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Improving Outcomes in Underserved Women With GDM

Improving Outcomes in Underserved Women With GDM

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00774124
Enrollment
57
Registered
2008-10-17
Start date
2007-08-31
Completion date
2010-07-31
Last updated
2017-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Pregnancy

Keywords

GDM, pregnancy, macrosomia

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.

Interventions

OTHERtelemonitoring

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

OTHERStandard 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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* diagnosis of GDM * 33 or less weeks gestation

Exclusion criteria

* multiple gestations * history of glucose intolerance outside of pregnancy

Design outcomes

Primary

MeasureTime frame
maternal blood glucose control3 to 9 months

Secondary

MeasureTime frame
infant birthweightat delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026