Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Discontinuation rate differences
研究概览
简要总结
Background: The use of insulin pumps in pediatric patients with type 1 diabetes(T1D) has expanded, with lack of data comparing between the different devices.
Objective: to compare prospectively glycemic control, technical difficulties and quality of life (QOL) between 3 pump devices during the first year of use .
Methods: a prospective observational trial, based on clinical data retrieved during 12 months of follow- up. Inclusion criteria included T1D patients, ages 1-18 years, who started pump therapy as part of their clinical care in 4 university affiliated medical centers. The devices fully reimbursed by national health insurance are: MiniMed™ 640G , MiniMed® Veo™, Animas® Vibe®, and Abbott Omnipod®. Comparison parameters included quality of life (QOL), frequency of technical difficulties, skin reactions, discontinuation rate, glycated hemoglobin (HBA1C), mean glucose, total daily insulin dose (TDD) , pump setting parameters and BMI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T1D recorded by a pediatric endocrinologist
- •Attending periodic clinic visits, and starting pump mode of therapy between May 2015 and March 2017.
排除标准
- •No restrictions on HbA1c value at study recruitment or on use of CGMS -
结局指标
主要结局
Discontinuation rate differences
时间窗: 2 years from patient first enrollment
Comparison between constant pump users and those who discontinued
Technical difficulties differences
时间窗: 2 years from patient first enrollment
All patients were asked 5 questions regarding monthly frequency of technical problems including the need to use extra sets and the level of pain at catheter insertion
Quality Of Life (QOL)
时间窗: 2 years from patient first enrollment
QOL assessment was performed utilizing The Diabetes Treatment Satisfaction Questionnaires (DTSQ) for teens and for parents, separately \[14\]. The teens DTSQ contained 12 items scores on six-point scales, of which 9 were summed, the parents DTSQ contained 14 items, of which 9 were summed. Maximal grade was 42.
Skin reactions differences
时间窗: 2 years from patient first enrollment
skin assessment at the pump insertion site (itching and redness).
次要结局
- Glycemic control and metabolic parameters differences: HbA1c%(2 years from patient first enrollment)
- Glycemic control and metabolic parameters differences:Number of SMBG per day(2 years from patient first enrollment)
- Glycemic control and metabolic parameters differences:BMI SDS(2 years from patient first enrollment)
- Glycemic control and metabolic parameters differences: Insulin TDD(2 years from patient first enrollment)
- Glycemic control and metabolic parameters differences:Glucose Mean & SD(2 years from patient first enrollment)