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

Enrolling by invitation

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

100

Phase

  • 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

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
Intervention / Treatment
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

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

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

JOSE FERNANDO VILELA-MARTIN

Investigators

  • 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)

June 1, 2024

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 20, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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