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Adhesive Materials for Continuous Glucose Monitoring Systems Novateur

Retiré
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L'essai clinique NCT03340467 est une étude interventionnel pour Diabète sucré. Son statut actuel est : retiré. L'étude a débuté le 1 août 2018 et vise à recruter N/A participants. Dirigée par Metronom Health, l'étude devrait être terminée d'ici le 30 septembre 2018. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 19 août 2019.
Résumé succinct
Within the present study 4 different band-aid/adhesive combinations will be tested in patients with type 1 diabetes and type 2 diabetes with regard to adherence to the body and allergic potential. The study period is set to 21 days following adhesive material placement to cover the maximum expected wear-time of the novel CGM system (14 days) plus an additional seven days to ensure that adhesive material is tested for...Afficher plus
Titre officiel

Evaluation of Different Types of Adhesive Materials for Continuous Glucose Monitoring Systems in Subjects With Type 1 and Type 2 Diabetes Mellitus

Pathologies
Diabète sucré
Autres identifiants de l'étude
  • ADHERE_01
Numéro NCT
NCT03340467
Date de début (réel)
2018-08-01
Dernière mise à jour publiée
2019-08-19
Date de fin (estimée)
2018-09-30
Type d'étude
Interventionnel
PHASE
N/A
Statut
Retiré
Objectif principal
Autre
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalCGM patch
Patient receives four models of CGM patches. Adhesion sites are randomly allocated (1 on each upper arm, 2 on the abdomen).
CGM patch
Patient receives four CGM patches.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Survival rate
14 days survival rate of different models of CGM patches to fixate a CGM sensor system.
21 days
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Survival time
Survival time (time to peel-off) of different models of CGM patches to fixate a CGM sensor system
21 days
Attachment site reactions
Erythema, edema and blister formation according to ICDRG scoring system
21 days
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • Informed consent obtained after being advised of the nature of the study
  • Male or female aged ≥18 years
  • Type 1 diabetes for at least 6 months according to the WHO definition or Type 2 diabetes for at least 6 months according to the WHO definition
  • Body Mass Index (BMI) <45 kg/m²
  • Willing and able to wear 4 different band-aid/adhesive materials for the duration of the study and undergo all study procedures
  • HbA1c ≤86 mmol/mol

  • Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
  • Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
  • Any mental condition rendering the subject incapable of giving his consent
  • Subject is using any medication that significantly impacts immune response (oral steroids)
  • Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
  • Subject is actively enrolled in another clinical trial
  • Known severe hypersensitivity to adhesive or skin lesions that hinder band-aid application
  • Inability of the subject to comply with all study procedures
  • Inability of the subject to understand the subject information
  • Has children two years of age or younger
  • Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken ("protected majors" as per French law).
Metronom Health logoMetronom Health
Medical University of Graz logoUniversité de médecine de Graz118 essais cliniques actifs à explorer
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