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

Sponsor
Novo Nordisk A/S
Study ID
NCT05069545
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Insulin degludec — DRUG
    Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp®
  • Fast-acting insulin aspart — DRUG
    Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp®

Study Details

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

Key Dates

Start date
Oct 11, 2021
Status verified
Dec 2025
Primary completion
Sep 10, 2024
Completion
Sep 10, 2024

Study Design

Enrollment
411 participants (actual)

Arms

  • Arm: 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

Primary Outcome Measure

Change in time in range (3.9-10 mmol/L) [ Time Frame: Baseline (Day -14 to Day 0) to End of Study (Day 280) ]

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