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

Not Applicable

Completed

• Conditions: Gestational Diabetes
• Interventions: Other: Education

• Registration Number: NCT03947073
• Lead Sponsor: Columbia University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-13
• Study Start: 2019-06-12
• Primary Completion: 2021-01-27
• Study Completion: 2021-01-27
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 199

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.

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Exclusion Criteria

• Diagnosed with a fetal anomaly
• Have multiple gestation
• Known diagnosis of pregestational diabetes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interactive Educational Application	Education	Subjects with newly diagnosed gestational diabetes are randomized to standard of care plus an interactive educational application.

Primary Outcome Measures

Name	Time	Method
Total number of women who failed management with diet alone	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

Name	Time	Method
Average 2 hour post-prandial blood sugar level	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	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 number of women who develop gestational hypertension	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	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.
Total number of neonates with neonatal hypoglycemia	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 jaundice	Up to postpartum day 7	The total number of neonates needing phototherapy to treat jaundice will be measured.
Average fasting blood sugar level	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).
Difference in weight	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 neonatal respiratory distress syndrome	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 metformin requirement	Up to 42 weeks	Average metformin required will be measured at first week of entry and at delivery (up to 42 weeks of gestation).
C-section rate	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.
Total number of neonates with shoulder dystocia	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	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.
A1C Level	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).
Total number of neonates with an Apgar score <7	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	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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States