Gestational DiabetesGDnMENCT03947073
Gestation Diabetes N'Teractive Media-based Education (GDnME)
A study testing Education in people with Gestational Diabetes, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2019to 27 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Diagnosed with a fetal anomaly
- Have multiple gestation
- Known diagnosis of pregestational diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Education
- Keywords
- Media, Education, Gestational diabetes, Pregnancy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Three cartoon illustrated educational videos with information on gestational diabetes will be provided to the patient in addition to standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Subjects with newly diagnosed gestational diabetes are randomized to standard of care diabetes education. |
| Interactive Educational Application | Experimental | Subjects with newly diagnosed gestational diabetes are randomized to standard of care plus an interactive educational application. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 42 weeks
Secondary outcomes (16)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to postpartum day 7
Total number of neonates with jaundice
The total number of neonates needing phototherapy to treat jaundice will be measured.
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.
Measured: 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.
Measured: Up to 36 weeks and 6 days of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start12 Jun 2019
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noelia Zork, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947073
- Sponsor's protocol ID
- AAAR9927
- Acronym
- GDnME
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2019
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestation Diabetes N'Teractive Media-based Education (GDnME) Trial
- ClinicalTrials.gov ID
- NCT03947073
- Acronym / sponsor ID
- GDnME / AAAR9927
- Conditions
- Gestational Diabetes
- Keywords
- Media, Education, Gestational diabetes, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Subjects with newly diagnosed gestational diabetes are randomized to standard of care diabetes education. |
| Interactive Educational Application | Experimental | Other: EducationSubjects with newly diagnosed gestational diabetes are randomized to standard of care plus an interactive educational application. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Diagnosed with a fetal anomaly
- Have multiple gestation
- Known diagnosis of pregestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationThree cartoon illustrated educational videos with information on gestational diabetes will be provided to the patient in addition to standard of care. | Other | Interactive Educational Application |
Primary outcome
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.
16 secondary outcomes
A1C Level
Time frame: Up to 42 weeks
Average fasting blood sugar level
Time frame: Up to 42 weeks
Average 2 hour post-prandial blood sugar level
Time frame: Up to 42 weeks
Total insulin requirement
Time frame: Up to 42 weeks
Total metformin requirement
Time frame: Up to 42 weeks
Total number of women who develop gestational hypertension
Time frame: Up to 42 weeks
Total number of women who develop pre-eclampsia
Time frame: Up to 42 weeks
C-section rate
Time frame: Up to 42 weeks
Difference in weight
Time frame: Up to 42 weeks
Total number of neonates with shoulder dystocia
Time frame: Up to 42 weeks
Total number of neonates with a NICU admission
Time frame: Up to postpartum day 7
Total number of neonates with neonatal hypoglycemia
Time frame: Up to postpartum day 7
Total number of neonates with neonatal respiratory distress syndrome
Time frame: Up to postpartum day 7
Total number of neonates with jaundice
Time frame: Up to postpartum day 7
Total number of neonates with an Apgar score <7
Time frame: Up to 42 weeks
Total number of neonates with a preterm birth
Time frame: Up to 36 weeks and 6 days of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: Yes. yes
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noelia Zork, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Gestational Diabetes, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of women who failed management with diet alone (time frame: Up to 42 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.