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OpenTrials
Completed

NCT Number: NCT00774124

Improving Outcomes in Underserved Women With GDM

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tallahassee Memorial Diabetes Center, Tallahassee, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of GDM
  • 33 or less weeks gestation

Exclusion criteria

  • multiple gestations
  • history of glucose intolerance outside of pregnancy

Treatment and study plan

Telemonitoring

Other

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

Standard of care

Other

Health data (blood glucose levels and insulin doses) will be recorded in a paper log book which will be reviewed at prenatal visits.

Primary outcomes

  1. maternal blood glucose control

    Time frame: 3 to 9 months

Secondary outcomes

  1. infant birthweight

    Time frame: at delivery

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 17, 2008
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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