GPT-based nutrition and diabetes counseling for pregnant people with gestational diabetes
Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes Management: A Randomized Controlled Trial (AIM-GDM)
This trial will test whether an AI (GPT)-based counseling app plus nutritional counseling helps pregnant people with gestational diabetes manage blood sugar and feel more supported.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06582719 on ClinicalTrials.gov |
What this trial studies
In a randomized controlled design at Montefiore Medical Center, pregnant participants diagnosed with gestational diabetes will be assigned to receive GPT-based, smartphone-delivered counseling alongside standard nutritional counseling or to receive standard nutritional counseling alone. The intervention offers real-time, personalized dietary and diabetes-management guidance in English or Spanish. Primary outcomes include measures of glycemic control and patient-reported satisfaction and engagement during pregnancy. The trial targets adults aged 18–45 who can use a smartphone and excludes those with pre-existing diabetes or other high-risk pregnancy conditions.
Who should consider this trial
Good fit: Ideal candidates are pregnant people aged 18–45 diagnosed with gestational diabetes who have a smartphone and can use English or Spanish-language apps, without pre-existing diabetes or other high-risk pregnancy conditions.
Not a fit: People with pre-existing diabetes, those with high-risk pregnancies for other medical reasons, individuals who cannot consent, and those without smartphone access or who do not speak English or Spanish are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could provide scalable, personalized support that improves blood-sugar control and patient experience during pregnancy.
How similar studies have performed: Previous digital health and AI coaching programs have improved engagement and some glycemic outcomes, but GPT-specific counseling for gestational diabetes is largely novel and not yet validated in large trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Dimitrios Mastrogiannis, MD — Albert Einstein College of Medicine
- Study coordinator: Avish Arora, MD/PhD
- Email: avarora@montefiore.org
- Phone: 7184058200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.