RECRUITINGOBSERVATIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form.
- Diagnosed with T1D ≥ 1 year before signing willing to sign a consent form.
- Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before signing willing to sign a consent form.
- 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).
Who Should NOT Join This Trial:
- Previous participation in this study. Participation is defined as having given willing to sign a consent form 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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 Criteria:
* 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.
Treatments Being Tested
DRUG
Insulin icodec
Participants with T1D will be treated with commercially available insulin icodec.
Locations (20)
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