iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes: a Pilot Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Neonatal morbidity
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to investigate whether automation of glucose monitoring data to facilitate the total number of recommended and completed SMBG checks improve clinical outcomes for women living with gestational and type 2 diabetes during pregnancy? This is a RCT
Investigators
Joycelyn Ashby Cornthwaite
Assistant Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Neonatal morbidity
Time Frame: at the time of discharge (about 2-7 days after birth)
Neonatal intensive care unit (NICU) length of stay
Time Frame: delivery to discharge (2-7 days)
# of neonates who where Small for gestational age (SGA)
Time Frame: at delivery
Neonatal gestational age at delivery
Time Frame: at delivery
# of Neonates with hyperbilirubinemia-requiring therapy.
Time Frame: delivery to discharge (2-7 days)
Secondary Outcomes
- Maternal Mean post prandial glucose(perinatal to postpartum (32 weeks))
- Average Neonatal Weight(at the time of discharge (about 2-7 days after birth))
- Maternal # of Hypoglycemia events (<60 mg/dl)(perinatal to postpartum (32 weeks))
- Maternal weight gain during pregnancy(perinatal to postpartum (32 weeks))
- Maternal Preeclampsia(perinatal to postpartum (32 weeks))
- Maternal Mean fasting glucose(perinatal to postpartum (32 weeks))
- Maternal Cesarean delivery(at delivery)
- Effect of SMBG checks on pregnancy(perinatal to postpartum (32 weeks))
- Maternal Gestational hypertension(perinatal to postpartum (32 weeks))
- Maternal Operative vaginal delivery(at delivery)