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

NCT ID: NCT04206748

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-12

Study Completion Date

2022-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Diabetes Type2 Diabetes Pregnancy in Diabetic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

iGlucose Smart Meter

Group Type EXPERIMENTAL

iGlucose Smart Meter System

Intervention Type 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

Rx glucose meter

Group Type PLACEBO_COMPARATOR

Routine Care-RX meter

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Routine Care-RX meter

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Smart Meter Corporation

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joycelyn Ashby Cornthwaite

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Joycelyn Corthwaite, RD

Role: CONTACT

832-325-7205

Clara Ward, MD

Role: CONTACT

713-500-6412

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Joycelyn Cornthwaite, RD

Role: primary

832-325-7205

Sunbola Ashimi, PhD

Role: backup

713-500-6410

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSC-MS-19-0402

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Novel Device for Gestational Diabetes Control
NCT05812547 NOT_YET_RECRUITING NA