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
NCT ID: NCT05069545
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
411 participants
OBSERVATIONAL
2021-10-11
2024-09-10
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Insulin degludec
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
Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp®
Interventions
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Insulin degludec
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
Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp®
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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
Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre
Caen, , France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, , France
hôpital Saint Joseph Saint Luc
Lyon, , France
Centre Hospitalier Universitaire de Montpellier-Hopital Lapeyronie
Montpellier, , France
Ap-Hp-Hopital Bichat-Claude Bernard-1
Paris, , France
Hospices Civils de Lyon-Hopital Lyon Sud-2
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2
Toulouse, , France
Chru de Nancy - Hopital Brabois
Vandœuvre-lès-Nancy, , France
Diabetesmottagningen, Medicinkliniken, Södra Älvsborgs Sjukhus
Borås, , Sweden
Diabetesmottagningen, Södra Älvsborgs Sjukhus
Borås, , Sweden
Endokrinologiska kliniken, Malmö
Malmo, , Sweden
Medicinmottagning1 Universitetssjukhuset Örebro
Örebro, , Sweden
Centrum for Diabetes, Academical Specialist Centrum
Stockholm, , Sweden
Medicinkliniken Sundsv
Sundsvall, , Sweden
Uppsala universitetssjukhus
Uppsala, , Sweden
Frölunda Specialistsjukhus
Västra Frölunda, , Sweden
Countries
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Other Identifiers
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U1111-1255-5564
Identifier Type: OTHER
Identifier Source: secondary_id
DV3325-4759
Identifier Type: -
Identifier Source: org_study_id