Investigating the Safety and Effectiveness of Insulin Degludec in a Real World Population With Type 1 and 2 Diabetes Mellitus

A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus

This study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.

Inclusion Criteria:

• Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
• Male or female patients at least 18 years of age at time of informed consent
• T1DM (diagnosed clinically) prior to inclusion in the study, and/or T2DM, insulin using patients (diagnosed clinically) prior to inclusion in the study
• Planned initiation with Tresiba®

Exclusion Criteria:

• Known or suspected hypersensitivity to Tresiba® or any of the excipients listed in Section 6.1 of the SmPC (Summary of Product Characteristics) or related products
• Previous participation in this study (i.e. provision of informed consent)
• Patients who have previously been treated with Tresiba®
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation