Gestational DiabetesAIM-GDMNCT06582719
Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes Management: A Randomized Controlled Trial (AIM-GDM)
A study testing GPT-based counseling and Nutritional Counseling in people with Gestational Diabetes, run by Montefiore Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- GPT-based counseling and Nutritional Counseling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-45
- Diagnosed with GDM in pregnancy
- Able to use a smartphone
- Fluent in English or Spanish
Who cannot join
- Pre-existing diabetes
- High-risk pregnancies due to other medical conditions
- Inability to consent
- Non-English and/or Non-Spanish speakers
- No smartphone access
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10461
About this study
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.
Read the detailed description
Gestational diabetes mellitus (GDM) affects approximately 6-9% of pregnancies globally, posing significant risks to both maternal and neonatal health. Standard management includes dietary counseling, glucose monitoring, and insulin therapy when necessary. However, the rising prevalence of GDM and limited healthcare resources necessitate innovative solutions to supplement traditional care. Generative Pre-trained Transformers (GPTs), a type of large language model (LLM), offer personalized, real-time counseling and support. Recent advancements in AI have shown promise in various healthcare applications, but the efficacy of GPT-based counseling in GDM management remains underexplored. This study builds on preliminary evidence suggesting that AI can enhance patient engagement and outcomes, aiming to validate these findings in a controlled trial.
The integration of AI, specifically GPTs, into healthcare can revolutionize patient management by providing continuous, tailored support. This study aims to evaluate whether GPT-based counseling can improve glycemic control and patient satisfaction in GDM management, compared to traditional counseling alone. By placing AI within the context of prenatal care, this research seeks to address gaps in current GDM management practices and offer scalable, personalized solutions.
- Conditions
- Gestational Diabetes
- Being tested
- GPT-based counseling, Nutritional Counseling
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPT-based counselingDevice
AI-based counseling provided to the patient, accessible on their smartphone device at the time of Gestational Diabetes diagnosis
Nutritional CounselingOther
Standard Nutritional Counselling provided by a registered dietician at the time of Gestational Diabetes diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Counseling plus AI Intervention | Experimental | Not described Receives: Device: GPT-based counseling; Other: Nutritional Counseling |
| Nutritional Counseling | Active comparator | Not described Receives: Other: Nutritional Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight at time of Delivery
Newborns will be weighed within 12 hours of the time of delivery. Birth weights will be summarized and reported by study group using basic descriptive statistics. Higher birth weights have been associated with Gestational Diabetes Mellitus (GDM) and increased risk of perinatal complications.
Measured: Within 12 hours of delivery
Secondary outcomes (4)
Rate of Neonatal Intensive Care Unit (NICU) admissions
Rate of NICU admission will be expressed as the percentage of newborns who were admitted to the NICU within 12 hours of delivery. Rates will be summarized and reported by study group using basic descriptive statistics. Increased admissions to the NICU are associated with less favorable perinatal outcomes.
Measured: Within 12 hours of delivery
Rate of Cesarean Section
Rate of Cesarean Section will be expressed as the percentage of patients who delivered via Cesarean section. Rates will be summarized and reported by study group using basic descriptive statistics. Patients with GDM are more likely to need Cesarean sections leading to less favorable perinatal outcomes for the newborn.
Measured: Within 12 hours of delivery
Rate of Progression to medication requirements
The rate of progression to medication requirements for GDM will be assessed as the percentage of patients who are administered either insulin or oral hypoglycemic at the time of delivery. Rates will be summarized and reported by study group using basic descriptive statistics. Higher rates of progression to medications are associated with increased hyperglycemia and less favorable perinatal outcomes in general.
Measured: At the time of delivery
Rate of Shoulder Dystocia
Rate of Shoulder Dystocia will be expressed as the percentage of patients who have been diagnosed with should dystocia within 12 hours of delivery. Rates will be summarized and reported by study group using basic descriptive statistics. GDM is a risk factor for shoulder dystocia and higher rates of shoulder dystocia are associated with increased perinatal complications.
Measured: Within 12 hours of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start29 May 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Why it stopped: IRB approval has lapsed, PI has left the institution. PI change planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dimitrios Mastrogiannis, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582719
- Sponsor's protocol ID
- 2024-16035
- Acronym
- AIM-GDM
- Status last verified
- Jun 2026
- First submitted
- 30 Aug 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alexander GR, Himes JH, Kaufman RB, Mor J, Kogan M. A United States national reference for fetal growth. Obstet Gynecol. 1996 Feb;87(2):163-8. doi: 10.1016/0029-7844(95)00386-X.
PubMed 8559516Centers for Disease Control and Prevention (CDC). (2022). National Diabetes Statistics Report
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes Management: A Randomized Controlled Trial (AIM-GDM)
- ClinicalTrials.gov ID
- NCT06582719
- Acronym / sponsor ID
- AIM-GDM / 2024-16035
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: IRB approval has lapsed, PI has left the institution. PI change planned
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Gestational diabetes mellitus (GDM) affects approximately 6-9% of pregnancies globally, posing significant risks to both maternal and neonatal health. Standard management includes dietary counseling, glucose monitoring, and insulin therapy when necessary. However, the rising prevalence of GDM and limited healthcare resources necessitate innovative solutions to supplement traditional care. Generative Pre-trained Transformers (GPTs), a type of large language model (LLM), offer personalized, real-time counseling and support. Recent advancements in AI have shown promise in various healthcare applications, but the efficacy of GPT-based counseling in GDM management remains underexplored. This study builds on preliminary evidence suggesting that AI can enhance patient engagement and outcomes, aiming to validate these findings in a controlled trial.
The integration of AI, specifically GPTs, into healthcare can revolutionize patient management by providing continuous, tailored support. This study aims to evaluate whether GPT-based counseling can improve glycemic control and patient satisfaction in GDM management, compared to traditional counseling alone. By placing AI within the context of prenatal care, this research seeks to address gaps in current GDM management practices and offer scalable, personalized solutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Counseling plus AI Intervention | Experimental | Device: GPT-based counseling, Other: Nutritional Counseling |
| Nutritional Counseling | Active comparator | Other: Nutritional Counseling |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-45
- Diagnosed with GDM in pregnancy
- Able to use a smartphone
- Fluent in English or Spanish
Key exclusion criteria (5 listed)
- Pre-existing diabetes
- High-risk pregnancies due to other medical conditions
- Inability to consent
- Non-English and/or Non-Spanish speakers
- No smartphone access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPT-based counselingAI-based counseling provided to the patient, accessible on their smartphone device at the time of Gestational Diabetes diagnosis | Device | Nutritional Counseling plus AI Intervention |
| Nutritional CounselingStandard Nutritional Counselling provided by a registered dietician at the time of Gestational Diabetes diagnosis | Other | Nutritional Counseling, Nutritional Counseling plus AI Intervention |
Primary outcome
Birth weight at time of Delivery
Time frame: Within 12 hours of delivery
Newborns will be weighed within 12 hours of the time of delivery. Birth weights will be summarized and reported by study group using basic descriptive statistics. Higher birth weights have been associated with Gestational Diabetes Mellitus (GDM) and increased risk of perinatal complications.
4 secondary outcomes
Rate of Neonatal Intensive Care Unit (NICU) admissions
Time frame: Within 12 hours of delivery
Rate of Cesarean Section
Time frame: Within 12 hours of delivery
Rate of Progression to medication requirements
Time frame: At the time of delivery
Rate of Shoulder Dystocia
Time frame: Within 12 hours of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 8559516Alexander GR, Himes JH, Kaufman RB, Mor J, Kogan M. A United States national reference for fetal growth. Obstet Gynecol. 1996 Feb;87(2):163-8. doi: 10.1016/0029-7844(95)00386-X.
- BackgroundCenters for Disease Control and Prevention (CDC). (2022). National Diabetes Statistics Report
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Mastrogiannis, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPT-based counseling and Nutritional Counseling in people with Gestational Diabetes, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth weight at time of Delivery (time frame: Within 12 hours of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06582719, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.