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Postpartum Continuous Glucose Monitoring for Type 2 Diabetes Mellitus Risk Evaluation in Patients With Gestational Diabetes Mellitus: POSTPOD Trial 50 Pós-parto

Em recrutamento
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07449039 (POSTPOD) é um estudo intervencionista para Diabetes mellitus gestacional na gravidez. Seu status atual é: em recrutamento. O estudo começou em 28 de setembro de 2025 e pretende incluir 50 participantes. Coordenado por a Universidade da Califórnia, Los Angeles e deve ser concluído em 1 de junho de 2030. Essas informações foram atualizadas no ClinicalTrials.gov em 4 de março de 2026.
Resumo
This is a pilot study designed to evaluate the effectiveness of continuous glucose monitoring (CGM) within hours of delivery to predict long-term risk of Type 2 Diabetes Mellitus in patients diagnosed with gestational diabetes.

Participants will be provided a CGM within 2 hours after delivery and wear the device for 24 hours. Participants will be instructed to peel off the device after 24 hours. Participants will al...

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Título oficial

Postpartum Continuous Glucose Monitoring for Type 2 Diabetes Mellitus Risk Evaluation in Patients With Gestational Diabetes Mellitus: POSTPOD Trial

Condições médicas
Diabetes mellitus gestacional na gravidez
Outros IDs do estudo
  • POSTPOD
  • 25-0020
Número NCT
NCT07449039
Data de início (real)
2025-09-28
Última atualização postada
2026-03-04
Data de conclusão (estimada)
2030-06
Inscrição (estimada)
50
Tipo de estudo
Intervencionista
FASE
N/A
Status
Em recrutamento
Propósito principal
Outro
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
OutroContinuous Glucose Monitor
Administration of a Continuous Glucose Monitor within 2 hours after delivery for 24-hour collection of glycemic data.
Continuous Glucose Monistor
Continuous glucose monitoring sensor that provides 24/7 detailed glycemic information. Participants will wear for 24 hours and then be instructed to peel off.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Clinical Efficacy Associated with CGM use immediately postpartum as compared to the 2 hr Glucose tolerance test
Regression analysis to assess strength and direction of the relationship between postpartum CGM data and 2 hr GTT
24 hours postpartum and 1-3 months postpartum
Clinical Efficacy Associated with CGM use immediately postpartum as compared to the HbA1c test postpartum
Regression analysis to assess strength and direction of the relationship between postpartum CGM data and HbA1c
24 hours postpartum and 1-3 months postpartum
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Patient satisfaction with CGM use immediately postpartum to evaluate long term risk
Patient satisfaction will be measured via survey response on following statements using 5 point likert scale * Applying the CGM was painless. * Applying the CGM was easy. * Wearing the CGM for 24 hours postpartum was painless. * Wearing the CGM for 24 hours postpartum was easy. * Wearing the CGM did not interfere with my activities of daily living. * Wearing the CGM did not cause any side effects. * Removing the CGM was painless. * Removing the CGM was easy. * If given a choice between the 1-3 month postpartum OGTT and wearing the CGM for 24 hours immediately postpartum, I would choose wearing the CGM.
1-3 months postpartum after glucose tolerance test, 12-24 months postpartum after A1C blood test
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Feminino
  • Prenatal care at UCLA Health
  • Planning to deliver at UCLA Ronald Reagan or UCLA Santa Monica
  • Confirmed gestational diabetes diagnosis based on 2-step approach
  • Maternal age >= 18 years

  • Pre-gestational diabetes (T1DM or T2DM)
  • Multifetal gestation
  • Intra-amniotic infection by clinical criteria
  • Postpartum hemorrhage
  • Maternal ICU admission
  • Known allergy to medical-grade adhesive
  • Presence of skin lesions at anticipated CGM application site
  • Scheduled postpartum non-sonographic imaging study (radiograph, magnetic resonance imaging (MRI), or computed tomography (CT) scan) during trial
  • Metformin use
  • Steroid use
  • Terbutaline use within 4 hours of delivery
  • Cystic fibrosis
  • MODY (mature onset of diabetes in the young)
University of California, Los Angeles logoUniversidade da Califórnia, Los Angeles341 estudos clínicos ativos para explorar
Responsável pelo estudo
Christina S. Han, Investigador principal, Division Director, Maternal-Fetal Medicine, University of California, Los Angeles
Contato central do estudo
Contato: Rujuta Sathe, 310-794-8893, [email protected]
Contato: Dana Levin-Lopez, MPH, 310-794-8893, [email protected]
1 Locais do estudo em 1 países

California

University of California, Los Angeles, Los Angeles, California, 90095, United States
Dana Levin-Lopez, MPH, Contato, 310-794-8893, [email protected]
Em recrutamento