An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry

Study Overview
=================
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.

Official Title
-----------------
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Levemir® (Insulin Detemir) in Pregnant Women With Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: other injectable antidiabetic treatment regimens


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br> | Drug: insulin detemir<br>* Patients will be treated according to routine clinical practice at the discretion of the treating physician<br>Drug: other injectable antidiabetic treatment regimens<br>* Patients will be treated according to routine clinical practice at the discretion of the treating physician<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major hypoglycaemia |  | During pregnancy | 
| 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 | 
| Proportion of pregnancies resulting in pre-term delivery |  | Assessed at delivery | 
| 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 |