NCT00774124

Improving Outcomes in Underserved Women With GDM

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetes Mellitus
• Pregnancy

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-10-17
• Last updated: 2017-10-20

Locations

2 sites across 1 country: United States