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Artificial Intelligence and Gestacional Diabetes

J

JOSE FERNANDO VILELA-MARTIN

Status

Invitation-only

Conditions

Gestational Diabetes
Macrosomia, Fetal

Treatments

Other: monitoring model for women with gestacional diabetes using pharmacological therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07345143
78204024.6.0000.5415.

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Device group: Case group (AI model use)
Experimental group
Description:
Case group - Device group. AI model to monitor glucose control and send education to treat women with gestacional diabetes in insulin treatment.
Treatment:
Other: monitoring model for women with gestacional diabetes using pharmacological therapy
Control group (no use of AI model)
No Intervention group
Description:
No device group: Control group - women with gestacional diabetes in insulin treatment under conventional treatment, without the AI model use.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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