Improving Outcomes in Underserved Women With GDM

October 18, 2017 updated by: Temple University
Our objective is to test an innovative approach to improve outcomes among underserved women with gestational diabetes. We ill utilize a multi-lingual, Interactive Voice Response (IVR) -enabled telephone system to facilitate diabetes control and thereby improve pregnancy outcomes. Our hypothesis is that Telemonitoring will improve maternal glycemia, thereby reducing infant birth weights and leading to improved pregnancy outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Using a step care design, women will be randomized into standard of care or Telemonitoring. In the standard of care group, women will monitor their blood glucose levels four times a day, perform fetal movement counting three times a day and also record insulin doses. The women will record this information in a logbook, which will be reviewed by the medical team at prenatal visits. In the Telemonitoring group, women will receive the standard of care anmd will also transmit their blood glucose and fetal movement information to their health care providers.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Diabetes Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • diagnosis of GDM
  • 33 or less weeks gestation

Exclusion Criteria:

  • multiple gestations
  • history of glucose intolerance outside of pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Telemedicine
Usual care plus telemonitoring
Other: telemonitoring
Women will transmit their blood glucose levels, fetal movement counts, and insulin doses via the Internet and/or IVR system at least three times per week
Active Comparator: 2 Standard of Care
Standard of care - women will monitor and record blood glucose levels four times a day.
Other: Standard of care
Health data (blood glucose levels and insulin doses) will be recorded in a paper log book which will be reviewed at prenatal visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maternal blood glucose control
Time Frame: 3 to 9 months
3 to 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
infant birthweight
Time Frame: at delivery
at delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Carol J Homko, RN, PhD, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (Estimate)

October 17, 2008

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 071694
  • 1R21DK071694 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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