Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes Management: A Randomized Controlled Trial (AIM-GDM)
AIM-GDM
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2024
CompletedFirst Posted
Study publicly available on registry
September 3, 2024
CompletedStudy Start
First participant enrolled
May 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
June 13, 2025
June 1, 2025
1.6 years
August 30, 2024
June 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Rate of Neonatal Intensive Care Unit (NICU) admissions
Within 12 hours of delivery
Rate of Cesarean Section
Within 12 hours of delivery
Rate of Progression to medication requirements
At the time of delivery
Rate of Shoulder Dystocia
Within 12 hours of delivery
Study Arms (2)
Nutritional Counseling plus AI Intervention
EXPERIMENTALNutritional Counseling
ACTIVE COMPARATORInterventions
AI-based counseling provided to the patient, accessible on their smartphone device at the time of Gestational Diabetes diagnosis
Standard Nutritional Counselling provided by a registered dietician at the time of Gestational Diabetes diagnosis
Eligibility Criteria
You may qualify if:
- Women aged 18-45
- Diagnosed with GDM in pregnancy
- Able to use a smartphone
- Fluent in English or Spanish
You may not qualify if:
- Pre-existing diabetes
- High-risk pregnancies due to other medical conditions
- Inability to consent
- Non-English and/or Non-Spanish speakers
- No smartphone access
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10461, United States
Related Publications (2)
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.
PMID: 8559516BACKGROUNDCenters for Disease Control and Prevention (CDC). (2022). National Diabetes Statistics Report
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dimitrios Mastrogiannis, MD
Albert Einstein College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2024
First Posted
September 3, 2024
Study Start
May 29, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share