A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar
A Real-world, Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control, Treatment Satisfaction and Adherence Associated With the Use of Insulin Icodec in People Living With Type 1 Diabetes
2 other identifiers
observational
245
2 countries
35
Brief Summary
The study will look at how well insulin icodec controls blood sugar levels in participants who have never used it before. Participants with type 1 diabetes (T1D) will be treated with insulin icodec as prescribed to by their doctor, in accordance with usual clinical practice. This study will last for about 22 to 30 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2025
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2025
CompletedFirst Submitted
Initial submission to the registry
August 29, 2025
CompletedFirst Posted
Study publicly available on registry
September 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 20, 2027
January 9, 2026
January 1, 2026
1.4 years
August 29, 2025
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in glycated haemoglobin (HbA1c)
Measured as percentage (%) point of HbA1c.
Baseline (week 0), week 26
Secondary Outcomes (4)
Change in Insulin Treatment Satisfaction Questionnaire (ITSQ) score
Baseline (week 0), end of study (week 22-30)
Change in Adelphi Adherence Questionnaire (ADAQ) score
Baseline (week 0), end of study (week 22-30)
Number of self-reported overall severe hypoglycaemia
From baseline (week 0) to end of study (week 22-30)
Clinical success as perceived by the physician
From baseline (week 0) to end of study (week 22-30)
Study Arms (1)
Insulin icodec
Participants with T1D will be treated with commercially available insulin icodec according to routine clinical practice at the discretion of the treating physician.
Interventions
Participants with T1D will be treated with commercially available insulin icodec.
Eligibility Criteria
The study population comprises participants who are diagnosed with type 1 diabetes and agree to be treated with insulin icodec after consultation with their physician independently from the decision to participate in this study.
You may qualify if:
- Signed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to the protocol).
- The decision to initiate treatment with commercially available insulin icodec has been made by the participant/legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.
- Male or female, age greater than or equal to (≥) 18 years at the time of signing informed consent.
- Diagnosed with T1D ≥ 1 year before signing informed consent.
- Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before signing informed consent.
- Available HbA1c value less than or equal to (≤) 90 days prior to the 'Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Initiation visit' (V1) if in line with local clinical practice.
- Treatment naïve to once-weekly insulin prior to the 'Initiation Visit' (V1).
You may not qualify if:
- Previous participation in this study. Participation is defined as having given informed 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (35)
Hausärztliche und Diabetologische Praxis Pirna
Pirna, LÄK Sachsen, 01796, Germany
Zuckerpraxis Dr. Ewald Jammers
Bramsche, 49565, Germany
Studiengesellschaft Dres. Könemann/Steinmann GbR
Bünde, 32257, Germany
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
Dortmund, 44137, Germany
Diabeteszentrum Duisburg-Mitte
Duisburg, 47051, Germany
MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
Fulda, 36037, Germany
Gemeinschaftspraxis Dr. Martin Grüneberg
Herne, 64649, Germany
Mesut Durmaz, Hof
Hof, 95030, Germany
Dr. Carola Lüke
Jerichow, 39319, Germany
Diabetespraxis Kiel
Kiel, 24114, Germany
Praxis Am Oberen Tor - Dr. Simon-Wagner
Lichtenfels, 96215, Germany
Diabetologie Dr. Eidenmüller
Marburg, 35037, Germany
Dr. Bernhard Landers
Mayen, 56727, Germany
Diabeteszentrum Bogenhausen
München, 81927, Germany
Medicover Neu-Ulm MVZ
Neu-Ulm, 89231, Germany
Diabetespraxis Oranienburg
Oranienburg, 16515, Germany
Diabetesschwerpunktpraxis Dr. Martina Lange
Rheinbach, 53359, Germany
Med.Versorgungszentrum Riesa-Dr. Bieler
Riesa, 01587, Germany
Dr. med. Carsten Schürfeld, GZ-Vauban
Saarlouis, 66740, Germany
Diabetespraxis Schorndorf Dr. Hensel
Schorndorf, 73614, Germany
Praxis Dr. Zimmermann
Sonsbeck, 47665, Germany
Endokrinologikum Ulm
Ulm, 89073, Germany
Diabetespraxis Viersen
Viersen, 41747, Germany
Ospedale San Raffaele S.r.l. - Unità Clinica Endocrinologia
Milan, Lombardy, 20132, Italy
Azienda Sanitaria Locale Città di Torino - Ambulatorio Endocrinologia e Malattie Metaboliche
Turin, Piedmont, 10122, Italy
AUSL Toscana Nord Ovest - Ospedali Riuniti di Livorno - Diabetologia e Malattie del Metabolismo
Livorno, Tuscany, 57124, Italy
AUSL Toscana Nord Ovest - Cittadella della Salute Campo di Marte - Diabetologia Lucca e Valle del Serchio
Lucca, Tuscany, 55100, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, 88100, Italy
Azienda Ospedaliera Luigi Sacco
Milan, 20157, Italy
A.O.U. Università Studi della Campania "Luigi Vanvitelli"
Naples, 80138, Italy
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
Perugia, 06129, Italy
DIABETOLOGIA Ravenna AUSL della Romagna
Ravenna, 48121, Italy
Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale
Roma, 00161, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche
Rome, 00168, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2025
First Posted
September 8, 2025
Study Start
August 28, 2025
Primary Completion (Estimated)
January 20, 2027
Study Completion (Estimated)
January 20, 2027
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com