A Multi-centre Prospective Non-interventional Clinical Investigation Studying the Glycaemic Control in Patients With Type 1 Diabetes When Introducing a NovoPen® 6 for Treatment With Tresiba® (Insulin Degludec) & Fiasp® (Fast-acting Insulin Aspart) in a Real-world Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 411
- 试验地点
- 26
- 主要终点
- Change in time in range (3.9-10 mmol/L)
研究概览
简要总结
The purpose of this study is to collect information on how NovoPen® 6 works with Tresiba® & Fiasp® for treatment of people with type 1 diabetes and see if the use of NovoPen® 6 can help participants achieve better blood sugar levels.
Participants will use Tresiba® & Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor.
NovoPen® 6 is a smart pen, which collects and stores the date and time of injections and number of units of insulin participants have taken.
NovoPen® 6 can transfer participants insulin dosing information to the mobile application, which participants use to see their continuous blood sugar level. This will allow participants to see their insulin doses along with continuous blood sugar level in the mobile application.
Participants will keep using their own continuous blood sugar monitoring device and the mobile application to see these data during the study.
The study will last for about 9-11 months. Participants will be asked to complete 2 questionnaires in this study. One questionnaire is about overall satisfaction of using a digital health solution and other is about quality of life. Participants will complete these questionnaires during their normally scheduled visit with the study doctor, on 2 separate occasions
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 procedure related to recording of data according to the protocol).
- •Male or female, age above or equal to 18 years at the time of signing consent.
- •Diagnosed with T1DM (Type 1 Diabetes Mellitus) for above or equal to 1 year (365 days) at the time of signing consent.
- •On treatment with Tresiba® for more than or equal to 1 month (30 days) and Fiasp® for for more than or equal to 3 months (90 days) at the time of signing consent.
- •The decision to initiate the use of commercially available NovoPen® 6 as a part of treatment with Tresiba® and Fiasp® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
- •Current user of a rtCGM (Real-Time Continuous Glucose Monitoring) or isCGM (Intermittent-scanning Continuous Glucose Monitoring) for greather than or equal to 2 months (60 days) of which the last 14 days must be on rtCGM or isCGM, which can integrate the data with diabetes treatment support solution from either Glooko or Abbott, at the time of signing consent.
- •Willingness to continue using a rtCGM or isCGM for the duration of the study, which can integrate the data with diabetes treatment support solution from either Glooko or Abbott.
- •Current user of a diabetes treatment support solution from either Glooko or Abbott, which can integrate the NovoPen® 6 injection data and the rtCGM/isCGM data, and willingness to continue using the same solution for the duration of the study.
排除标准
- •Previous participation in this study. Participation is defined as having given 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.
- •Use of any smart pen or smart cap for the diabetes treatment prior to the signing consent.
研究组 & 干预措施
Tresiba + Fiasp using NovoPen 6 per local label
Participants will use Tresiba® and Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor
干预措施: Insulin degludec (Drug)
Tresiba + Fiasp using NovoPen 6 per local label
Participants will use Tresiba® and Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor
干预措施: Fast-acting insulin aspart (Drug)
结局指标
主要结局
Change in time in range (3.9-10 mmol/L)
时间窗: Baseline (Day -14 to Day 0) to End of Study (Day 280)
Percentage change (absolute) (Using available rtCGM (Real-Time Continuous Glucose Monitoring) and isCGM data(Intermittent-scanning Continuous Glucose Monitoring))
次要结局
- Change in time in hypoglycaemia/below range Level 2 (below 3.0 mmol/L)(Baseline (Day -14 to Day 0) to End of Study (Day 280))
- Change in mean glucose(Baseline (Day -14 to Day 0) to End of Study (Day 280))
- Change in HbA1c (Glycated haemoglobin)(Baseline (Week 0) to End of Study (Week 40))
- Change in time in hyperglycaemia/above range Level 1 (10.1 - 13.9 mmol/L)(Baseline (Day -14 to Day 0) to End of Study (Day 280))
- Change in time in hyperglycaemia/above range Level 2 (greater than 13.9 mmol/L)(Baseline (Day -14 to Day 0) to End of Study (Day 280))
- Change in time in hypoglycaemia/below range Level 1 (3.0-3.8 mmol/L)(Baseline (Day -14 to Day 0) to End of Study (Day 280))
- Change in glucose variability (% coefficient of variability)(Baseline (Day -14 to Day 0) to End of Study (Day 280))
- Change in Glucose Management Indicator(Baseline (Day -14 to Day 0) to End of Study (Day 280))
- T1-DDS (Diabetes Distress Scale for Adults with Type1 Diabetes), change in QoL (Quality of Life)(Baseline (Week 0) to End of Study (Week 40))
- DHSS (Digital Health Solution Satisfaction)-Patient(End of Study (Week 40))
- DHSS-HCP(Health Care Professional)(End of Study (Week 40))