Diabetes Mellitus, Type 1
Conditions
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.
Interventions
DRUGInsulin icodec
Participants with T1D will be treated with commercially available insulin icodec.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Baseline (week 0), week 26 | Measured as percentage (%) point of HbA1c. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Treatment Satisfaction Questionnaire (ITSQ) score | Baseline (week 0), end of study (week 22-30) | ITSQ measures insulin treatment satisfaction, applicable to a wide range of insulin therapies. The ITSQ consists of 22 items yielding 5 domain scores and a total score. The domains consist of Regimen inconvenience (5 items), Lifestyle flexibility (3 items), Glycemic control (3 items), Hypoglycemic control (5 items), and Satisfaction with the insulin delivery device (6 items). The domain and global ITSQ score both ranges from 0-100.Higher scores indicate a better health state (less negative impact). |
| Change in Adelphi Adherence Questionnaire (ADAQ) score | Baseline (week 0), end of study (week 22-30) | The ADAQ measure consists of 11 items scored on a scale of 0 to 4. The mean of the individual items represents the total ADAQ score. At least 8 of the 11 items must be answered to calculate the ADAQ score. The lower the score corresponds to the greater adherence. |
| Number of self-reported overall severe hypoglycaemia | From baseline (week 0) to end of study (week 22-30) | Measured as number of episodes. |
| Clinical success as perceived by the physician | From baseline (week 0) to end of study (week 22-30) | Measured as count of participant per response option. |
Countries
Germany, Italy
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed