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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT04206748
Status
Recruiting
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Conditions

  • Gestational Diabetes
  • Pregnancy in Diabetic
  • Type2 Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • iGlucose Smart Meter System — DEVICE
    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 — DEVICE
    Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.

Study Details

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

Key Dates

Start date
Nov 12, 2019
Status verified
Sep 2021
Primary completion
Nov 12, 2021
Completion
Nov 1, 2022

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: iGlucose Smart Meter
  • Placebo Comparator: Rx glucose meter

Primary Outcome Measure

Neonatal morbidity [ Time Frame: at the time of discharge (about 2-7 days after birth) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Joycelyn Cornthwaite, RD
[email protected]
832-325-7205
Sunbola Ashimi, PhD
[email protected]
713-500-6410

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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