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

Gestational Diabetes Clinical Trial

— GDnME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03947073
• Other study ID #: AAAR9927
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: January 27, 2021

Study information

• Verified date: March 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: January 27, 2021
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Total number of neonates with jaundice	The total number of neonates needing phototherapy to treat jaundice will be measured.	Up to postpartum day 7
Secondary	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
Secondary	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