NCT04206748

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Gestational Diabetes
• Type2 Diabetes
• Pregnancy in Diabetic

Interventions

Type	Name	Description
DEVICE	iGlucose 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
DEVICE	Routine Care-RX meter	Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.

Timeline

• Start date: 2019-11-12
• Primary completion: 2021-11-12
• Completion: 2022-11-01
• First posted: 2019-12-20
• Last updated: 2021-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study