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Improving Outcomes in Underserved Women With GDM

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Temple University

Status

Completed

Conditions

Diabetes Mellitus
Pregnancy

Treatments

Other: Standard of care
Other: telemonitoring

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00774124
071694
1R21DK071694 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • diagnosis of GDM
  • 33 or less weeks gestation

Exclusion criteria

  • multiple gestations
  • history of glucose intolerance outside of pregnancy

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

57 participants in 2 patient groups

1 Telemedicine
Experimental group
Description:
Usual care plus telemonitoring
Treatment:
Other: telemonitoring
2 Standard of Care
Active Comparator group
Description:
Standard of care - women will monitor and record blood glucose levels four times a day.
Treatment:
Other: Standard of care

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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