Improving Outcomes in Underserved Women With GDM

This study has been completed.
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00774124
First received: October 16, 2008
Last updated: August 3, 2011
Last verified: October 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • infant birthweight [ Time Frame: at delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Carol J Homko, RN, PhD Temple University
  More Information

Publications:
Homko CJ, Santamore WP, Whiteman V, Bower M, Berger P, Geifman-Holtzman O, Bove AA. Use of an Internet based telemedicine system to manage underserved women with gestational diabetes mellitus Diabetes Technology & Therapeutics 9(3):277286, 2007

Responsible Party: Carol Homko, RN, PhD, Temple University
ClinicalTrials.gov Identifier: NCT00774124     History of Changes
Other Study ID Numbers: 071694, 1R21DK071694
Study First Received: October 16, 2008
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
GDM, pregnancy, macrosomia

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

ClinicalTrials.gov processed this record on September 22, 2014