Gestational Diabetes, Pregnancy in Diabetic, Type2 Diabetes
Conditions
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
Interventions
DEVICEiGlucose Smart Meter System
Subjects will have routine care enhanced by use of theThe iGlucose Smart meter system. This is an example of integration of a SMBG system with internet-based technology; including cell phone notifications for reminders, feedback, and communication with clinicians
DEVICERoutine Care-RX meter
Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.
Sponsors
Smart Meter Corporation
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All patients \>/= women 18 years of age with gestational diabetes or type 2 diabetes during pregnancy and identified by the research team and consented before 30.6 weeks. * Non-anomalous singletons * Ability to provide informed consent
Exclusion criteria
* Patients with Type 1 diabetes * Patients with fetal major congenital abnormalities * Patients identified/referred after 30.6 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neonatal morbidity | at the time of discharge (about 2-7 days after birth) |
| Neonatal gestational age at delivery | at delivery |
| # of neonates who where Small for gestational age (SGA) | at delivery |
| Neonatal intensive care unit (NICU) length of stay | delivery to discharge (2-7 days) |
| # of Neonates with hyperbilirubinemia-requiring therapy. | delivery to discharge (2-7 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Gestational hypertension | perinatal to postpartum (32 weeks) | — |
| Maternal Preeclampsia | perinatal to postpartum (32 weeks) | — |
| Average Neonatal Weight | at the time of discharge (about 2-7 days after birth) | To evaluate the relationship of change in average neonatal weight to two skill sets of Self-monitoring of blood glucose (SMBG), operational and interpretive, as demonstrated by patient-perceived self-efficacy and adherence to self-care behaviors |
| Maternal Operative vaginal delivery | at delivery | — |
| Effect of SMBG checks on pregnancy | perinatal to postpartum (32 weeks) | To evaluate relationship between percent of total achieved SMBG checks, diabetes distress, and maternal and neonatal outcomes, for women living with GDM and T2DM during pregnancy. |
| Maternal Cesarean delivery | at delivery | — |
| Maternal Mean fasting glucose | perinatal to postpartum (32 weeks) | — |
| Maternal Mean post prandial glucose | perinatal to postpartum (32 weeks) | — |
| Maternal # of Hypoglycemia events (<60 mg/dl) | perinatal to postpartum (32 weeks) | — |
| Maternal weight gain during pregnancy | perinatal to postpartum (32 weeks) | — |
Countries
United States
Contacts
Primary ContactJoycelyn Corthwaite, RD
Backup ContactClara Ward, MD
Outcome results
None listed