric and Adolescent Diabetes, IDF-ISPAD 2011; IDF Criteria) will be included.
  • The treatment of T1D at the time of randomization has to include:
  • o Use of daily insulin therapy (MDI, multiple daily injections; or CSII, continuous subcutaneous insulin infusion) for >6 months
  • o Use of a Dexcom G6 glucose monitoring sensor measuring interstitial glucose levels (CGM, continuous glucose monitoring) for >1 month and the intention to continuously use a Dexcom sensor for the duration of the study
  • The subject has to live with a parent/caregiver as a care partner operating the DDC study system.
  • The subject and parent/caregiver are willing to allow the respective diabetes team to receive and view therapy data transmitted by upload therapy data regularly via their client during the intervention phase.
  • The subject and parent/carer are willing to keep a digital diabetes logbook during the intervention phase.
  • Since 2020, children and adolescents aged 12 years and above and adults can enroll in the study as well.

排除标准

  • The subject is excluded if subject or parent/caregiver operating with the study system are diagnosed with a medical and/or psychiatric condition considered to interfere with ability to complete the study protocol.
  • The subject and parent/caregiver have a known cellular and/or WiFi connectivity problem at their home considered to interfere with the ability to complete the study protocol.

研究者

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