🏛️ Verified NIH Record • Updated 2023-09-25

DETERMINE: Detemir vs NPH (NCT05124457)

A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of California, Los Angeles

🩺 Plain-English Summary (8th-Grade Level)

The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (10 items).

Location: University of California, Los Angeles — Los Angeles, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Multiple Gestation
  • Type 1 Diabetes mellatus
  • Age \< 18
  • Known or suspected hypersensitivity to NPH or insulin detemir
  • Known fetal major malformations
  • Chronic renal or hepatic insufficiency
  • Known to be HIV, Hepatitis B, or Hepatitis C positive
  • Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery)
  • Insulin dependent before conception

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • University of California, Los Angeles — Los Angeles, California

📞 Contact the Study Coordinator

Phone: (310) 794-7274

Email: mrichley@mednet.ucla.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗