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

The University of Texas System (UT)

Status: Enrolling

Conditions: Gestational Diabetes; Pregnancy in Diabetic; Type2 Diabetes

Treatments: Device: iGlucose Smart Meter System; Device: Routine Care-RX meter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04206748

HSC-MS-19-0402

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

iGlucose Smart Meter

Experimental group

Treatment:

Device: iGlucose Smart Meter System

Rx glucose meter

Placebo Comparator group

Treatment:

Device: Routine Care-RX meter