Status:
COMPLETED
Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy
Lead Sponsor:
St. Luke's-Roosevelt Hospital Center
Conditions:
Diabetes, Gestational
Diabetes, Type 2
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The aim of this study is to compare glycemic control in pregnant women treated with insulin Detemir and pregnant women treated with NPH insulin. These women are diagnosed with gestational diabetes (GD...
Detailed Description
The experimental method will be a randomized controlled trial performed at Roosevelt Hospital in our Diabetes in Pregnancy Program (DIPP). Perinatologists managing the patient in DIPP determine when p...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- All pregnant women with a viable singleton or multiple gestation at ≤34 weeks with gestational diabetes diagnosed in their current pregnancy requiring medical therapy. "Early diagnosis" GDM patients will also be included; which is defined as a diagnosis made prior to 24 weeks.
- Women with known preexisting type 2 diabetes that are in need of medical therapy.
- Exclusion criteria:
- Patients \<18 years of age
- a diagnosis of GDM outside of the gestational age stated above
- known allergy/prior adverse reaction to insulin NPH or insulin detemir.
- type 1 diabetes
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01837680
Start Date
March 1 2013
End Date
March 1 2015
Last Update
May 30 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019