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L'essai clinique NCT07345143 pour Diabète gestationnel, Macrosomie fœtale est recrutement sur invitation. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Artificial Intelligence and Gestacional Diabetes 100 À domicile Grossesse À distance
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07345143 est une étude interventionnel pour Diabète gestationnel, Macrosomie fœtale. Son statut actuel est : recrutement sur invitation. L'étude a débuté le 1 juin 2024 et vise à recruter 100 participants. Dirigée par JOSE FERNANDO VILELA-MARTIN, l'étude devrait être terminée d'ici le 20 décembre 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 15 janvier 2026.
Résumé succinct
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, ...Afficher plus
Description détaillée
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 ...Afficher plus
Titre officiel
Artificial Intelligence in Education and Monitoring Women With Gestational Diabetes
Pathologies
Diabète gestationnelMacrosomie fœtalePublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- 78204024.6.0000.5415.
Numéro NCT
Date de début (réel)
2024-06-01
Dernière mise à jour publiée
2026-01-15
Date de fin (estimée)
2027-12-20
Inscription (estimée)
100
Type d'étude
Interventionnel
PHASE
N/A
Statut
Recrutement sur invitation
Mots clés
artificial intelligence
gestacional diabetes
machine learning
glucose monitoria
glucose sensor
gestacional diabetes
machine learning
glucose monitoria
glucose sensor
Objectif principal
Traitement
Méthode d'allocation
Non randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalDevice 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. | 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. |
Aucune interventionControl 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. | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
fetal death | 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 | Fetal weight at birth assessed using a precision scale. | 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 | 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. | From the moment of randomization to delivery (until 40 weeks of pregnancy) |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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. | 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. | 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 | 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. | 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. | From the moment of randomization to delivery (until 40 weeks of pregnancy). |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Femme
- 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
- 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.
JOSE FERNANDO VILELA-MARTINPartie responsable de l'étude
JOSE FERNANDO VILELA-MARTIN, Promoteur-Investigateur, MD, PHD, Hospital de Base
Aucune donnée de contact disponible
1 Centres de l'étude dans 1 pays
São Paulo
Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto, São Paulo, 15090-000, Brazil