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

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: Education

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: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1C Level	A1C level will be measured at the 24-28 weeks and at approximately 37 weeks or time of delivery (up to 42 weeks).	Up to 42 weeks
Average fasting blood sugar level	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).	Up to 42 weeks
Average 2 hour post-prandial blood sugar level	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).	Up to 42 weeks
Total insulin requirement	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).	Up to 42 weeks
Total metformin requirement	Average metformin required will be measured at first week of entry and at delivery (up to 42 weeks of gestation).	Up to 42 weeks
Total number of women who develop gestational hypertension	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.	Up to 42 weeks
Total number of women who develop pre-eclampsia	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.	Up to 42 weeks
C-section rate	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.	Up to 42 weeks
Difference in weight	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.	Up to 42 weeks
Total number of neonates with shoulder dystocia	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.	Up to 42 weeks
Total number of neonates with a NICU admission	Measures admission to the neonatal intensive care unit within 2 weeks of birth. This information will be collected until postpartum day 7.	Up to postpartum day 7
Total number of neonates with neonatal hypoglycemia	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	Up to postpartum day 7
Total number of neonates with neonatal respiratory distress syndrome	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.	Up to postpartum day 7
Total number of neonates with jaundice	The total number of neonates needing phototherapy to treat jaundice will be measured.	Up to postpartum day 7
Total number of neonates with an Apgar score <7	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.	Up to 42 weeks
Total number of neonates with a preterm birth	The total number of neonates with birth with a gestational period of less than 37 weeks (iatrogenic and spontaneous) will be measured.	Up to 36 weeks and 6 days of gestation

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Noelia Zork, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Actual): January 27, 2021
• Study Completion (Actual): January 27, 2021

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy; Education; Gestational diabetes; Media
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: AAAR9927

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: yes
• IPD Sharing Time Frame: At the time of study completion
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No