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Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot (ENGAGED) 20 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 NCT06184373 (ENGAGED) ist eine beobachtungsstudie zur Untersuchung von Schwangerschaftsdiabetes, Hyperglykämie und hat den Status offene rekrutierung. Die Studie startete am 6. Juni 2025 und soll 20 Teilnehmer aufnehmen. Durchgeführt von Ohio State University ist der Abschluss für 30. Mai 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 22. Januar 2026 aktualisiert.
Kurzbeschreibung
One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of li...Mehr anzeigen
Ausführliche Beschreibung
Gestational diabetes (GDM) is associated with a significantly increased risk of type 2 diabetes, with 1/3 of individuals with GDM developing glucose intolerance in the first 3 years postpartum. The American Diabetes Association recommends a follow up oral glucose tolerance test (OGTT) 4-12 weeks after delivery for all patients with GDM, but rates of follow up screening are as low as 19%. OGTT presents many challenges...Mehr anzeigen
Offizieller Titel

Early Investigation of Glucose Monitoring After Gestational Diabetes (ENGAGED): Utility and Acceptability of Continuous Glucose Monitoring in the Early Postpartum Period After Gestational Diabetes Mellitus

Erkrankungen
SchwangerschaftsdiabetesHyperglykämie
Weitere Studien-IDs
  • ENGAGED
  • 2023H0066
NCT-Nummer
NCT06184373
Studienbeginn (tatsächlich)
2025-06-06
Zuletzt aktualisiert
2026-01-22
Studienende (vorauss.)
2027-05-30
Geplante Rekrutierung
20
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Participants
Participants will be recruited at 6-8 weeks postpartum; at that appointment, CGMs will be placed. After wearing the CGM, participants will fill out surveys regarding their experience. At 10-12 weeks postpartum, they will complete the standard of care OGTT as well as complete an interview regarding their experience. At 12 months postpartum, they will complete a blood test to check their hemoglobin A1c.
Kontinuierlicher Glukosemonitor
CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum.
Oraler Glukosetoleranztest
At 10-12 weeks postpartum, participants will complete an oral glucose tolerance test, which involves drinking a glucose substance and having glucose levels measured a maximum of 3 times.
Hämoglobin A1c
At 11-14 months postpartum, participants will be asked to have their blood drawn to check their hemoglobin A1c to look for signs of developed insulin resistance
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Acceptability of CGM
As determined by survey
15 weeks from enrollment
Comparative experience of OGTT and CGM
As determined by survey
15 weeks from enrollment
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Prevalence and characteristics of dysglycemia in GDM postpartum
As determined by survey
15 weeks from enrollment
Lifestyle changes survey
Breastfeeding practices, changes in diet and physical activity
15 weeks from enrollment
Medical care
Number of doctor's visits (both for participant and their infant), prescribed medications
15 weeks from enrollment
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich
Akzeptiert gesunde Freiwillige
Ja
  • Women with a viable singleton intrauterine pregnancy
  • Able to understand the study, and having understood, provide written informed consent in English
  • Recent pregnancy affected by gestational diabetes

  • Pregestational Diabetes (Type I or Type II)
  • Continued use of diabetes medications (including metformin and insulin) immediately after delivery
  • Preterm delivery (< 37 weeks gestation)
  • Twin or higher order gestation
  • No access to a smartphone
  • Unable or unwilling to wear CGM or return for follow up at postpartum mother-infant dyad clinic
  • Participation in this trial in a prior pregnancy
  • History of skin allergy to adhesive products or CGM
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Verantwortliche Partei
Rachel D'Amico, Hauptprüfer, Assistant Professor, Ohio State University
Zentrale Studienkontakte
Kontakt: Rachel Gordon, MD, MPH, 614-293-7980, [email protected]
Kontakt: Seuli Brill, MD, 614-293-7980, [email protected]
1 Studienstandorte in 1 Ländern

Ohio

Ohio State University Medical Center, Columbus, Ohio, 43210, United States
Rece Foss, Kontakt, 614-293-8000, [email protected]
Offene Rekrutierung