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Gestation Diabetes N'Teractive Media-based Education (GDnME) (GDnME)

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ClinicalTrials.gov Identifier: NCT03947073
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Columbia University

Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE June 12, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
Total number of women who failed management with diet alone [ Time Frame: Up to 42 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03947073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • A1C Level [ Time Frame: Up to 42 weeks ]
    A1C level will be measured at the 24-28 weeks and at approximately 37 weeks or time of delivery (up to 42 weeks).
  • Average fasting blood sugar level [ Time Frame: Up to 42 weeks ]
    Fasting blood sugar level will be measured at first week of entry and at approximately 37 weeks or time of delivery (up to 42 weeks of gestation).
  • Average 2 hour post-prandial blood sugar level [ Time Frame: Up to 42 weeks ]
    The 2-hour post-prandial blood sugar level (after breakfast, lunch, and dinner) will be measured at first week of entry and at approximately 37 weeks or at the time of delivery (up to 42 weeks of gestation).
  • Total insulin requirement [ Time Frame: Up to 42 weeks ]
    Average insulin required will be measured at first week of entry and at approximately 37 weeks or at the time of delivery (up to 42 weeks of gestation).
  • Total metformin requirement [ Time Frame: Up to 42 weeks ]
    Average metformin required will be measured at first week of entry and at delivery (up to 42 weeks of gestation).
  • Total number of women who develop gestational hypertension [ Time Frame: Up to 42 weeks ]
    Gestational hypertension is defined as blood pressures captured after 20 weeks of gestation that are either 140 systolic or 90 diastolic on 2 occasions at least 4 hours apart. This will be collected until delivery which may be up to 42 weeks of gestation.
  • Total number of women who develop pre-eclampsia [ Time Frame: Up to 42 weeks ]
    Pre-eclampsia is defined as blood pressures of 140 systolic or 90 diastolic on 2 occasions at least 4 hours apart during the gestation plus either neurologic/hepatic/or end organ dysfunction or proteinuria defined as protein:creatinine ratio of >0.3 or 24 hr urine protein of over 300 mg/24 hours. This will be collected until delivery which may be up to 42 weeks of gestation.
  • C-section rate [ Time Frame: Up to 42 weeks ]
    Total number of women who have a c-section of the total number of deliveries. This will be collected until delivery which may be up to 42 weeks of gestation.
  • Difference in weight [ Time Frame: Up to 42 weeks ]
    Weight difference from the time of diagnosis compared to weight at delivery will be measured. This will be collected until delivery which may be up to 42 weeks of gestation.
  • Total number of neonates with shoulder dystocia [ Time Frame: Up to 42 weeks ]
    Complication during delivery when an infants shoulder's get lodged in the mother's pelvis, requiring special maneuvers in order to dislodge the shoulder. This will be collected until delivery which may be up to 42 weeks of gestation.
  • Total number of neonates with a NICU admission [ Time Frame: Up to postpartum day 7 ]
    Measures admission to the neonatal intensive care unit within 2 weeks of birth. This information will be collected until postpartum day 7.
  • Total number of neonates with neonatal hypoglycemia [ Time Frame: Up to postpartum day 7 ]
    Measures plasma glucose level of less than 30 mg/dL (1.65 mmol/L) in the first 24 hours of life and less than 45 mg/dL (2.5 mmol/L) thereafter
  • Total number of neonates with neonatal respiratory distress syndrome [ Time Frame: Up to postpartum day 7 ]
    Clinical diagnosis made by neonatologist/pediatrician: Symptoms and signs of RDS include rapid, labored, grunting respirations appearing immediately or within a few hours after delivery, with suprasternal and substernal retractions and flaring of the nasal alae. As atelectasis and respiratory failure progress, symptoms worsen, with cyanosis, lethargy, irregular breathing, and apnea. Diagnosis of RDS is by clinical presentation, including recognition of risk factors; ABGs showing hypoxemia and hypercapnia; and chest x-ray. Chest x-ray shows diffuse atelectasis classically described as having a ground-glass appearance with visible air bronchograms; appearance correlates loosely with clinical severity.
  • Total number of neonates with jaundice [ Time Frame: Up to postpartum day 7 ]
    The total number of neonates needing phototherapy to treat jaundice will be measured.
  • Total number of neonates with an Apgar score <7 [ Time Frame: Up to 42 weeks ]
    The total number of neonates with an Apgar score of <7 at 5 minutes from birth will be measured. This information will be collected until delivery which may be up to 42 weeks of gestation.
  • Total number of neonates with a preterm birth [ Time Frame: Up to 36 weeks and 6 days of gestation ]
    The total number of neonates with birth with a gestational period of less than 37 weeks (iatrogenic and spontaneous) will be measured.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gestation Diabetes N'Teractive Media-based Education (GDnME)
Official Title  ICMJE Gestation Diabetes N'Teractive Media-based Education (GDnME) Trial
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.
Detailed Description Gestational diabetes is a condition diagnosed during pregnancy that causes blood sugars to rise. Diet and exercise can effectively control blood sugar levels in 70-85% of women diagnosed with gestational diabetes according to the American Diabetes Association. At the investigator's institution, only 50-54% of women with this diagnosis effectively reach the target blood sugar levels with diet and exercise alone. This has become a more commonly seen problem throughout the US. Those that fail to achieve target blood sugar levels require medication and have higher risks of poor maternal and neonatal outcomes. Studies have shown that an increase in education can increase compliance to diet and education. Specifically, media based education that are interactive may more effectively lead to changes in a person's behavior.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Gestational Diabetes
Intervention  ICMJE Other: Education
Three cartoon illustrated educational videos with information on gestational diabetes will be provided to the patient in addition to standard of care.
Study Arms  ICMJE
  • No Intervention: Standard of Care
    Subjects with newly diagnosed gestational diabetes are randomized to standard of care diabetes education.
  • Experimental: Interactive Educational Application
    Subjects with newly diagnosed gestational diabetes are randomized to standard of care plus an interactive educational application.
    Intervention: Other: Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Diagnosed with a fetal anomaly
  • Have multiple gestation
  • Known diagnosis of pregestational diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roxane C Handal-Orefice, MD, MPH 6176423675 rh2842@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03947073
Other Study ID Numbers  ICMJE AAAR9927
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (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.
Responsible Party Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Noelia Zork, MD Columbia University
PRS Account Columbia University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP