Comparing Insulin Detemir and NPH for Managing Diabetes in Pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the rates of neonatal hypoglycemia in pregnant women with gestational diabetes or type 2 diabetes who are treated with either insulin detemir or NPH. Insulin detemir is already FDA approved for use in pregnant women with type 1 diabetes, while NPH is the only long-acting insulin approved for type 2 diabetes and gestational diabetes. The study will evaluate the safety and efficacy of these two insulin types in managing blood sugar levels during pregnancy, focusing on the potential risks to newborns. By understanding the differences in hypoglycemia rates between these two treatments, the study seeks to improve maternal and neonatal outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.

Exclusion Criteria:

1. Multiple Gestation
2. Type 1 Diabetes mellatus
3. Age \< 18
4. Known or suspected hypersensitivity to NPH or insulin detemir
5. Known fetal major malformations
6. Chronic renal or hepatic insufficiency
7. Known to be HIV, Hepatitis B, or Hepatitis C positive
8. Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery)
9. Insulin dependent before conception

Where it's running

• University of California, Los Angeles
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Christina Han, MD — University of California, Los Angeles
• Study coordinator: Michael Richley, MD
• Email: mrichley@mednet.ucla.edu
• Phone: 310-794-7274

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.