RecruitingNCT07160816

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


Sponsor

Novo Nordisk A/S

Enrollment

245 participants

Start Date

Aug 28, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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).

Exclusion Criteria3

  • 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.

Interventions

DRUGInsulin icodec

Participants with T1D will be treated with commercially available insulin icodec.


Locations(35)

Hausärztliche und Diabetologische Praxis Pirna

Pirna, LÄK Sachsen, Germany

Zuckerpraxis Dr. Ewald Jammers

Bramsche, Germany

Studiengesellschaft Dres. Könemann/Steinmann GbR

Bünde, Germany

Diabeteszentrum-Do Dres. K U. Ch. Busch GbR

Dortmund, Germany

Diabeteszentrum Duisburg-Mitte

Duisburg, Germany

MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien

Fulda, Germany

Gemeinschaftspraxis Dr. Martin Grüneberg

Herne, Germany

Mesut Durmaz, Hof

Hof, Germany

Dr. Carola Lüke

Jerichow, Germany

Diabetespraxis Kiel

Kiel, Germany

Praxis Am Oberen Tor - Dr. Simon-Wagner

Lichtenfels, Germany

Diabetologie Dr. Eidenmüller

Marburg, Germany

Dr. Bernhard Landers

Mayen, Germany

Diabeteszentrum Bogenhausen

München, Germany

Medicover Neu-Ulm MVZ

Neu-Ulm, Germany

Diabetespraxis Oranienburg

Oranienburg, Germany

Diabetesschwerpunktpraxis Dr. Martina Lange

Rheinbach, Germany

Med.Versorgungszentrum Riesa-Dr. Bieler

Riesa, Germany

Dr. med. Carsten Schürfeld, GZ-Vauban

Saarlouis, Germany

Diabetespraxis Schorndorf Dr. Hensel

Schorndorf, Germany

Praxis Dr. Zimmermann

Sonsbeck, Germany

Endokrinologikum Ulm

Ulm, Germany

Diabetespraxis Viersen

Viersen, Germany

Ospedale San Raffaele S.r.l. - Unità Clinica Endocrinologia

Milan, Lombardy, Italy

Azienda Sanitaria Locale Città di Torino - Ambulatorio Endocrinologia e Malattie Metaboliche

Turin, Piedmont, Italy

AUSL Toscana Nord Ovest - Ospedali Riuniti di Livorno - Diabetologia e Malattie del Metabolismo

Livorno, Tuscany, Italy

AUSL Toscana Nord Ovest - Cittadella della Salute Campo di Marte - Diabetologia Lucca e Valle del Serchio

Lucca, Tuscany, Italy

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

Azienda Ospedaliero-Universitaria Renato Dulbecco

Catanzaro, Italy

Azienda Ospedaliera Luigi Sacco

Milan, Italy

A.O.U. Università Studi della Campania "Luigi Vanvitelli"

Naples, Italy

Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia

Perugia, Italy

DIABETOLOGIA Ravenna AUSL della Romagna

Ravenna, Italy

Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche

Rome, Italy

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NCT07160816


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