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Clinical Trial Details

Trial ID: L2510
Source ID: NCT01837680
Associated Drug: Insulin
Title: Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01837680/results
Conditions: Diabetes, Gestational|Diabetes, Type 2
Interventions: DRUG: Insulin
Outcome Measures: Primary: Glycemic Control, Overall mean glucose value of pregnancy. This will be determined by the sum of average glucose value at each visit, divided by the number of visits., up to 41 weeks | Secondary: Number of Patients Obtaining Glycemic Control, Number of each group that obtains glycemic control, defined as mean glucose \<100mg/dl., up to 41 weeks|Time to Achieve Glycemic Control, Time (weeks) to achieve glycemic control, as defined as mean glucose \<100mg/dl, up to 41 weeks|Average Fasting Glucose, Mean fasting blood glucose in pregnancy, as determined by the sum of the mean fasting glucose at each visit divided by the number of visits, up to 41 weeks|Post-prandial Blood Glucose, Mean post-prandial blood glucose in pregnancy, as defined as the sum of the average post-prandial blood glucose at each visit divided by the number of visits., up to 41 weeks|Weight Gain, Total weight gain in pregnancy, Number of pounds gained at each visit up to 41 weeks|Neonatal Weight, Neonatal weight was estimated for occurrence of neonatal macrosomia (≥4000g birth weight) and neonatal LGA(large for gestational age)(birth weight \>90th percentile for gestational age, At delivery, up to 41 weeks|Gestational Age at Delivery, Gestational age at delivery, at delivery, up to 41 weeks|Maternal Hypoglycemia, Number of participants with incidence of maternal hypoglycemia (\<60mg/dl), at delivery, up to 41 weeks|Neonatal Bilirubin, Percentage of neonatal hyperbilirubinemia - data not collected, at birth, up to 41 weeks|Intensive Care Admissions, Number of participants with incidence of neonatal intensive care unit admissions, at birth, up to 41 weeks|Delivery Mode, method of delivery including cesarean section, vaginal delivery, or assisted vaginal delivery - data not collected, at birth, up to 41 weeks|Birth Rate, Number of live birth rate, at birth, up to 41 weeks|Shoulder Dystocia, Incidence of shoulder dystocia - data not collected, at birth, up to 41 weeks|Polyhydramnios, Incidence of polyhydramnios (defined as amniotic fluid index (AFI)\>20 or deepest vertical pocket ≥8) - data not collected, at each visit in pregnancy up to 41 weeks|Neonatal Hypoglycemia, Number of participants with incidence of blood sugar \<40mg/dl in neonate, at birth, up to 41 weeks
Sponsor/Collaborators: Sponsor: St. Luke's-Roosevelt Hospital Center
Gender: FEMALE
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 105
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-03
Completion Date: 2015-03
Results First Posted: 2017-05-30
Last Update Posted: 2017-05-30
Locations: St. Luke's-Roosevelt Hospital Center, New York, New York, 10019, United States
URL: https://clinicaltrials.gov/show/NCT01837680