Gestation Diabetes N'Teractive Media-based Education (GDnME)
GDnME
1 other identifier
interventional
199
1 country
1
Brief Summary
This study is a prospective randomized controlled trial. Subjects with newly diagnosed gestational diabetes will be randomized to either standard of care diabetes education versus standard of care plus an interactive educational application.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2019
CompletedFirst Posted
Study publicly available on registry
May 13, 2019
CompletedStudy Start
First participant enrolled
June 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2021
CompletedMarch 19, 2021
March 1, 2021
1.6 years
February 25, 2019
March 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total number of women who failed management with diet alone
This is defined as a patient who is unable to adequately control blood sugars with diet alone and requires medical intervention. This information will be collected until the time of delivery which could be up to 42 weeks of gestation.
Up to 42 weeks
Secondary Outcomes (16)
A1C Level
Up to 42 weeks
Average fasting blood sugar level
Up to 42 weeks
Average 2 hour post-prandial blood sugar level
Up to 42 weeks
Total insulin requirement
Up to 42 weeks
Total metformin requirement
Up to 42 weeks
- +11 more secondary outcomes
Study Arms (2)
Standard of Care
NO INTERVENTIONSubjects with newly diagnosed gestational diabetes are randomized to standard of care diabetes education.
Interactive Educational Application
EXPERIMENTALSubjects with newly diagnosed gestational diabetes are randomized to standard of care plus an interactive educational application.
Interventions
Three cartoon illustrated educational videos with information on gestational diabetes will be provided to the patient in addition to standard of care.
Eligibility Criteria
You may qualify if:
- Obtaining prenatal care in the Ambulatory Care Network (ACN)
- Speaks either English or Spanish
- Newly diagnosed with gestational diabetes between 24-32 weeks
- Will deliver at CUIMC's main institutions, Children's Hospital of New York (CHONY) or the Allen Hospital.
You may not qualify if:
- Diagnosed with a fetal anomaly
- Have multiple gestation
- Known diagnosis of pregestational diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Irving Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Noelia Zork, MD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2019
First Posted
May 13, 2019
Study Start
June 12, 2019
Primary Completion
January 27, 2021
Study Completion
January 27, 2021
Last Updated
March 19, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- At the time of study completion
- Access Criteria
- Only information that is de-identified can be shared. Information will only be available at the end of the study period in the event that a peer review journal requests the information.
yes