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Improving Outcomes in Underserved Women With GDM

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00774124
First Posted: October 17, 2008
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Temple University
  Purpose
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.

Condition Intervention
Diabetes Mellitus Pregnancy Other: telemonitoring Other: Standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Outcomes in Underserved Women With GDM

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • maternal blood glucose control [ Time Frame: 3 to 9 months ]

Secondary Outcome Measures:
  • infant birthweight [ Time Frame: at delivery ]

Enrollment: 57
Study Start Date: August 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of GDM
  • 33 or less weeks gestation

Exclusion Criteria:

  • multiple gestations
  • history of glucose intolerance outside of pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774124


Locations
United States, Florida
Tallahassee Memorial Diabetes Center
Tallahassee, Florida, United States, 32308
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Carol J Homko, RN, PhD Temple University
  More Information

Publications:
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00774124     History of Changes
Other Study ID Numbers: 071694
1R21DK071694 ( U.S. NIH Grant/Contract )
First Submitted: October 16, 2008
First Posted: October 17, 2008
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by Temple University:
GDM, pregnancy, macrosomia

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases