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

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07449039 (POSTPOD) ist eine interventionsstudie zur Untersuchung von Schwangerschaftsdiabetes mellitus in der Schwangerschaft und hat den Status offene rekrutierung. Die Studie startete am 28. September 2025 und soll 50 Teilnehmer aufnehmen. Durchgeführt von Universität von Kalifornien, Los Angeles ist der Abschluss für 1. Juni 2030 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 4. März 2026 aktualisiert.
Kurzbeschreibung
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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Offizieller Titel

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

Erkrankungen
Schwangerschaftsdiabetes mellitus in der Schwangerschaft
Weitere Studien-IDs
  • POSTPOD
  • 25-0020
NCT-Nummer
NCT07449039
Studienbeginn (tatsächlich)
2025-09-28
Zuletzt aktualisiert
2026-03-04
Studienende (vorauss.)
2030-06
Geplante Rekrutierung
50
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Andere
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
AndereContinuous 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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich
  • 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 logoUniversität von Kalifornien, Los Angeles341 aktive klinische Studien zum Erkunden
Verantwortliche Partei
Christina S. Han, Hauptprüfer, Division Director, Maternal-Fetal Medicine, University of California, Los Angeles
Zentrale Studienkontakte
Kontakt: Rujuta Sathe, 310-794-8893, [email protected]
Kontakt: Dana Levin-Lopez, MPH, 310-794-8893, [email protected]
1 Studienstandorte in 1 Ländern

California

University of California, Los Angeles, Los Angeles, California, 90095, United States
Dana Levin-Lopez, MPH, Kontakt, 310-794-8893, [email protected]
Offene Rekrutierung