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

NCT04206748 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-09-02

No results posted yet for this study

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

Interventions

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

DEVICE

Routine Care-RX meter

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

Sponsors & Collaborators

  • Smart Meter Corporation

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2021-11-12
Completion
2022-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04206748 on ClinicalTrials.gov