Improving Outcomes in Underserved Women With GDM

Not Applicable

Completed

• Conditions: Pregnancy; Diabetes Mellitus
• Interventions: Other: telemonitoring; Other: Standard of care

• Registration Number: NCT00774124
• Lead Sponsor: Temple University

Brief 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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

• diagnosis of GDM
• 33 or less weeks gestation

Exclusion Criteria

• multiple gestations
• history of glucose intolerance outside of pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Telemedicine	telemonitoring	Usual care plus telemonitoring
2 Standard of Care	Standard of care	Standard of care - women will monitor and record blood glucose levels four times a day.

Primary Outcome Measures

Name	Time	Method
maternal blood glucose control	3 to 9 months

Secondary Outcome Measures

Name	Time	Method
infant birthweight	at delivery

Trial Locations

Locations (2)

Tallahassee Memorial Diabetes Center; 🇺🇸 Tallahassee, Florida, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States