RECRUITING
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DETERMINE: Detemir vs NPH
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
Conditions:
🦠 Gestational Diabetes 🦠 Diabetes Mellitus, Type 2
🗓️ Study Start (Actual) 1 February 2022
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) June 2025
👥 Enrollment (Estimated) 336
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 October 2021
  • First Submitted that Met QC Criteria 5 November 2021
  • First Posted 18 November 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 September 2023
  • Last Update Posted 26 September 2023
  • Last Verified September 2023
I'm interested ...!!