The Effect of Fiasp® (Fast-acting Insulin Aspart) in Type 1 Diabetes Patients Using Continuous Glucose Monitoring / Flash Glucose Monitoring in Real-world Clinical Practice in Sweden. A Non-interventional, Retrospective Chart and Database Review Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Change in percentage of time spent in glycaemic target range (TIR)
研究概览
简要总结
Fiasp® is a meal-time insulin that has been available in Sweden since June 2017. This study will investigate the effectiveness of Fiasp® in treating Type 1 Diabetes Mellitus. The study will be based on blood sugar measurements that the participants have uploaded to the Diasend® database and on existing data in their electronic medical records. The study does not require any additional visits to the study doctor.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fiasp®
Participants with type 1 diabetes who have switched to a basal-bolus insulin regimen with Fiasp® as the bolus insulin, from a basal-bolus insulin regimen with any other bolus insulin.
干预措施: Fiasp® (Drug)
结局指标
主要结局
Change in percentage of time spent in glycaemic target range (TIR)
时间窗: Two-week period closest to and before index date, Two-week period closest to Week 26
Measured in percentage point. The change in percentage of TIR was defined as a blood glucose level of 3.9 to 10.0 mmol/L after initiation of Fiasp® treatment. Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018. Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
次要结局
- Change in glycaemic variability (GV) (measured as coefficient of variation [CV])(Two-week period closest to and before index date, Two-week period closest to Week 26)
- Proportion with CV lesser than 36%(Two-week period closest to Week 26)
- Change in Glycated Haemoglobin A1c (HbA1c)(Latest measurement between Week -12 and index date, measurement closest to Week 26)
- Change in mean sensor glucose(Two-week period closest to and before index date, Two-week period closest to Week 26)
- Change in percentage of time spent in level 1 hyperglycaemia (greater than 10.0 mmol/L)(Two-week period closest to and before index date, Two-week period closest to Week 26)
- Change in percentage of time spent in level 2 hyperglycaemia (greater than 13.9 mmol/L)(Two-week period closest to and before index date, Two-week period closest to Week 26)
- Change in percentage of time spent in level 2 hypoglycaemia (lesser than 3.0 mmol/L)(Two-week period closest to and before index date, Two-week period closest to Week 26)
- Change in percentage of time spent in level 1 hypoglycaemia (lesser than 3.9 mmol/L)(Two-week period closest to and before index date, Two-week period closest to Week 26)