Gestational Diabetes
Conditions
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.
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.
Interventions
DEVICEGPT-based counseling
AI-based counseling provided to the patient, accessible on their smartphone device at the time of Gestational Diabetes diagnosis
OTHERNutritional Counseling
Standard Nutritional Counselling provided by a registered dietician at the time of Gestational Diabetes diagnosis
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Birth weight at time of Delivery | Within 12 hours of delivery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Neonatal Intensive Care Unit (NICU) admissions | Within 12 hours of delivery | 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. |
| Rate of Cesarean Section | Within 12 hours of delivery | 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. |
| Rate of Progression to medication requirements | At the time of delivery | 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. |
| Rate of Shoulder Dystocia | Within 12 hours of delivery | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDimitrios Mastrogiannis, MD
Albert Einstein College of Medicine
Outcome results
None listed