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临床试验/NCT05095610
NCT05095610已完成不适用

Clinical Effects of Intermitent Continuous Glucose Monitoring (Flash) in Adult Patients With Type 1 Diabetes in an Spanish Public Health System

Castilla-La Mancha Health Service8 个研究点 分布在 1 个国家目标入组 1,121 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,121
试验地点
8
主要终点
HbA1c difference

研究概览

简要总结

Observational cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system.

详细描述

Observational cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system.

All clinical variables are gathered from chart review. Data analysis is conducted using SPSS statistic software. Results are presented as mean +/- SD values. A paired Student´s t-test or Wilconxon signed test were used fr the analysis differences. Comparison between proportions were analyzed using a chi-square test. A P value <0.05 was considered statistically significant.

The protocolo was apporved by the reference Castilla-La Mancha Public Health Service Ethic Commitee. All participants provided written consent.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
16 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of Type 1 diabetes.
  • Age >18 years.
  • Patients previously followed in the DIACAM study.

排除标准

  • Any other kinds of diabetes.

结局指标

主要结局

HbA1c difference

时间窗: 1 year

Difference in HbA1c before initiating iCGM compared with HbA1c levels after one year of treatment.

次要结局

  • Insulin dose(1 year)
  • TBR(1 year)
  • TAR(1 year)
  • %CV(1 year)
  • Body weight(1 year)
  • Frequency of SBGM(1 year)
  • TIR(1 year)
  • Adherence to Flash(1 year)

研究者

发起方
Castilla-La Mancha Health Service
申办方类型
Other
责任方
Sponsor

研究点 (8)

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