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

• ClinicalTrials.gov Identifier: NCT03947073
• Recruitment Status: Completed
• First Posted: May 13, 2019
• Last Update Posted: March 19, 2021
• Sponsor: Columbia University
• Information provided by (Responsible Party): Columbia University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gestational Diabetes	Other: Education	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 199 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Gestation Diabetes N'Teractive Media-based Education (GDnME) Trial
• Actual Study Start Date: June 12, 2019
• Actual Primary Completion Date: January 27, 2021
• Actual Study Completion Date: January 27, 2021

Arms and Interventions

Arm	Intervention/treatment
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.	Other: Education; Three cartoon illustrated educational videos with information on gestational diabetes will be provided to the patient in addition to standard of care.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).
2. 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).
3. 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).
4. 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).
5. 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).
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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
13. 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.
14. 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.
15. 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.
16. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New York

Columbia University Irving Medical Center

New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

• Principal Investigator: Noelia Zork, MD; Columbia University

More Information

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT03947073
• Other Study ID Numbers: AAAR9927
• First Posted: May 13, 2019
• Last Update Posted: March 19, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: yes
• Supporting Materials: Study Protocol; 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Columbia University:

Media; Education; Gestational diabetes; Pregnancy

Additional relevant MeSH terms:

Diabetes, Gestational; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications