Trial Radar AI | ||
|---|---|---|
De klinische studie NCT06184373 (ENGAGED) voor Zwangerschapsdiabetes, Hyperglykemie 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
Terug naar zoekresultaten
Ohio State UniversityEarly Investigation of Glucose Monitoring After Gestational Diabetes Pilot (ENGAGED) 20 Postpartum
Informatie over klinische studies is voornamelijk in het Engels beschikbaar. Trial Radar AI kan echter helpen! Klik op 'Leg studie uit' om de informatie over de studie te bekijken en te bespreken in de taal van uw keuze.
De klinische studie NCT06184373 (ENGAGED) is een observationeel studie bij Zwangerschapsdiabetes, Hyperglykemie met de status rekruterend. Het doel is om 20 deelnemers te includeren vanaf 6 juni 2025. De studie wordt geleid door Ohio State University en de voltooiing is gepland op 30 mei 2027. Laatste update op ClinicalTrials.gov: 22 januari 2026.
Beknopte samenvatting
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...Toon meer
Uitgebreide beschrijving
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...Toon meer
Officiële 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
Aandoeningen
ZwangerschapsdiabetesHyperglykemieAndere studie-ID's
- ENGAGED
- 2023H0066
NCT-ID
Startdatum (Werkelijk)
2025-06-06
Laatste update geplaatst
2026-01-22
Verwachte einddatum
2027-05-30
Inschrijving (Geschat)
20
Studietype
Observationeel
Status
Rekruterend
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
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. | Continue glucosemonitor CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum. Orale glucosetolerantietest 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. Hemoglobine 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 |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Vrouw
Accepteert gezonde vrijwilligers
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
Ohio State University456 actieve klinische studies om te verkennenDexCom, Inc.Verantwoordelijke instantie
Rachel D'Amico, Hoofdonderzoeker, Assistant Professor, Ohio State University
Centraal Contactpersoon
Contact: Rachel Gordon, MD, MPH, 614-293-7980, [email protected]
Contact: Seuli Brill, MD, 614-293-7980, [email protected]
1 Studielocaties in 1 landen
Ohio
Ohio State University Medical Center, Columbus, Ohio, 43210, United States
Rece Foss, Contact, 614-293-8000, [email protected]
Rekruterend