Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes Management: A Randomized Controlled Trial (AIM-GDM)

Brief Summary
The purpose of this study is to assess whether an AI based counseling service can be beneficial for patients to assist in management of gestational diabetes.
Brief Title
Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes Management: A Randomized Controlled Trial (AIM-GDM)
Detailed Description
Gestational diabetes mellitus (GDM) affects approximately 6-9% of pregnancies globally, posing significant risks to both maternal and neonatal health. Standard management includes dietary counseling, glucose monitoring, and insulin therapy when necessary. However, the rising prevalence of GDM and limited healthcare resources necessitate innovative solutions to supplement traditional care. Generative Pre-trained Transformers (GPTs), a type of large language model (LLM), offer personalized, real-time counseling and support. Recent advancements in AI have shown promise in various healthcare applications, but the efficacy of GPT-based counseling in GDM management remains underexplored. This study builds on preliminary evidence suggesting that AI can enhance patient engagement and outcomes, aiming to validate these findings in a controlled trial.

The integration of AI, specifically GPTs, into healthcare can revolutionize patient management by providing continuous, tailored support. This study aims to evaluate whether GPT-based counseling can improve glycemic control and patient satisfaction in GDM management, compared to traditional counseling alone. By placing AI within the context of prenatal care, this research seeks to address gaps in current GDM management practices and offer scalable, personalized solutions.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
7184058200
Central Contact Email
avarora@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:

* Women aged 18-45
* Diagnosed with GDM in pregnancy
* Able to use a smartphone
* Fluent in English or Spanish

Exclusion Criteria:

* Pre-existing diabetes
* High-risk pregnancies due to other medical conditions
* Inability to consent
* Non-English and/or Non-Spanish speakers
* No smartphone access
Inclusion Criteria
Inclusion Criteria:

* Women aged 18-45
* Diagnosed with GDM in pregnancy
* Able to use a smartphone
* Fluent in English or Spanish

Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
45 Years
Minimum Age
18 Years
NCT Id
NCT06582719
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2024-16035
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes Management: A Randomized Controlled Trial (AIM-GDM)
Primary Outcomes
Outcome Description
Newborns will be weighed within 12 hours of the time of delivery. Birth weights will be summarized and reported by study group using basic descriptive statistics. Higher birth weights have been associated with Gestational Diabetes Mellitus (GDM) and increased risk of perinatal complications.
Outcome Measure
Birth weight at time of Delivery
Outcome Time Frame
Within 12 hours of delivery
Secondary Outcomes
Outcome Description
Rate of NICU admission will be expressed as the percentage of newborns who were admitted to the NICU within 12 hours of delivery. Rates will be summarized and reported by study group using basic descriptive statistics. Increased admissions to the NICU are associated with less favorable perinatal outcomes.
Outcome Time Frame
Within 12 hours of delivery
Outcome Measure
Rate of Neonatal Intensive Care Unit (NICU) admissions
Outcome Description
Rate of Cesarean Section will be expressed as the percentage of patients who delivered via Cesarean section. Rates will be summarized and reported by study group using basic descriptive statistics. Patients with GDM are more likely to need Cesarean sections leading to less favorable perinatal outcomes for the newborn.
Outcome Time Frame
Within 12 hours of delivery
Outcome Measure
Rate of Cesarean Section
Outcome Description
The rate of progression to medication requirements for GDM will be assessed as the percentage of patients who are administered either insulin or oral hypoglycemic at the time of delivery. Rates will be summarized and reported by study group using basic descriptive statistics. Higher rates of progression to medications are associated with increased hyperglycemia and less favorable perinatal outcomes in general.
Outcome Time Frame
At the time of delivery
Outcome Measure
Rate of Progression to medication requirements
Outcome Description
Rate of Shoulder Dystocia will be expressed as the percentage of patients who have been diagnosed with should dystocia within 12 hours of delivery. Rates will be summarized and reported by study group using basic descriptive statistics. GDM is a risk factor for shoulder dystocia and higher rates of shoulder dystocia are associated with increased perinatal complications.
Outcome Time Frame
Within 12 hours of delivery
Outcome Measure
Rate of Shoulder Dystocia
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
45
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Dimitrios Mastrogiannis
Investigator Email
dmastrogia@montefiore.org