Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 16 of 16

List	Outcome	Time frame	Description
Primary	Glycemic Control	up to 41 weeks	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.
Secondary	Number of Patients Obtaining Glycemic Control	up to 41 weeks	Number of each group that obtains glycemic control, defined as mean glucose \<100mg/dl.
Secondary	Time to Achieve Glycemic Control	up to 41 weeks	Time (weeks) to achieve glycemic control, as defined as mean glucose \<100mg/dl
Secondary	Average Fasting Glucose	up to 41 weeks	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
Secondary	Post-prandial Blood Glucose	up to 41 weeks	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.
Secondary	Weight Gain	Number of pounds gained at each visit up to 41 weeks	Total weight gain in pregnancy
Secondary	Neonatal Weight	At delivery, up to 41 weeks	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
Secondary	Gestational Age at Delivery	at delivery, up to 41 weeks	Gestational age at delivery
Secondary	Maternal Hypoglycemia	at delivery, up to 41 weeks	Number of participants with incidence of maternal hypoglycemia (\<60mg/dl)
Secondary	Neonatal Bilirubin	at birth, up to 41 weeks	Percentage of neonatal hyperbilirubinemia - data not collected
Secondary	Intensive Care Admissions	at birth, up to 41 weeks	Number of participants with incidence of neonatal intensive care unit admissions
Secondary	Delivery Mode	at birth, up to 41 weeks	method of delivery including cesarean section, vaginal delivery, or assisted vaginal delivery - data not collected
Secondary	Birth Rate	at birth, up to 41 weeks	Number of live birth rate
Secondary	Shoulder Dystocia	at birth, up to 41 weeks	Incidence of shoulder dystocia - data not collected
Secondary	Polyhydramnios	at each visit in pregnancy up to 41 weeks	Incidence of polyhydramnios (defined as amniotic fluid index (AFI)\>20 or deepest vertical pocket ≥8) - data not collected
Secondary	Neonatal Hypoglycemia	at birth, up to 41 weeks	Number of participants with incidence of blood sugar \<40mg/dl in neonate

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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