跳至主要内容
临床试验/NCT03047486
NCT03047486已完成不适用

Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年2月1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
30
试验地点
1
主要终点
Glucose TIR (time in range) from CGM recording

研究概览

简要总结

The reference treatment of the type 1 diabetes is intensified insulin therapy by insulin pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which allows the continuous measure of interstitial glucose rate. The results are available in real time to the user, who can so use them to optimize the adjustment of its treatment by insulin pump. Since a few years, several research programs aim for finalizing an automated system using the data of real time interstitial glucose to adjust automatically, via an algorithm, the release of insulin by the pump. This type of closed-loop system is for the moment only experimental, not still widely available in routine. On the other hand, rudimentary regulation systems partially automated already exist and can be used in common clinical practice. One of these systems, Smartguard ®, allows this type of regulation to decrease the hypoglycemic risk of the patients treated by insulin pump. It is indeed a hypo minimizer which interrupts the basal output when the algorithm embarked on the pump determines thanks to the CGM data what a hypoglycemia risks to occur in the 30 minutes. The efficiency of this system to reduce hypoglycemias was proved by several studies in pediatric and adult populations of subjects with DT1 (Diabetes Care on 2015; 38:1197-1204. J Diabetes Sci Technol. 2016 May 20. Pii: 1932296816645119). However, to date, there are no published data concerning the method of use of this system (sensor et pump initial configuration; patient education), nor the evolution of the sensor and pump parameters during the use.

The aim of this observationnelle study is to collect the data of efficiency, safety and use of the system Smartguard ® in common clinical practice in an adult population of subjects DT1.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Type 1 diabetes ≥ 1 year
  • CSII ≥ 6 months
  • Previous education to flexible insulin therapy
  • Patient willing to use sensors and smartguard option for 1 year
  • A1c ≥ 7.5% and/or severe hypoglycemia ≥ 2 episodes during the last 6 month and/or recurrent hypoglycemia and/or hypoglycemia unawareness and/or brittle diabetes

排除标准

  • No access to a computer and/or to the web making it impossible to follow patients through telemedicine

结局指标

主要结局

Glucose TIR (time in range) from CGM recording

时间窗: change between baseline and after 12 month

TIR will be calculated from the CGM recording, thanks to the medtronic carelink software

Glucose Time below range (hypoglycemia < 70 mg/dl) from CGM recording

时间窗: change between baseline and after 12 month

Time below range will be calculated from the CGM recording, thanks to the medtronic carelink software

次要结局

  • HbA1c(month 0, 3, 6, 9, 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验