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SuspendedNo phase

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

Key facts

Who runs it
Montefiore Medical Center
Where
The Bronx, United StatesSee the site
Trial code
Status
Suspended
People taking part
80 people, planned
Started
29 May 2025
Expected to end
Jan 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • GPT-based counseling
  • Nutritional Counseling
Record updated
12 June 2026
Why it stopped
IRB approval has lapsed, PI has left the institution. PI change planned

Who can take part

Age
18 years to 45 years
Sex
Women only
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

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

Who cannot take part

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

Where in United States

  • Montefiore Medical CenterThe Bronx, United States

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Nutritional Counseling plus AI InterventionTreatment being tested

    Treatment: GPT-based counseling and Nutritional Counseling

  • Nutritional CounselingExisting treatment, for comparison

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
12 June 2026