Gestational DiabetesGDM ElasyNCT01030744
Evaluation of the Gestational Diabetes Self-Management Education Program and Quality Improvement Plan
An observational study of Gestational Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Refusal of consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University : Vanderbilt Diabetes Center (VDC)
Nashville, Tennessee, 37237-8148
About this study
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.
- Conditions
- Gestational Diabetes
- Keywords
- Gestational Diabetes, Self-Monitoring of Blood Glucose
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Monitoring of Blood Glucose
Measured: chart review quarterly during course of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: This is quality improvement review and should not have been registered. No participants were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030744
- Sponsor's protocol ID
- GDM Elasy
- Acronym
- GDM Elasy
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2009
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Gestational Diabetes Self-Management Education Program and Quality Improvement Plan
- ClinicalTrials.gov ID
- NCT01030744
- Acronym / sponsor ID
- GDM Elasy / GDM Elasy
- Conditions
- Gestational Diabetes
- Keywords
- Gestational Diabetes, Self-Monitoring of Blood Glucose
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This is quality improvement review and should not have been registered. No participants were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Refusal of consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-Monitoring of Blood Glucose
Time frame: chart review quarterly during course of study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Monitoring of Blood Glucose (time frame: chart review quarterly during course of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.