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

In arruolamento
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La sperimentazione clinica NCT07449039 (POSTPOD) è uno studio interventistico per Diabete mellito gestazionale in gravidanza, attualmente in arruolamento. Avviato il 28 settembre 2025, prevede di arruolare 50 partecipanti. Sotto la guida di l'Università della California, Los Angeles, dovrebbe concludersi entro il 1 giugno 2030. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 4 marzo 2026.
Sommario breve
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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Titolo ufficiale

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

Patologie
Diabete mellito gestazionale in gravidanza
Altri ID dello studio
  • POSTPOD
  • 25-0020
Numero NCT
Data di inizio (effettiva)
2025-09-28
Ultimo aggiornamento pubblicato
2026-03-04
Data di completamento (stimata)
2030-06
Arruolamento (previsto)
50
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Scopo principale
Altro
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
AltroContinuous 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.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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 alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Femmina
  • 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 logoUniversità della California, Los Angeles341 studi clinici attivi da esplorare
Parte responsabile dello studio
Christina S. Han, Investigatore principale, Division Director, Maternal-Fetal Medicine, University of California, Los Angeles
Contatti principali dello studio
Contatto: Rujuta Sathe, 310-794-8893, [email protected]
Contatto: Dana Levin-Lopez, MPH, 310-794-8893, [email protected]
1 Centri dello studio in 1 paesi

California

University of California, Los Angeles, Los Angeles, California, 90095, United States
Dana Levin-Lopez, MPH, Contatto, 310-794-8893, [email protected]
In arruolamento