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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:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01030744
First received: November 30, 2009
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 49 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030744

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

No publications provided

Responsible Party: Tom A. Elasy, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01030744     History of Changes
Other Study ID Numbers: GDM Elasy
Study First Received: November 30, 2009
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013