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Integrating the Use of Calibration-Free Continuous Monitoring for Pregnancy Glucose Profiling: I-Profile Study 240 Randomisé Grossesse Observationnel

Terminé
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L'essai clinique NCT05123248 (I-Profile) a été une étude interventionnel pour Diabète gestationnel, Grossesse. Son statut actuel est : terminé. L'étude a commencé le 16 octobre 2018, avec un objectif de recruter 240 participants. Dirigée par KK Women's and Children's Hospital, l'étude s'est terminée le 31 août 2024. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 10 octobre 2024.
Résumé succinct

This study aims to test the following hypotheses in a longitudinal, observational study in pregnant women who will be randomized to received either a Blinded or Unblinded CGM sensor and followed-up 6-12 weeks after delivery:

  1. CF-CGM device is well tolerable and accurate for glucose level monitoring in women with a normal pregnancy.
  2. CF-CGM device is well tolerable and acceptable in women with GDM who are require...
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Description détaillée
GDM affects 5-10% of pregnant women in Europe, while the prevalence in Asian populations is significantly higher at approximately 15-20%. However, the GDM screening approaches, timing and targeted population still varies greatly in clinical practice all over the world, which makes the prevalence of GDM difficult to compare universally. Since the early days of the 21st century, the continuous glucose monitoring system...Afficher plus
Titre officiel

Integrating the Use of Calibration-Free Continuous Monitoring for Pregnancy Glucose Profiling: I-Profile Study

Pathologies
Diabète gestationnelGrossesse
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
  • I-Profile
  • 2018/2128
Numéro NCT
NCT05123248
Date de début (réel)
2018-10-16
Dernière mise à jour publiée
2024-10-10
Date de fin (estimée)
2024-08-31
Inscription (estimée)
240
Type d'étude
Interventionnel
PHASE
N/A
Statut
Terminé
Objectif principal
Diagnostic
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalBlinded Group
Participants in the blinded group will be wearing the sensor for 14 days without a reader. After 14 days, participants are required to scan the sensor themselves or with the assistance of a CRC to a designated blinded-reader.
Blinded Group
Participants in the blinded group will be wearing the sensor for 14 days without a reader. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. After 14 days, participants are required to scan the sensor themselves or with the assistance of a CRC to a designated blinded-reader.
ExpérimentalUnblinded Group
Participants in the non-blinded group are required to wear the sensor for 14 days with an open reader. The participant will be required to upload their glucose readings no longer than 8 hours by scanning the reader provided.
Unblinded group
Participants in the non-blinded group are required to wear the CGM sensor for 14 days with an open reader. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. The participant will be required to upload their glucose readings no longer than 8 hours by scanning the reader provided.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Gestational Diabetes Mellitus (GDM)
Clinical outcomes of Gestational Diabetes Mellitus (GDM) development determined by oral glucose tolerance test
24-31 weeks gestation
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
CGM summary metrics derived from extracted CGM glucose data
Glucose profiles extracted from the continous glucose monitoring (CGM) device
First trimester: 9-13 weeks, Second trimester: 18-23 weeks, 24-31 weeks, 32-33 weeks
Plasma glucose measures from OGTT
Fasting, one hour and 2 hour glucose values obtained from OGTT
24-31 weeks gestation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
21 Years
Sexes éligibles
Femme
Accepte les volontaires en bonne santé
Oui
  1. Participants who are Singapore citizens or Singapore Permanent Residents, and plan to be followed up throughout pregnancy and intend to deliver at KKH;
  2. Aged 21 and above;
  3. Singleton pregnancy

  1. Have serious skin conditions (e.g. eczema) that precludes wearing the sensor for 14 days;
  2. Patients who have any other chronic disease such as chronic kidney disease.
  3. Unable to read or speak English
KK Women's and Children's Hospital logoKK Women's and Children's Hospital
Aucune donnée de contact disponible
1 Centres de l'étude dans 1 pays
KK Women's and Children's Hospital, Singapore, 229899, Singapore