Diabetes Mellitus, Type 2, Gestational Diabetes
Conditions
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.
Interventions
DRUGInsulin Detemir
Patients are to receive insulin detemir
DRUGInsulin NPH
Patients are to receive insulin NPH
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomization to receive either insulin NPH or insulin detemir
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Neonatal insulin level | At birth | Sample from cord blood |
| Neonatal leptin level | At birth | Sample from cord blood |
| Rates of pregnancy induced hypertension | 1 year | Maternal rates of preeclampsia, eclampsia, or gestational hypertension |
| Mode of delivery | At delivery | Spontaneous vaginal, operative vaginal, cesarean |
| Gestational Age at delivery | At delivery | Gestational Age at delivery |
| 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 |
| Neonatal Gastrin Level | At birth | Sample form cord blood |
| Macrosomia | At birth | Rate (%) of macrosomia |
| Polyhydramnios | At birth | Rate (%) of polyhydramnios |
| Neonatal weight | At birth | Neonatal weight |
| Need for supplemental oxygen | 1 year | Rate of supplemental oxygen use (%) in neonate |
| Need for dextrose infusion in neonate | 1 year | Rate of dextrose infusion use (%) in neonate |
| Rates of respiratory distress syndrome | 1 year | Rate of RDS (%) in neonate |
| 5 Minute APGAR | At birth | 5 Minute APGAR |
| Fetal anomolies | At birth | Rate (%) of fetal anomolies |
| Neonatal C-Peptide Level | At birth | Sample from cord blood |
Countries
United States
Contacts
Primary ContactMichael Richley, MD
Backup ContactChristina Han, MD
Outcome results
None listed