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临床试验/NCT04051632
NCT04051632已完成不适用

Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2018年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
Successful implementation of hybrid closed loop technology

研究概览

简要总结

Observational study of patients at Boston Childrens Hospital with type 1 diabetes (T1D) who elected to treat their diabetes with the Medtronic 670 G hybrid closed loop insulin pump.

详细描述

Outcome study of 90-100 patients with type 1 diabetes who elected to use the Medtronic 670G.

Major outcome measure was to assess the percent of patients who were able to successfully continue to use the 670G technology over time.

Additional outcome variables included hemoglobin A1c pre and post treatment with the 670G, time in desired glucose range 70-180.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
5 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of T1D
  • patient of Boston Childrens Hospital diabetes program
  • deemed to be adequate candidates for hybrid closed loop technology by their diabetes health care team
  • patient received Medtronic 670G training at Boston Childrens Hospital
  • patient received follow up diabetes care at Boston Childrens Hospital for at least 3 months after starting on the 670G

排除标准

  • patients not trained at Boston Childrens Hospital or self started

结局指标

主要结局

Successful implementation of hybrid closed loop technology

时间窗: 0-24 months

Percent of Type 1 Diabetes patients who were properly trained on the use of the 670G that continue to use Hybrid Closed Loop technology at 0, 6, 12, 18 and 24 months post training.

次要结局

  • Impact of hybrid closed loop technology on glycemic control(0-24 months)
  • Assess impact of hybrid closed loop technology on glycemic control by analysis of sensor glucose data.(0-24 months.)

研究者

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

Gregory Goodwin

Senior Associate Physician in Medicine

Boston Children's Hospital

研究点 (1)

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