Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 475
- 试验地点
- 2
- 主要终点
- Time in range
研究概览
简要总结
Retrospective multicenter study analyzing data gathered from medical records and diabetes management platforms to assess the effect of using Insulin Degludec (Tresiba®) on measures of diabetes control.
People with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 will be included.
Glycemic control from 12 months before the switch to Insulin Degludec will be compared to glycemic control of the 12 months after the switch.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with T1D ≥18 years at the moment of switch to Insulin Degludec
- •Diagnosed with T1D ≥2 years before switch to Insulin Degludec
- •On basal-bolus insulin therapy with insulin pens ≥2 years before switch to Insulin Degludec
- •≥6 months use of Insulin Degludec at moment of datacollection
- •Using continuous glucose monitoring ≥2 years before switch to Insulin Degludec
排除标准
- •People with T1D <18 years at the moment of switch to Insulin Degludec
- •People without T1D or with T1D <2 years before switch to Insulin Degludec
- •Women with T1D who are pregnant or planning pregnancy during -12 and +12 months
- •Not using basal-bolus insulin therapy with insulin pens during -24 and +6 months
- •Start to use non-insulin antidiabetic agents between -12 and +12 months
- •Having received treatment with oral or injectable corticosteroids during -12 and +12 months
- •Undergoing hemodialysis, renal transplantation, or beta cell transplantation during -12 and +12 months
- •<6 months use of Insulin Degludec at moment of datacollection
- •Not using continuous glucose monitoring or <2 years before switch to Insulin Degludec
研究组 & 干预措施
Study cohort
People with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 in the two participating sensors
干预措施: Insulin Degludec (Drug)
结局指标
主要结局
Time in range
时间窗: 12 months
the change in time in range (TIR: 70-180 mg/dL, averaged per month) over 24 hours between 12 (±2) months before switch to 12 (±2) months after switch to Insulin Degludec
次要结局
- HbA1c(12 months)
- Glycemic variability(12 months)
- Time above 180 mg/dL(12 months)
- Mean glucose(12 months)
- Body mass index(12 months)
- Time below 54 mg/dL(12 months)
- Time below 70 mg/dL(12 months)
- Time in range(12 months)
- Time above 250 mg/dL(12 months)
- Insulin dose(12 months)
研究者
prof dr Pieter Gillard
Coordinating Investigator
Universitaire Ziekenhuizen KU Leuven