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Improving Outcomes in Underserved Women With GDM

NCT ID: NCT00774124

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Pregnancy

Keywords

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GDM, pregnancy, macrosomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1 Telemedicine

Usual care plus telemonitoring

Group Type EXPERIMENTAL

telemonitoring

Intervention Type OTHER

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

2 Standard of Care

Standard of care - women will monitor and record blood glucose levels four times a day.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Health data (blood glucose levels and insulin doses) will be recorded in a paper log book which will be reviewed at prenatal visits.

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis of GDM
* 33 or less weeks gestation

Exclusion Criteria

* multiple gestations
* history of glucose intolerance outside of pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carol J Homko, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Tallahassee Memorial Diabetes Center

Tallahassee, Florida, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17561800 (View on PubMed)

Other Identifiers

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1R21DK071694

Identifier Type: NIH

Identifier Source: secondary_id

View Link

071694

Identifier Type: -

Identifier Source: org_study_id