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L'essai clinique NCT04948112 (STEADYSUGAR) pour Diabète sucré gestationnel pendant la grossesse est terminé. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Effectiveness of CGMS Vs. Self-monitoring Blood Glucose (SMBG) in Woman with Gestational Diabetes (STEADYSUGAR) 128
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT04948112 (STEADYSUGAR) a été une étude interventionnel pour Diabète sucré gestationnel pendant la grossesse. Son statut actuel est : terminé. L'étude a commencé le 1 octobre 2021, avec un objectif de recruter 128 participants. Dirigée par Woman's, l'étude s'est terminée le 30 juin 2024. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 18 octobre 2024.
Résumé succinct
The detection of and control of gestational diabetes carries benefits for both mother and baby related to immediate pregnancy outcomes. The glycemic disorders in diabetes are not solely limited to fasting and postprandial hyperglycemia, but can be extended to the glycemic variability that includes both upward (postprandial glucose increments) and downward (interprandial glucose decrements) changes. Glycemic variabili...Afficher plus
Description détaillée
Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance with onset during pregnancy. It is associated with increased feto-maternal morbidity as well as with long-term complications in the mother and offspring . GDM is associated with significant complications during pregnancy, including an increased need for Cesarean sections; higher risks of ketonemia, preeclampsia, and urinary tract infe...Afficher plus
Titre officiel
Effectiveness of Real-time Continuous Glucose Monitoring (CGMS) to Improve Glycemic Control in Patients with Early Gestational Diabetes Mellitus: a Randomized Controlled Trial Using CGMS Vs. Self-monitoring Blood Glucose (SMBG)
Pathologies
Diabète sucré gestationnel pendant la grossesseAutres identifiants de l'étude
- STEADYSUGAR
- RP-21-012
Numéro NCT
Date de début (réel)
2021-10-01
Dernière mise à jour publiée
2024-10-18
Date de fin (estimée)
2024-06-30
Inscription (estimée)
128
Type d'étude
Interventionnel
PHASE
N/A
Statut
Terminé
Mots clés
continuous glucose monitoring
Objectif principal
Diagnostic
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalReal-time (rt) CGMS with SMBG Real time continuous glucose monitoring plus self-monitored blood glucose | real time continuous glucose monitor CGM sensor will read blood glucose every 10 minutes |
Comparateur actifSMBG with blinded CGM Self monitored blood glucose with blinded continuous glucose monitoring | blinded continuous glucose monitor CGM that records blood glucose but not visible to patient |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Average percent time in glucose range | average time in hours and minutes spent in target glucose range | up to 32 weeks |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
time spent in hyperglycemia (time above range) | average time in hours and minutes spent with elevated blood glucose | up to 32 weeks |
time spent in hypoglycemia (time below range) | average time in hours and minutes spent with low blood glucose | up to 32 weeks |
percent weight gain during pregnancy | change in bodyweight during pregnancy | through study completion, an average of 38 weeks |
HbA1c | change (lowering or increasing) HbA1C | through study completion, an average of 38 weeks |
Large-for -gestational age newborns | the proportion of LGA newborns (birth weight \>90th percentile) | at time of delivery |
Neonatal hypoglycemia | blood glucose level below 2.2 mmol/L (40 mg/dL) | at time of delivery |
Critères d'éligibilité
Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Femme
• 8-26 weeks gestation
- singleton pregnancy,
- a positive oral glucose tolerance test
- written informed consent.
• prior diagnosis of diabetes mellitus,
- presence of infection,
- Presence of significant systemic disease or other severe metabolic, endocrine, medical co-morbidities
- history of bariatric surgery or other surgeries that induce malabsorption
- long-term use (>2 weeks) of systemic steroids prior to enrolment
- multiple pregnancy
- patients already using glucose lowering medications (metformin or insulin) before study entry
- fetal growth restriction due to placental dysfunction at study entry
- History of major depressive or other severe psychiatric disorders or inpatient psychiatric treatment up to 1year before enrolment
- Inability or refusal to comply with protocol
- Currently participating or having participated in an experimental study in previous three months
Woman'sDexCom, Inc.Aucune donnée de contact disponible
1 Centres de l'étude dans 1 pays
Louisiana
Karen Elkind-Hirsch, Baton Rouge, Louisiana, 70817, United States