Improving Outcomes in Underserved Women With GDM

Diabetes Mellitus Clinical Trial

Official title:

Improving Outcomes in Underserved Women With GDM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774124
• Other study ID #: 071694
• Secondary ID: 1R21DK071694
• Status: Completed
• Phase: N/A
• First received: October 16, 2008
• Last updated: October 18, 2017
• Start date: August 2007
• Est. completion date: July 2010

Study information

• Verified date: October 2017
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• diagnosis of GDM

• 33 or less weeks gestation

Exclusion Criteria:

• multiple gestations

• history of glucose intolerance outside of pregnancy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pregnancy

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Tallahassee Memorial Diabetes Center	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Technol Ther. 2007 Jun;9(3):297-306. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maternal blood glucose control		3 to 9 months
Secondary	infant birthweight		at delivery