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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

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

NCT05069545•Novo Nordisk A/S

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (26)

Imeldaziekenhuis - Bonheiden - Department of Endocrinology

Bonheiden, Belgium

HUB - Hôpital Erasme

Brussels, Belgium

Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

Brussels, Belgium

UZA - UZ Antwerpen - Department of Endocrinology

Edegem, Belgium

UZ Leuven - Endocrinology

Leuven, Belgium

Centre Hospitalier Universitaire de Liège

Liège, Belgium

Aarhus Universitetshospital Diabetes og Hormonsygdomme

Aarhus N, Denmark

Bispebjerg Hospital, IC-Forskning

Copenhagen, Denmark

Medicinsk Afdeling B, Herning Centralsygehus

Herning, Denmark

Regionshospitalet Silkeborg - Endokrinologisk afd.

Silkeborg, Denmark

Key Dates

Start Date

October 11, 2021

Primary Completion Date

September 10, 2024

Completion Date

September 10, 2024

Last Updated

December 31, 2025

Enrollment

411

ACTUAL participants

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin degludec

DRUG

Fast-acting insulin aspart

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

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