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.
|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|
- maternal blood glucose control [ Time Frame: 3 to 9 months ] [ Designated as safety issue: Yes ]
- infant birthweight [ Time Frame: at delivery ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: 1 Telemedicine
Usual care plus 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774124
|United States, Florida|
|Tallahassee Memorial Diabetes Center|
|Tallahassee, Florida, United States, 32308|
|United States, Pennsylvania|
|Temple University Hospital|
|Philadelphia, Pennsylvania, United States, 19140|
|Principal Investigator:||Carol J Homko, RN, PhD||Temple University|