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Evaluation of the Gestational Diabetes Self-Management Education Program and Quality Improvement Plan (GDM Elasy)

This study has been terminated.
(This is quality improvement review and should not have been registered.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01030744
First Posted: December 11, 2009
Last Update Posted: July 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vanderbilt University
  Purpose
The broad, long-term objectives are to generate and test hypotheses leading to theories that guide improved care of patients with gestational diabetes. The purpose of this chart review study is to evaluate the Vanderbilt Gestational Diabetes Self-Management Education Program and Quality Improvement Plan in optimizing metabolic control and improving health outcomes during pregnancy with gestational diabetes.

Condition
Gestational Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Gestational Diabetes Self-Management Education Program and Quality Improvement Plan

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Self-Monitoring of Blood Glucose [ Time Frame: chart review quarterly during course of study ]

Estimated Enrollment: 1200
Study Start Date: December 2015
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gestational Diabetes
Women with gestational diabetes who are referred to and followed in the Vanderbilt Eskind Diabetes Clinic and are participants in the gestational diabetes educational program.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with gestational diabetes who are referred to and followed in the Vanderbilt Eskind Diabetes Clinic and are participants in the gestational diabetes educational program.
Criteria

Inclusion Criteria:

  • Women with gestational diabetes who are referred to and followed in the Vanderbilt Eskind Diabetes Clinic and are participants in the gestational diabetes educational program.

Exclusion Criteria:

  • Refusal of consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030744


Locations
United States, Tennessee
Vanderbilt University : Vanderbilt Diabetes Center (VDC)
Nashville, Tennessee, United States, 37237-8148
Sponsors and Collaborators
Vanderbilt University
  More Information

Responsible Party: Tom A. Elasy, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01030744     History of Changes
Other Study ID Numbers: GDM Elasy
First Submitted: November 30, 2009
First Posted: December 11, 2009
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Vanderbilt University:
Gestational Diabetes
Self-Monitoring of Blood Glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications