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.
Study Type
OBSERVATIONAL
Enrollment
245
Participants with T1D will be treated with commercially available insulin icodec.
Change in glycated haemoglobin (HbA1c)
Measured as percentage (%) point of HbA1c.
Time frame: Baseline (week 0), week 26
Change in Insulin Treatment Satisfaction Questionnaire (ITSQ) score
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).
Time frame: Baseline (week 0), end of study (week 22-30)
Change in Adelphi Adherence Questionnaire (ADAQ) score
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.
Time frame: Baseline (week 0), end of study (week 22-30)
Number of self-reported overall severe hypoglycaemia
Measured as number of episodes.
Time frame: From baseline (week 0) to end of study (week 22-30)
Clinical success as perceived by the physician
Measured as count of participant per response option.
Time frame: From baseline (week 0) to end of study (week 22-30)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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RECRUITING...and 25 more locations