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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
iGlucose Smart Meter
  • 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
Placebo Comparator
Rx glucose meter
  • Device: Routine Care-RX meter
    Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Joycelyn Cornthwaite, RD
832-325-7205
joycelyn.a.cornthwaite@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Joycelyn Corthwaite, RD
832-325-7205
joycelyn.a.cornthwaite@uth.tmc.edu