iGlucoseae 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

What this Trial Is About

Researchers are evaluating whether using the iGlucose Smart Meter System, which automates glucose monitoring and provides reminders and clinician communication, improves health outcomes for women with gestational or type 2 diabetes during pregnancy. This randomized controlled trial compares this device as an addition to routine glucose meters with standard care using traditional glucose meters and diaries. The study is sponsored by The University of Texas Health Science Center, Houston. Participants in this trial will be assigned to one of two groups: one group will use the iGlucose Smart Meter System alongside their usual care, while the other group will use the prescribed routine glucose meter and manage their diabetes with traditional methods. The iGlucose device integrates self-monitoring blood glucose (SMBG) data with internet-based technology including cell phone reminders and feedback. The study focuses on women identified and consented before 30.6 weeks of pregnancy. During the study, researchers will monitor maternal glucose levels, hypoglycemia events, pregnancy complications, and delivery outcomes. Neonatal health will be assessed at delivery and discharge, including measures like neonatal morbidity, gestational age, NICU stay, and conditions such as hyperbilirubinemia and growth status. Maternal outcomes like weight gain, gestational hypertension, and delivery type will also be recorded. The trial involves regular data collection until about 32 weeks postpartum, with overall participation lasting through delivery and neonatal discharge.

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