Improving Outcomes in Underserved Women With GDM
2 other identifiers
interventional
57
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Aug 2007
Typical duration for not_applicable diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 16, 2008
CompletedFirst Posted
Study publicly available on registry
October 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedOctober 20, 2017
October 1, 2017
2.9 years
October 16, 2008
October 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
maternal blood glucose control
3 to 9 months
Secondary Outcomes (1)
infant birthweight
at delivery
Study Arms (2)
1 Telemedicine
EXPERIMENTALUsual care plus telemonitoring
2 Standard of Care
ACTIVE COMPARATORStandard of care - women will monitor and record blood glucose levels four times a day.
Interventions
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
Health data (blood glucose levels and insulin doses) will be recorded in a paper log book which will be reviewed at prenatal visits.
Eligibility Criteria
You may qualify if:
- diagnosis of GDM
- or less weeks gestation
You may not qualify if:
- multiple gestations
- history of glucose intolerance outside of pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Temple Universitylead
- National Institutes of Health (NIH)collaborator
Study Sites (2)
Tallahassee Memorial Diabetes Center
Tallahassee, Florida, 32308, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Related 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. doi: 10.1089/dia.2006.0034.
PMID: 17561800BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carol J Homko, RN, PhD
Temple University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2008
First Posted
October 17, 2008
Study Start
August 1, 2007
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
October 20, 2017
Record last verified: 2017-10