Recruiting

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

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04206748

Conditions

Gestational Diabetes

Type2 Diabetes

Pregnancy in Diabetic

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

iGlucose Smart Meter System

Routine Care-RX meter

Study Details

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

Conditions

Gestational Diabetes

Type2 Diabetes

Pregnancy in Diabetic

Study ID

NCT04206748

Start date

Nov 12, 2019

Status verified date

Sep, 2021

Completion date

Nov 1, 2022

Anticipated

Primary completion date

Nov 12, 2021

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: iGlucose Smart Meter

placebo comparator: Rx glucose meter

Interventions

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

Routine Care-RX meter

Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.

Primary outcome measure

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) ]

Central Contacts and Locations

Central contacts

Joycelyn Corthwaite, RD

832-325-7205 joycelyn.a.cornthwaite@uth.tmc.edu

Clara Ward, MD

713-500-6412 clara.ward@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Joycelyn Cornthwaite, RD

832-325-7205 joycelyn.a.cornthwaite@uth.tmc.edu

Sunbola Ashimi, PhD

713-500-6410 sunbola.s.ashimi@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Sep 2, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2021-09-02.