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 | Completed

• 2 other identifiers: DV3325-4759U1111-1255-5564
• Study Type: observational
• Target: 411
• Locations: 4 countries
• Sites: 26

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in time in range (3.9-10 mmol/L)

  Percentage change (absolute) (Using available rtCGM (Real-Time Continuous Glucose Monitoring) and isCGM data(Intermittent-scanning Continuous Glucose Monitoring))

  Baseline (Day -14 to Day 0) to End of Study (Day 280)

Secondary Outcomes (11)

• Change in time in hyperglycaemia/above range Level 1 (10.1 - 13.9 mmol/L)

  Baseline (Day -14 to Day 0) to End of Study (Day 280)

• Change in time in hyperglycaemia/above range Level 2 (greater than 13.9 mmol/L)

  Baseline (Day -14 to Day 0) to End of Study (Day 280)

• Change in time in hypoglycaemia/below range Level 1 (3.0-3.8 mmol/L)

  Baseline (Day -14 to Day 0) to End of Study (Day 280)

• Change in time in hypoglycaemia/below range Level 2 (below 3.0 mmol/L)

  Baseline (Day -14 to Day 0) to End of Study (Day 280)

• Change in mean glucose

  Baseline (Day -14 to Day 0) to End of Study (Day 280)

Study Arms (1)

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

Drug: Insulin degludec; Drug: Fast-acting insulin aspart

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®

Tresiba + Fiasp using NovoPen 6 per local label

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®

Tresiba + Fiasp using NovoPen 6 per local label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will use Tresiba® and Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (26)

Imeldaziekenhuis - Bonheiden - Department of Endocrinology

Bonheiden, 2820, Belgium

Location

HUB - Hôpital Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

Brussels, 1200, Belgium

Location

UZA - UZ Antwerpen - Department of Endocrinology

Edegem, 2650, Belgium

Location

UZ Leuven - Endocrinology

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Aarhus Universitetshospital Diabetes og Hormonsygdomme

Aarhus N, 8200, Denmark

Location

Bispebjerg Hospital, IC-Forskning

Copenhagen, 2400, Denmark

Location

Medicinsk Afdeling B, Herning Centralsygehus

Herning, 7400, Denmark

Location

Regionshospitalet Silkeborg - Endokrinologisk afd.

Silkeborg, 8600, Denmark

Location

Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre

Caen, 14033, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

hôpital Saint Joseph Saint Luc

Lyon, 69365, France

Location

Centre Hospitalier Universitaire de Montpellier-Hopital Lapeyronie

Montpellier, 34295, France

Location

Ap-Hp-Hopital Bichat-Claude Bernard-1

Paris, 75877, France

Location

Hospices Civils de Lyon-Hopital Lyon Sud-2

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2

Toulouse, 31054, France

Location

Chru de Nancy - Hopital Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Diabetesmottagningen, Medicinkliniken, Södra Älvsborgs Sjukhus

Borås, 501 82, Sweden

Location

Diabetesmottagningen, Södra Älvsborgs Sjukhus

Borås, 501 82, Sweden

Location

Endokrinologiska kliniken, Malmö

Malmo, 205 02, Sweden

Location

Medicinmottagning1 Universitetssjukhuset Örebro

Örebro, 701 85, Sweden

Location

Centrum for Diabetes, Academical Specialist Centrum

Stockholm, 113 65, Sweden

Location

Medicinkliniken Sundsv

Sundsvall, 851 86, Sweden

Location

Uppsala universitetssjukhus

Uppsala, 751 85, Sweden

Location

Frölunda Specialistsjukhus

Västra Frölunda, 42144, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 6, 2021
• Study Start: October 11, 2021
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

FR (8); DK (4); SE (8); BE (6)