Comparing Insulin Detemir and Insulin NPH for Diabetes in Pregnancy

This study, called DETERMINE, is comparing two insulin treatments, Insulin Detemir and Insulin NPH, for pregnant women with gestational diabetes or pre-existing type 2 diabetes who need insulin to manage their blood sugar. The main goal is to see if one insulin leads to fewer cases of neonatal hypoglycemia (low blood sugar in newborns) within the first 24 hours of life, and also fewer cases of prolonged neonatal hypoglycemia. You may be able to join if you are pregnant, 18 or older, and have gestational diabetes or type 2 diabetes requiring insulin. You cannot join if you have multiple pregnancies, type 1 diabetes, known allergies to these insulins, known fetal major malformations, or chronic kidney or liver problems. The current status of this study is unclear.

Study design
This study aims to enroll 336 participants to compare Insulin Detemir and Insulin NPH. It is an interventional study, meaning participants will receive one of the two insulin treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure neonatal hypoglycemia within the first 24 hours of life and prolonged neonatal hypoglycemia before the baby is discharged from the hospital.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05124457

DETERMINE: Detemir vs NPH

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of California, Los Angeles
~336 participants
Updated 2023-09-26 on ClinicalTrials.gov
What's tested:Insulin DetemirInsulin NPH

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neonatal Hypoglycemia
Measured over Within the first 24 hours of life
+1 more outcome measured
Gestational Diabetes
Diabetes Mellitus, Type 2
1 sites across 1 states
California1
  • Christina Han, MD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
  • Michael Richley, MD · STUDY_DIRECTOR · University of California, Los Angeles

Opens a ready-to-send draft in your own email app — review before sending.

  • Neonatal HypoglycemiaWithin the first 24 hours of life

    Rate (%) of neonatal hypoglycemia

  • Prolonged neonatal hypoglycemiaNeonatal hypoglycemia after the 1st 24 hours of life but before discharge

    Rate (%) of prolonged neonatal hypoglycemia