GPT-based Counseling for Gestational Diabetes

(AIM-GDM Trial)

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?

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.

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.

Is GPT-based counseling for gestational diabetes safe for humans?

The research articles provided do not contain specific safety data on GPT-based counseling for gestational diabetes or similar treatments. They focus on dietary interventions and nutrition therapy for managing gestational diabetes, but do not address the safety of GPT-based counseling. ^{1 2 3 4 5}

How is GPT-based Nutrition and Diabetic Counseling different from other treatments for gestational diabetes?

GPT-based Nutrition and Diabetic Counseling is unique because it likely uses advanced AI technology to provide personalized dietary and lifestyle advice, which may offer more tailored support compared to traditional methods like carbohydrate counting or general dietary guidelines. This approach could potentially enhance patient engagement and adherence to dietary recommendations, although specific details about its implementation and effectiveness compared to existing treatments are not provided in the research. ^{1 3 5 6 7}

What data supports the effectiveness of the treatment GPT-based Nutrition and Diabetic Counseling for gestational diabetes?

Research shows that counseling programs and nutrition practice guidelines can improve outcomes for women with gestational diabetes by adapting dietary recommendations to individual needs and cultural backgrounds, leading to better metabolic control and appropriate infant birth weights. ^{4 8 9 10 11}

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 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]

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]

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]

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]

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]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Counseling programs and the outcome of gestational diabetes in Austrian and Mediterranean Turkish women. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of gestational diabetes mellitus nutrition practice guidelines implemented by registered dietitians on pregnancy outcomes. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Gestational diabetes mellitus: an evaluation of gynecologists' knowledge of guidelines and counseling behavior. [2022]

4. Poland 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Gestational diabetes and nutritional recommendations. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of an Eating Pattern Including Colorful Fruits and Vegetables on Management of Gestational Diabetes: A Randomized Controlled Trial. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Can a Simple Dietary Screening in Early Pregnancy Identify Dietary Habits Associated with Gestational Diabetes? [2020]

8. Australia pubmed.ncbi.nlm.nih.gov

Clinically relevant improvements achieved from a facilitated implementation of a gestational diabetes model of care. [2019]

9. Canada pubmed.ncbi.nlm.nih.gov

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

10. Spain pubmed.ncbi.nlm.nih.gov

Systematic review; Nutritional therapy in gestational diabetes mellitus. [2018]

11. Ireland pubmed.ncbi.nlm.nih.gov

Maternal metabolic response to dietary treatment for impaired glucose tolerance and gestational diabetes mellitus. [2018]