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Completed

NCT Number: NCT03947073

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Acronym: GDnME

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 13, 2019
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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