Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.
Interventions
DRUGinsulin detemir
Patients will be treated according to routine clinical practice at the discretion of the treating physician
DRUGother injectable antidiabetic treatment regimens
Patients will be treated according to routine clinical practice at the discretion of the treating physician
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
- Informed consent obtained before any data collection - Woman with a positive pregnancy test - Diabetes mellitus type 1 or 2, diagnosed prior to conception - Currently treated with Levemir® or other injectable antidiabetic treatment(s) - Unchanged basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception
Exclusion criteria
- Women who have been pregnant for more than 16 weeks at baseline visit will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of pregnancies (Levemir® treatment), compared to pregnancies (other basal insulin treatment regimens), resulting in none of the following events: Major congenital malformations, Perinatal death, Neonatal death | Assessed up to 4 weeks after delivery |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of pregnancies complicated by pre-eclampsia | During pregnancy |
| Proportion of pregnancies resulting in perinatal death | Assessed 1 week after delivery |
| Proportion of pregnancies resulting in neonatal death | Assessed 4 weeks after delivery |
| Proportion of pregnancies resulting in spontaneous abortion | Assessed at pregnancy termination |
| Incidence of major hypoglycaemia | During pregnancy |
| Height | At the age of 1 year |
| Weight | At the age of 1 year |
| Proportion with changes (progression/regression) of major congenital malformations | At the age of 1 year |
| Proportion of pregnancies resulting in pre-term delivery | Assessed at delivery |
Countries
Croatia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Malaysia, Netherlands, Norway, Poland, Portugal, Romania, Spain, United Kingdom
Outcome results
None listed