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

Primary Purpose

Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gestational Diabetes focused on measuring Media, Education, Gestational diabetes, Pregnancy

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Interactive Educational Application

Arm Description

Subjects with newly diagnosed gestational diabetes are randomized to standard of care diabetes education.

Subjects with newly diagnosed gestational diabetes are randomized to standard of care plus an interactive educational application.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).
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).
Total metformin requirement
Average metformin required will be measured at first week of entry and at delivery (up to 42 weeks of gestation).
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.
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.
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.
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.
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.
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.
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
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.
Total number of neonates with jaundice
The total number of neonates needing phototherapy to treat jaundice will be measured.
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.
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.

Full Information

First Posted
February 25, 2019
Last Updated
March 18, 2021
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03947073
Brief Title
Gestation Diabetes N'Teractive Media-based Education (GDnME)
Acronym
GDnME
Official Title
Gestation Diabetes N'Teractive Media-based Education (GDnME) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
January 27, 2021 (Actual)
Study Completion Date
January 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Media, Education, Gestational diabetes, Pregnancy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Subjects with newly diagnosed gestational diabetes are randomized to standard of care diabetes education.
Arm Title
Interactive Educational Application
Arm Type
Experimental
Arm Description
Subjects with newly diagnosed gestational diabetes are randomized to standard of care plus an interactive educational application.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Three cartoon illustrated educational videos with information on gestational diabetes will be provided to the patient in addition to standard of care.
Primary Outcome Measure Information:
Title
Total number of women who failed management with diet alone
Description
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.
Time Frame
Up to 42 weeks
Secondary Outcome Measure Information:
Title
A1C Level
Description
A1C level will be measured at the 24-28 weeks and at approximately 37 weeks or time of delivery (up to 42 weeks).
Time Frame
Up to 42 weeks
Title
Average fasting blood sugar level
Description
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).
Time Frame
Up to 42 weeks
Title
Average 2 hour post-prandial blood sugar level
Description
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).
Time Frame
Up to 42 weeks
Title
Total insulin requirement
Description
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).
Time Frame
Up to 42 weeks
Title
Total metformin requirement
Description
Average metformin required will be measured at first week of entry and at delivery (up to 42 weeks of gestation).
Time Frame
Up to 42 weeks
Title
Total number of women who develop gestational hypertension
Description
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.
Time Frame
Up to 42 weeks
Title
Total number of women who develop pre-eclampsia
Description
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.
Time Frame
Up to 42 weeks
Title
C-section rate
Description
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.
Time Frame
Up to 42 weeks
Title
Difference in weight
Description
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.
Time Frame
Up to 42 weeks
Title
Total number of neonates with shoulder dystocia
Description
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.
Time Frame
Up to 42 weeks
Title
Total number of neonates with a NICU admission
Description
Measures admission to the neonatal intensive care unit within 2 weeks of birth. This information will be collected until postpartum day 7.
Time Frame
Up to postpartum day 7
Title
Total number of neonates with neonatal hypoglycemia
Description
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
Time Frame
Up to postpartum day 7
Title
Total number of neonates with neonatal respiratory distress syndrome
Description
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.
Time Frame
Up to postpartum day 7
Title
Total number of neonates with jaundice
Description
The total number of neonates needing phototherapy to treat jaundice will be measured.
Time Frame
Up to postpartum day 7
Title
Total number of neonates with an Apgar score <7
Description
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.
Time Frame
Up to 42 weeks
Title
Total number of neonates with a preterm birth
Description
The total number of neonates with birth with a gestational period of less than 37 weeks (iatrogenic and spontaneous) will be measured.
Time Frame
Up to 36 weeks and 6 days of gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noelia Zork, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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