NCT05124457 · University of California, Los Angeles
DETERMINE: Detemir vs NPH
(DETERMINE)
What this study is about
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
View original scientific description
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
Interventions
DRUG
Insulin Detemir
Patients are to receive insulin detemir
DRUG
Insulin NPH
Patients are to receive insulin NPH
Primary outcome measures
Neonatal Hypoglycemia
Time frame: Within the first 24 hours of life
Rate (%) of neonatal hypoglycemia
Prolonged neonatal hypoglycemia
Time frame: Neonatal hypoglycemia after the 1st 24 hours of life but before discharge
Rate (%) of prolonged neonatal hypoglycemia
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Exclusion criteria
- Multiple Gestation
- Type 1 Diabetes mellatus
- 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
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 26, 2023 · Source of record for eligibility and locations