Artificial Intelligence and Gestacional Diabetes

Sponsor
JOSE FERNANDO VILELA-MARTIN
Study ID
NCT07345143
Status
Enrolling By Invitation

Conditions

  • Gestational Diabetes
  • Macrosomia, Fetal

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • monitoring model for women with gestacional diabetes using pharmacological therapy — OTHER
    Artificial Intelligence modell through WhatsApp® to remote monitoring gestacional diabetes in insulin treatment, focusing on disease education, glycemic control monitoring, and therapeutic interventions.

Study Details

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.

Key Dates

First listed
Jan 15, 2026
Start date
Jun 1, 2024
Status verified
Jan 2025
Primary completion
Dec 20, 2026
Completion
Dec 20, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

fetal death [ Time Frame: From the moment of randomization to delivery (until 40 weeks of pregnancy) ]

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