A Research Study Looking at How the Use of NovoPen® 6 for Treatment With Tresiba® & Fiasp® Affect… (NCT05069545) | Clinical Trial Compass
CompletedNot Applicable
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
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in time in range (3.9-10 mmol/L)
Timeframe: Baseline (Day -14 to Day 0) to End of Study (Day 280)