RecruitingNot ApplicableNCT04206748

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

200 participants

Start Date

Nov 12, 2019

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • Patients with Type 1 diabetes
  • Patients with fetal major congenital abnormalities
  • Patients identified/referred after 30.6 weeks

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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.


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT04206748


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