iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes

N/ARecruitingNCT04206748

The University of Texas Health Science Center, Houston200 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Gestational Diabetes Type2 Diabetes Pregnancy in Diabetic

Interventions

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Neonatal morbidity

Time frame: at the time of discharge (about 2-7 days after birth)

Neonatal gestational age at delivery

Time frame: at delivery

# of neonates who where Small for gestational age (SGA)

Time frame: at delivery

Neonatal intensive care unit (NICU) length of stay

Time frame: delivery to discharge (2-7 days)

# of Neonates with hyperbilirubinemia-requiring therapy.

Time frame: delivery to discharge (2-7 days)

Secondary Outcomes

Average Neonatal Weight

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

Time frame: at the time of discharge (about 2-7 days after birth)

Maternal Mean fasting glucose

Time frame: perinatal to postpartum (32 weeks)

Maternal Mean post prandial glucose

Time frame: perinatal to postpartum (32 weeks)

Maternal # of Hypoglycemia events (<60 mg/dl)

Time frame: perinatal to postpartum (32 weeks)

Maternal weight gain during pregnancy

Time frame: perinatal to postpartum (32 weeks)

Maternal Gestational hypertension

Time frame: perinatal to postpartum (32 weeks)

Maternal Preeclampsia

Time frame: perinatal to postpartum (32 weeks)

Maternal Cesarean delivery

Time frame: at delivery

Maternal Operative vaginal delivery

Time frame: at delivery

Effect of SMBG checks on pregnancy

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.

Time frame: perinatal to postpartum (32 weeks)

iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts