Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Europe. The aim of this study is to assess the well-being of patients following treatment with insulin detemir (Levemir®) in subjects with type 1 or type 2 diabetes in whom either initiation of or a switch to insulin treatment with a long-acting basal insulin analogue is needed.
Interventions
DRUGinsulin detemir
Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any subject with type 1 or type 2 diabetes not optimally controlled (HbA1c above 7.5%) in whom at the discretion of the participating physicians it was decide to either initiate or switch to a treatment with a long-acting insulin analogue * Subjects with type 1 diabetes should have been treated with insulin for at least 12 months * Potential pre-study treatment with insulin detemir (Levemir®) should have started no more than two months before baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS) | Baseline, month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c (glycosylated haemoglobin) | Baseline, month 6 |
| Change in Fasting blood glucose (FBG) | Baseline, month 6 |
| Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ) | Baseline, month 6 |
| Hypoglycaemic episodes | Month 6 |
| Adverse events | Month 6 |
| Change in body weight | Baseline, month 6 |
Countries
Netherlands
Outcome results
None listed