GPT-based Counseling for Gestational Diabetes

(AIM-GDM Trial)

Recruiting at 1 trial location

Overseen By Avish Arora, MD/PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Pre-existing diabetes, High-risk pregnancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Throughout pregnancy until delivery

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an AI-based counseling service can help manage gestational diabetes, a type of diabetes that occurs during pregnancy. Participants will receive either regular nutritional counseling or the same counseling with added AI support, known as GPT-based Nutrition and Diabetic Counseling. The trial aims to determine if the AI can make managing gestational diabetes easier and more effective. Pregnant women diagnosed with gestational diabetes who can use a smartphone and speak English or Spanish are well-suited for this study. As an unphased study, this trial provides a unique opportunity to explore innovative AI support in managing gestational diabetes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this AI-based counseling service is safe for managing gestational diabetes?

Research has shown that using AI, such as GPT-based counseling, for managing gestational diabetes is generally safe and well-received. Studies have found that AI can assist in managing diabetes by identifying issues like high blood pressure and high cholesterol, which can increase diabetes risk. Importantly, these studies did not report any serious side effects from using AI in diabetes care.

This suggests that using AI for nutrition and diabetes counseling, as in this trial, is likely safe. Since the trial does not involve testing a new drug or any invasive procedures, the risk of negative effects remains low. Participants can feel assured that the AI-based approach is safe and may help improve blood sugar control during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about GPT-based counseling for gestational diabetes because it leverages artificial intelligence to provide personalized nutrition and diabetes management advice. Unlike traditional methods that rely heavily on face-to-face interactions with healthcare providers, this approach uses AI to deliver tailored guidance, potentially making it more accessible and convenient for expectant mothers. Additionally, it offers the possibility of real-time adjustments to dietary and lifestyle recommendations, which could improve blood sugar control more effectively than current standard care options.

What evidence suggests that GPT-based counseling is effective for gestational diabetes?

This trial will compare GPT-based Nutrition and Diabetic Counseling with standard Nutritional Counseling for managing gestational diabetes. Research has shown that AI-driven diet advice can effectively manage diabetes by maintaining normal blood sugar levels. This guidance could reduce risks for both mothers and babies during pregnancy. In a past study, AI-based advice improved blood sugar control in pregnant women with diabetes. Additionally, AI tools have successfully educated individuals on managing type 2 diabetes. These findings suggest that AI, such as GPT, might enhance diabetes management during pregnancy by providing improved diet and lifestyle tips. ^{1 2 3 4 6}

Who Is on the Research Team?

Dimitrios Mastrogiannis, MD

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for women aged 18-45 who have been diagnosed with gestational diabetes during pregnancy. Participants must be able to use a smartphone and speak English or Spanish fluently.

Inclusion Criteria

I am a woman aged between 18 and 45.

Diagnosed with GDM in pregnancy

Able to use a smartphone

Exclusion Criteria

High-risk pregnancies due to other medical conditions

No smartphone access

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nutritional counseling with or without AI intervention for gestational diabetes management

Throughout pregnancy until delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks post-delivery

What Are the Treatments Tested in This Trial?

Interventions

• GPT-based Nutrition and Diabetic Counseling

Trial Overview The AIM-GDM trial is testing if AI-based counseling, alongside nutritional advice, helps manage gestational diabetes better than current standard care practices.

How Is the Trial Designed?

Group I: Nutritional Counseling plus AI Intervention Experimental Treatment 2 Interventions

Group II: Nutritional Counseling Active Control 1 Intervention

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Published Research Related to This Trial

A study involving 180 gestational diabetes mellitus (GDM) patients showed that interdisciplinary health education combined with personalized nutrition significantly reduced fasting blood glucose (FPG), two-hour postprandial glucose (2hPBG), and glycated hemoglobin (HbA1C) levels compared to routine care.

The intervention also led to improved psychological scores (SDS and SAS) after treatment, indicating better overall management of GDM, although the difference in pregnancy outcomes between the two groups was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of interdisciplinary and diversified health education combined with personalized nutrition intervention on FPG, 2hPG, SDS, SAS scores and the pregnancy outcomes of gestational diabetes mellitus. Zhu, GH., Xu, Y., Zou, L., et al.[2021]

A clinical trial involving 215 women with gestational diabetes showed that following specific nutrition practice guidelines led to less insulin use and better control of glycated hemoglobin levels in diabetes clinic settings compared to usual care.

Women receiving care under the nutrition practice guidelines had a lower proportion of elevated glycated hemoglobin levels (8.1%) compared to those in the usual care group (13.6%), suggesting that these guidelines may improve management of gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of gestational diabetes mellitus nutrition practice guidelines implemented by registered dietitians on pregnancy outcomes. Reader, D., Splett, P., Gunderson, EP.[2022]

Medical nutrition therapy is essential for managing gestational diabetes mellitus (GDM), focusing on meeting the nutritional needs of both mother and fetus while maintaining optimal blood sugar levels.

Current guidelines recommend a balanced diet for women with GDM, but there is still debate over the best dietary compositions and weight management strategies, highlighting the need for further research to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gestational diabetes and nutritional recommendations. Gunderson, EP.[2019]

Nutrition therapy is essential for managing gestational diabetes mellitus (GDM), and guidelines have been developed by leading organizations to provide evidence-based recommendations for pregnant women with GDM.

While it is recognized that nutrition needs during pregnancy are similar for women with and without diabetes, there is still limited evidence supporting specific nutrition practices for GDM, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for nutrition best practice in the management of gestational diabetes mellitus. Executive summary (1). [2007]

A 12-week randomized controlled trial with 38 women showed that dietary counseling focusing on whole berries and leafy vegetables significantly improved metabolic health in those with gestational diabetes mellitus (GDM), including better blood glucose levels and increased antioxidant capacity.

The study suggests that incorporating specific functional foods, like berries and leafy vegetables, into the diet can effectively manage GDM and should be recommended as part of treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Eating Pattern Including Colorful Fruits and Vegetables on Management of Gestational Diabetes: A Randomized Controlled Trial. Jaworsky, K., DeVillez, P., Alexander, JM., et al.[2023]

The implementation of a structured model of care for gestational diabetes in regional Australian sites significantly increased the proportion of women receiving best practice nutrition therapy from 3.5% to 87.8% at Site 1, demonstrating the efficacy of the approach.

Despite challenges such as organizational barriers, the project successfully reduced the number of women requiring medication for gestational diabetes, indicating improved management of the condition through enhanced support and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically relevant improvements achieved from a facilitated implementation of a gestational diabetes model of care. Wilkinson, SA., McCray, SJ., Kempe, A., et al.[2019]

Citations

1. trialx.com trialx.com/clinical-trials/listings/294444/evaluating-the-efficacy-of-gpt-based-nutrition-and-diabetic-counseling-in-gestational-diabetes-management-a-randomized-controlled-trial-aim-gdm/?&radius=50

A Randomized Controlled Trial (AIM-GDM) Clinical trial for Gestational Diabetes , Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes ...

2. trials-api.montefioreeinstein.org trials-api.montefioreeinstein.org/node/413271

A Randomized Controlled Trial (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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10591058/

Artificial intelligence in diabetes management - PubMed Central AI-based diet recommendations​​ A proper diet is indispensable in managing diabetic patients by maintaining normal blood sugar levels and reducing the burden of ...

4. app.trialscreen.org app.trialscreen.org/trials/evaluating-efficacy-gpt-based-nutrition-diabetic-counseling-gestational-trial-nct06582719

A Randomized Controlled Trial (AIM-GDM) Potential benefits of participating in this study include improved blood sugar control during pregnancy, which can reduce risks to both the mother and baby.

5. jmir.org jmir.org/2025/1/e70131

The Effectiveness of a Custom AI Chatbot for Type 2 ... This study aimed to evaluate the effectiveness of a custom RAG-based artificial intelligence chatbot designed to improve health literacy on type 2 diabetes ...

6. arxiv.org arxiv.org/pdf/2509.21450

LLM-Based Support for Diabetes Diagnosis This experiment investigates GPT-5's ability to interpret oral glucose tolerance test. (OGTT) results for gestational diabetes mellitus (GDM).