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

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.

Study Overview

• Status: Suspended
• Conditions: Gestational Diabetes
• Intervention / Treatment: Device: GPT-based counseling; Other: Nutritional Counseling

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nutritional Counseling	Other: Nutritional Counseling; Standard Nutritional Counselling provided by a registered dietician at the time of Gestational Diabetes diagnosis
Experimental: Nutritional Counseling plus AI Intervention	Device: GPT-based counseling; AI-based counseling provided to the patient, accessible on their smartphone device at the time of Gestational Diabetes diagnosis; Other: Nutritional Counseling; Standard Nutritional Counselling provided by a registered dietician at the time of Gestational Diabetes diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth weight at time 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.	Within 12 hours of delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Neonatal Intensive Care Unit (NICU) admissions	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.	Within 12 hours of delivery
Rate of Cesarean Section	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.	Within 12 hours of delivery
Rate of Progression to medication requirements	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.	At the time of delivery
Rate of Shoulder Dystocia	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.	Within 12 hours of delivery

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Dimitrios Mastrogiannis, MD, Albert Einstein College of Medicine

Publications and helpful links

General Publications

• Alexander GR, Himes JH, Kaufman RB, Mor J, Kogan M. A United States national reference for fetal growth. Obstet Gynecol. 1996 Feb;87(2):163-8. doi: 10.1016/0029-7844(95)00386-X.
• Centers for Disease Control and Prevention (CDC). (2022). National Diabetes Statistics Report

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Nutrition Assessment
• Other Study ID Numbers: 2024-16035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No