MedTrace Logo

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

NCT05069545 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 411

Last updated 2025-12-31

No results posted yet for this study

Summary

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

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Insulin degludec

Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp®

DRUG

Fast-acting insulin aspart

Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp®

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 1452) · Novo Nordisk A/S

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2024-09-10
Completion
2024-09-10

Countries

  • Belgium
  • Denmark
  • France
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05069545 on ClinicalTrials.gov