A Research Study Looking at How the Use of NovoPen® 6 for Treatment With Tresiba® & Fiasp® Affects the Blood Sugar Level in Patients With Type 1 Diabetes as Part of Local Clinical Practice

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Insulin degludec
* Drug: Fast-acting insulin aspart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tresiba + Fiasp using NovoPen 6 per local label<br>Participants will use Tresiba® and Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor | Drug: Insulin degludec<br>* Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp®<br>Drug: Fast-acting insulin aspart<br>* Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in time in range (3.9-10 mmol/L) | Percentage change (absolute) (Using available rtCGM (Real-Time Continuous Glucose Monitoring) and isCGM data(Intermittent-scanning Continuous Glucose Monitoring)) | Baseline (Day -14 to Day 0) to End of Study (Day 280) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in time in hyperglycaemia/above range Level 1 (10.1 - 13.9 mmol/L) | Percentage change (absolute) (Using available rtCGM and isCGM data) | 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) | Percentage change (absolute) (Using available rtCGM and isCGM data) | 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) | Percentage change (absolute) (Using available rtCGM and isCGM data) | Baseline (Day -14 to Day 0) to End of Study (Day 280) | 
| Change in time in hypoglycaemia/below range Level 2 (below 3.0 mmol/L) | Percentage change (absolute) (Using available rtCGM and isCGM data) | Baseline (Day -14 to Day 0) to End of Study (Day 280) | 
| Change in mean glucose | mmol/L (Using available rtCGM and isCGM data) | Baseline (Day -14 to Day 0) to End of Study (Day 280) | 
| Change in glucose variability (% coefficient of variability) | Percentage change (absolute) (Using available rtCGM and isCGM data) | Baseline (Day -14 to Day 0) to End of Study (Day 280) | 
| Change in Glucose Management Indicator | Percentage change (absolute) (Using available rtCGM and isCGM data) (4The GMI is calculated from mean glucose as GMI (%) = 3.31 + 0.4306 [mean glucose mmol/L]) | Baseline (Day -14 to Day 0) to End of Study (Day 280) | 
| Change in HbA1c (Glycated haemoglobin) | Percentage change (absolute) (Using HbA1c results based on blood tests) | Baseline (Week 0) to End of Study (Week 40) | 
| T1-DDS (Diabetes Distress Scale for Adults with Type1 Diabetes), change in QoL (Quality of Life) | Change (absolute) (Using T1-DDS questionnaire data) | Baseline (Week 0) to End of Study (Week 40) | 
| DHSS (Digital Health Solution Satisfaction)-Patient | Total score (Using DHSS questionnaire for patient & HCP respectively) | End of Study (Week 40) | 
| DHSS-HCP(Health Care Professional) | Total score (Using DHSS questionnaire for patient & HCP respectively) | End of Study (Week 40) |