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De klinische studie NCT07449039 (POSTPOD) voor Zwangerschapsdiabetes mellitus tijdens de zwangerschap is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Postpartum Continuous Glucose Monitoring for Type 2 Diabetes Mellitus Risk Evaluation in Patients With Gestational Diabetes Mellitus: POSTPOD Trial 50 Postpartum
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De klinische studie NCT07449039 (POSTPOD) is een interventioneel studie bij Zwangerschapsdiabetes mellitus tijdens de zwangerschap met de status rekruterend. Het doel is om 50 deelnemers te includeren vanaf 28 september 2025. De studie wordt geleid door de Universiteit van Californië, Los Angeles en de voltooiing is gepland op 1 juni 2030. Laatste update op ClinicalTrials.gov: 4 maart 2026.
Beknopte samenvatting
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...
Toon meerOfficiële titel
Postpartum Continuous Glucose Monitoring for Type 2 Diabetes Mellitus Risk Evaluation in Patients With Gestational Diabetes Mellitus: POSTPOD Trial
Aandoeningen
Zwangerschapsdiabetes mellitus tijdens de zwangerschapAndere studie-ID's
- POSTPOD
- 25-0020
NCT-ID
Startdatum (Werkelijk)
2025-09-28
Laatste update geplaatst
2026-03-04
Verwachte einddatum
2030-06
Inschrijving (Geschat)
50
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Primaire doel
Overige
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
OverigeContinuous 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. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Vrouw
- 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)
Verantwoordelijke instantie
Christina S. Han, Hoofdonderzoeker, Division Director, Maternal-Fetal Medicine, University of California, Los Angeles
Centraal Contactpersoon
Contact: Rujuta Sathe, 310-794-8893, [email protected]
Contact: Dana Levin-Lopez, MPH, 310-794-8893, [email protected]
1 Studielocaties in 1 landen
California
University of California, Los Angeles, Los Angeles, California, 90095, United States
Dana Levin-Lopez, MPH, Contact, 310-794-8893, [email protected]
Rekruterend