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NCT05069545Completed

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

Source: ClinicalTrials.gov · Last updated 31 Dec 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
411 (actual)
First submitted
24 Sept 2021
Start date
11 Oct 2021
Primary completion date
10 Sept 2024
Lead sponsor
Novo Nordisk A/S
NCT number
NCT05069545

What you commit to

  • Study type: Observational
  • Participants enrolled: 411
  • From 11 Oct 2021 to the primary completion date, 10 Sept 2024
  • 26 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Use of any smart pen or smart cap for the diabetes treatment prior to the signing consent.

Other

  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Imeldaziekenhuis - Bonheiden - Department of Endocrinology
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BonheidenBelgiumUnknown status
Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
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BrusselsBelgiumUnknown status
HUB Hôpital Erasme
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BrusselsBelgiumUnknown status
UZA - UZ Antwerpen - Department of Endocrinology
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EdegemBelgiumUnknown status
UZ Leuven - Endocrinology
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LeuvenBelgiumUnknown status
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumUnknown status
Aarhus Universitetshospital Diabetes og Hormonsygdomme
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Aarhus NDenmarkUnknown status
Bispebjerg Hospital, IC-Forskning
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CopenhagenDenmarkUnknown status
Medicinsk Afdeling B, Herning Centralsygehus
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HerningDenmarkUnknown status
Regionshospitalet Silkeborg - Endokrinologisk afd.
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SilkeborgDenmarkUnknown status
Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre
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CaenFranceUnknown status
Centre Hospitalier Sud Francilien
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Corbeil-EssonnesFranceUnknown status
Hôpital Saint Joseph Saint Luc
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LyonFranceUnknown status
Centre Hospitalier Universitaire de Montpellier-Hopital Lapeyronie
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MontpellierFranceUnknown status
Ap-Hp-Hopital Bichat-Claude Bernard-1
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ParisFranceUnknown status
Hospices Civils de Lyon-Hopital Lyon Sud-2
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Pierre-BéniteFranceUnknown status
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2
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ToulouseFranceUnknown status
Chru de Nancy-Hopital Brabois
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Vandœuvre-lès-NancyFranceUnknown status
Diabetesmottagningen, Medicinkliniken, Södra Älvsborgs Sjukhus
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BoråsSwedenUnknown status
Diabetesmottagningen, Södra Älvsborgs Sjukhus
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BoråsSwedenUnknown status
Endokrinologiska kliniken, Malmö
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MalmöSwedenUnknown status
Medicinmottagning1 Universitetssjukhuset Örebro
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ÖrebroSwedenUnknown status
Centrum for Diabetes, Academical Specialist Centrum
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StockholmSwedenUnknown status
Medicinkliniken Sundsv
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SundsvallSwedenUnknown status
Uppsala universitetssjukhus
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UppsalaSwedenUnknown status
Frölunda Specialistsjukhus
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Västra FrölundaSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.