Artificial Intelligence and Gestacional Diabetes

January 6, 2026 updated by: JOSE FERNANDO VILELA-MARTIN

Artificial Intelligence in Education and Monitoring Women With Gestational Diabetes

Artificial intelligence (AI) technology can assist medical teams in remote monitoring and continuing education of women with gestational diabetes (GDM), potentially improving adherence to interventions and impacting outcomes. An AI remote monitoring model called "monitoring model for women with GDM using pharmacological therapy," created by the ChamouDr technical team, will be analyzed focusing on disease education, glycemic control monitoring, and therapeutic interventions. Women diagnosed with GDM are invited to participate in the study and sign a free and informed consent form. The AI tool is installed on the pregnant woman's cell phone, who receives instructions to collect capillary blood glucose 6 times a day according to the protocol, at home, and report the results via WhatsApp to the study tool. Algorithm generated by the AI model based on self monitoring of blood glucose (SMBG) informs about diabetes control in the last week. The dashboard is accessible via a web browser, and signals: in green and red for patients with satisfactory and unsatisfactory control, respectively. Thus, the AI model optimizes the team's time in analyzing and treating patients appropriately in a simple, cost-effective, and accessible way.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

AI technology can assist medical teams in remote monitoring and continuing education of women with GDM. Objective: To analyze the results of using an AI model in remote monitoring and continuing education of women with GDM and pharmacological treatment, correlating them with clinical outcomes for the mother-fetus binomial. Methods: prospective, longitudinal, interventional clinical study approved by the local ethics committee. Patients signed a consent form to participate. An AI remote monitoring model called "monitoring model for women with GDM using pharmacological therapy," created by the ChamouDr technical team, will be analyzed focusing on disease education, glycemic control monitoring, and therapeutic interventions. The modell uses WhatsApp®, through a structured chatbot and AI resources, to communicate with the participant. Comparative analyses will be conducted between two groups of 100 pregnant women with GDM on insulin therapy, followed in the high-risk prenatal clinic of the Obstetrics Department of a tertiary hospital: case group using the AI model versus control group, composed of patients previously monitored under conventional in-person supervision, without the use of this technology. Algorithm generated by the AI model based on SMBG informs about diabetes control in the last week. The dashboard is accessible via a web browser, and signals: in green and red for patients with satisfactory and unsatisfactory control, respectively. Thus, the AI model optimizes the team's time in analyzing and treating patients appropriately in a simple, cost-effective, and accessible way.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gestacional diabetes women with gestational age of up to 28 weeks and 6 days
  • Gestacional diabetes women who sign the free and informed consent form

Exclusion Criteria:

  • Gestational age greater than 28 completed weeks at the first consultation
  • Participants with overt DM (fasting glucose > 126 mg/dl or postprandial > 200 mg/dl)
  • Unknown outcome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Device group: Case group (AI model use)
Case group - Device group. AI model to monitor glucose control and send education to treat women with gestacional diabetes in insulin treatment.
Other: monitoring model for women with gestacional diabetes using pharmacological therapy
Artificial Intelligence modell through WhatsApp® to remote monitoring gestacional diabetes in insulin treatment, focusing on disease education, glycemic control monitoring, and therapeutic interventions.
Other Names:
  • artificial intelligence for women with gestacional diabetes
No Intervention: Control group (no use of AI model)
No device group: Control group - women with gestacional diabetes in insulin treatment under conventional treatment, without the AI model use.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
fetal death
Time Frame: From the moment of randomization to delivery (until 40 weeks of pregnancy)
Fetal death resulting from metabolic changes caused by gestational diabetes
From the moment of randomization to delivery (until 40 weeks of pregnancy)
Fetal birth weight
Time Frame: From the moment of randomization to delivery (until 40 weeks of pregnancy)
Fetal weight at birth assessed using a precision scale.
From the moment of randomization to delivery (until 40 weeks of pregnancy)
neonatal hypoglycemia
Time Frame: From the moment of randomization to delivery (until 40 weeks of pregnancy), and Assessment of neonatal blood glucose levels from birth up to 48 hours post-birth.

Neonatal hypoglycemia is the abnormal reduction of glucose in the newborn's blood to levels considered insufficient to meet the metabolic needs of the brain and other tissues. Plasma glucose parameters:

< 40 mg/dL in the first 4 hours of life, < 45 mg/dL between 4 and 24 hours of life, After 24 hours, values < 50-60 mg/dL
From the moment of randomization to delivery (until 40 weeks of pregnancy), and Assessment of neonatal blood glucose levels from birth up to 48 hours post-birth.
glycemic control
Time Frame: From the moment of randomization to delivery (until 40 weeks of pregnancy)
Glycemic control will be evaluated according to capillary glucose measurements that are taken 6 times a day: fasting, before and 1 hour after meals, following the target ranges of 70 to 95 mg/dL fasting; 70 ton 100 mg/dL pre-prandial; and 100 to 140 mg/dL post-prandial.
From the moment of randomization to delivery (until 40 weeks of pregnancy)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
admission of the newborn to the intensive care unit
Time Frame: From the moment of randomization to delivery (until 40 weeks of pregnancy), and from birth to 48 hours postpartum
The need for the newborn to be admitted to an intensive care unit due to metabolic disorders associated with poor maternal glycemic control.
From the moment of randomization to delivery (until 40 weeks of pregnancy), and from birth to 48 hours postpartum
mother weight gain
Time Frame: From the moment of randomization to delivery (until 40 weeks of pregnancy).
Maternal weight gain assessed during the gestational follow-up period up to delivery.
From the moment of randomization to delivery (until 40 weeks of pregnancy).
gestational age at delivery
Time Frame: From the moment of randomization to delivery (until 40 weeks of pregnancy).
Gestational age at the time of natural childbirth or cesarean section in weeks
From the moment of randomization to delivery (until 40 weeks of pregnancy).
route of delivery
Time Frame: From the moment of randomization to delivery (until 40 weeks of pregnancy).
Description of whether it was a natural birth or a cesarean section.
From the moment of randomization to delivery (until 40 weeks of pregnancy).
Blood pressure
Time Frame: From the moment of randomization to delivery (until 40 weeks of pregnancy).
Evaluate if hypertension is present and assess blood pressure levels during pregnancy and up to delivery.
From the moment of randomization to delivery (until 40 weeks of pregnancy).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JOSE FERNANDO VILELA-MARTIN

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: José F Vilela-Martin, MD, PhD, Hospital de Base
  • Principal Investigator: Vanessa V Goulart, MD, MSc, Hospital de Base, Sao Jose do Rio Preto, Sao Paulo, Brazil
  • Study Chair: Ligia C Junqueira, MD, Hospital de Base, Sao Jose do Rio Preto, Sao Paulo, Brazil
  • Study Chair: Amanda T Lotierzo, MD, Hospital de Base, Sao Jose do Rio Preto, Sao Paulo, Brazil
  • Study Chair: Carolina C Amorim, MD, Hospital de Base, Sao Jose do Rio Preto, Sao Paulo, Brazil
  • Study Chair: Maria Amalia BC Cançado, MD, Hospital de Base, Sao Jose do Rio Preto, Sao Paulo, Brazil
  • Study Chair: Leticia A Mantoani, student, Hospital de Base, Sao Jose do Rio Preto, Sao Paulo, Brazil
  • Study Chair: Rodrigo F Zancaner, Chamoudr company
  • Study Chair: Rafael Beolchi, Chamoudr company
  • Study Chair: Lucas F Queiroz, Chamoudr company
  • Study Chair: Luciana N Cosenso-Martin, MD, PhD, Hospital de Base, Sao Jose do Rio Preto, Sao Paulo, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 78204024.6.0000.5415.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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