DETERMINE: Detemir vs NPH
- Conditions
- Gestational DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT05124457
- Lead Sponsor
- University of California, Los Angeles
- Brief Summary
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
- Detailed Description
Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 336
- Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin NPH Insulin NPH Patients are to receive insulin NPH as long acting insulin to control blood sugars Insulin Detemir Insulin Detemir Patients are to receive insulin detemir as long acting insulin to control blood sugars
- Primary Outcome Measures
Name Time Method Neonatal Hypoglycemia Within the first 24 hours of life Rate (%) of neonatal hypoglycemia
Prolonged neonatal hypoglycemia Neonatal hypoglycemia after the 1st 24 hours of life but before discharge Rate (%) of prolonged neonatal hypoglycemia
- Secondary Outcome Measures
Name Time Method Gestational Age at delivery At delivery Gestational Age at delivery
Neonatal weight At birth Neonatal weight
Rates of respiratory distress syndrome 1 year Rate of RDS (%) in neonate
5 Minute APGAR At birth 5 Minute APGAR
Need for dextrose infusion in neonate 1 year Rate of dextrose infusion use (%) in neonate
Neonatal Gastrin Level At birth Sample form cord blood
Neonatal C-Peptide Level At birth Sample from cord blood
Polyhydramnios At birth Rate (%) of polyhydramnios
Mode of delivery At delivery Spontaneous vaginal, operative vaginal, cesarean
Neonatal insulin level At birth Sample from cord blood
Rates of pregnancy induced hypertension 1 year Maternal rates of preeclampsia, eclampsia, or gestational hypertension
Fetal anomolies At birth Rate (%) of fetal anomolies
Macrosomia At birth Rate (%) of macrosomia
Need for supplemental oxygen 1 year Rate of supplemental oxygen use (%) in neonate
Neonatal leptin level At birth Sample from cord blood
Maternal glycemic control 1 year Rate (%) of in range maternal blood glucose control in antepartum period
Total daily insulin 1 year Total daily insulin dose in patient
Trial Locations
- Locations (1)
University of California, Los Angeles
🇺🇸Los Angeles, California, United States