An interventional study of monitoring model for women with gestacional diabetes using pharmacological therapy in Gestational Diabetes and Macrosomia, Fetal, sponsored by JOSE FERNANDO VILELA-MARTIN. Enrolling by invitation at 1 site in Brazil. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by JOSE FERNANDO VILELA-MARTIN · Not applicable, Interventional, and Treatment
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.
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.
32 studies on the registry are indexed under Fetal Macrosomia; 6 are open to participants now.
This study's planned enrollment of 100 is below the median of 222 across 13 interventional studies indexed under Fetal Macrosomia.
Browse Fetal Macrosomia studies →This is the only study on the registry with JOSE FERNANDO VILELA-MARTIN as lead sponsor.
Compared within Fetal Macrosomia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes, Gestational. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No device group: Control group - women with gestacional diabetes in insulin treatment under conventional treatment, without the AI model use.
Artificial Intelligence modell through WhatsApp® to remote monitoring gestacional diabetes in insulin treatment, focusing on disease education, glycemic control monitoring, and therapeutic interventions.
Also known as: artificial intelligence for women with gestacional diabetes
fetal death
Fetal death resulting from metabolic changes caused by gestational diabetes
Time frame: From the moment of randomization to delivery (until 40 weeks of pregnancy)
Fetal birth weight
Fetal weight at birth assessed using a precision scale.
Time frame: From the moment of randomization to delivery (until 40 weeks of pregnancy)
neonatal hypoglycemia
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
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.
glycemic control
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.
Time frame: From the moment of randomization to delivery (until 40 weeks of pregnancy)
admission of the newborn to the intensive care unit
The need for the newborn to be admitted to an intensive care unit due to metabolic disorders associated with poor maternal glycemic control.
Time frame: From the moment of randomization to delivery (until 40 weeks of pregnancy), and from birth to 48 hours postpartum
mother weight gain
Maternal weight gain assessed during the gestational follow-up period up to delivery.
Time frame: From the moment of randomization to delivery (until 40 weeks of pregnancy).
gestational age at delivery
Gestational age at the time of natural childbirth or cesarean section in weeks
Time frame: From the moment of randomization to delivery (until 40 weeks of pregnancy).
route of delivery
Description of whether it was a natural birth or a cesarean section.
Time frame: From the moment of randomization to delivery (until 40 weeks of pregnancy).
Blood pressure
Evaluate if hypertension is present and assess blood pressure levels during pregnancy and up to delivery.
Time frame: From the moment of randomization to delivery (until 40 weeks of pregnancy).
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.