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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT06582719
Status
Recruiting
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Conditions

  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • GPT-based counseling — DEVICE
    AI-based counseling provided to the patient, accessible on their smartphone device at the time of Gestational Diabetes diagnosis
  • Nutritional Counseling — OTHER
    Standard Nutritional Counselling provided by a registered dietician at the time of Gestational Diabetes diagnosis

Study Details

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.

Key Dates

Start date
May 29, 2025
Status verified
Jun 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nutritional Counseling plus AI Intervention
  • Active Comparator: Nutritional Counseling

Primary Outcome Measure

Birth weight at time of Delivery [ Time Frame: Within 12 hours of delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10461
Dimitrios Mastrogiannis, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Montefiore Medical Center· The Bronx, NY

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