The Impact of Different CSII and CGM Systems on Metabolic Control and Quality of Life in Children and Adolescents With Type 1 Diabetes. An Observational Study Form the Norwegian Childhood Diabetes Registry (NCDR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,749
- 主要终点
- HbA1c
研究概览
简要总结
To examine the effect of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) on metabolic control, in a large population-based nationwide observational study under real life conditions.
All children and adolescents with type 1 diabetes are investigated,using annual data in 2017 from the population-based Norwegian Childhood Diabetes Registry (NCDR). HbA1c, incidence of diabetes ketoacidosis (DKA) and severe hypoglycemia (SH) are evaluated depending on the use of CSII and CGM in a linear mixed-effects and linear regression model adjusted for age, biologic gender and diabetes duration. Health-related quality of Life (HRQOL) is assessed by using the DISABKIDS diabetes specific module (DDM-10), and associations with the use of CSII, CGM, age, gender and diabetes duration are evaluated.
详细描述
In Norway, all children with diabetes 0-18 years should, due to a recommendation from the national health care authority, receive their diabetes follow-up in a pediatric department. All pediatric departments participate in the NCDR reporting standardized clinical data on their patients to the NCDR, at diabetes onset and annually, until the patients reach 18 years of age. The data completeness of NCDR is high, on individual level 99 % at diabetes onset, and 98 % on the annual examinations in 2016 - 2017.
In addition, HRQOL data were collected in 2017, using the DISABKIDS diabetes specific module (DDM-10). Children 10-17 years with type 1 diabetes were invited to independently fill out the questionnaire regarding their own disease-related quality of life. All parents to children with type 1 diabetes (independent of the child's age) were invited to fill out the same questionnaire, giving a proxy evaluation of their child's quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All registered subjects with type 1 diabetes in the 2017 annual cohort of the NCDR
排除标准
- 未提供
结局指标
主要结局
HbA1c
时间窗: measured at annual follow-up in 2017
DKA
时间窗: registered at annual follow-up in 2017
diabetic ketoacidosis leading to hospitalization
SH
时间窗: registered at annual follow-up in 2017
Severe hypoglycemia
HRQOL
时间窗: participation connected to annual follow-up in 2017
health-related quality of life measured with the DISABKIDS diabetes module DDM-10
次要结局
未报告次要终点