NCT07160816进行中（未招募）不适用
A Real-world, Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control, Treatment Satisfaction and Adherence Associated With the Use of Insulin Icodec in People Living With Type 1 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 245
- 试验地点
- 51
- 主要终点
- Change in glycated haemoglobin (HbA1c)
研究概览
简要总结
The study will look at how well insulin icodec controls blood sugar levels in participants who have never used it before. Participants with type 1 diabetes (T1D) will be treated with insulin icodec as prescribed to by their doctor, in accordance with usual clinical practice. This study will last for about 22 to 30 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Signed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to the protocol).
- •The decision to initiate treatment with commercially available insulin icodec has been made by the participant/legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.
- •Male or female, age greater than or equal to (≥) 18 years at the time of signing informed consent.
- •Diagnosed with T1D ≥ 1 year before signing informed consent.
- •Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before signing informed consent.
- •Available HbA1c value less than or equal to (≤) 90 days prior to the 'Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Initiation visit' (V1) if in line with local clinical practice.
- •Treatment naïve to once-weekly insulin prior to the 'Initiation Visit' (V1).
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Treatment with any investigational drug within 30 days prior to enrolment into the study.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
研究组 & 干预措施
Insulin icodec
Participants with T1D will be treated with commercially available insulin icodec according to routine clinical practice at the discretion of the treating physician.
干预措施: Insulin icodec (Drug)
结局指标
主要结局
Change in glycated haemoglobin (HbA1c)
时间窗: Baseline (week 0), week 26
Measured as percentage (%) point of HbA1c.
次要结局
- Change in Insulin Treatment Satisfaction Questionnaire (ITSQ) score(Baseline (week 0), end of study (week 22-30))
- Change in Adelphi Adherence Questionnaire (ADAQ) score(Baseline (week 0), end of study (week 22-30))
- Number of self-reported overall severe hypoglycaemia(From baseline (week 0) to end of study (week 22-30))
- Clinical success as perceived by the physician(From baseline (week 0) to end of study (week 22-30))
研究者
研究点 (51)
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