Connexion
M'inscrire

Votre recherche

Filtres

Project précédent
Projet suivant
Nous verifions auprès de chaque centre si des nouvelles informations sont disponibles

ADC-US-RES-19185

Evaluation of flash continuous glucose monitoring to reduce hyperglycemia in people with t2 diabetes
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT04843527
Recrutement fermé
Dernière modification : 2025/01/29
Type de recherche

Interventionnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Subject must be at least 18 years of age.
* Subject has been diagnosed with type 2 diabetes.
* HbA1c greater than or equal to 7.5% and less than or equal to 12%
* Subject is on at least 1 diabetes medication in the classes of metformin, SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors.
* Subject owns a compatible smartphone
* Subject agrees to a 3-month period of no diabetes medication changes.
* Subject is willing to make diet and lifestyle changes in response to education and glucose data

Exclusion Criteria:

* Subject is currently on insulin therapy or sulfonylurea-based medications.
* Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
* Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only).
* Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
FreeStyle Libre Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes. Donnée non disponible
  • Inconnu
  • FreeStyle Libre plus food logging Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes. Donnée non disponible
  • Inconnu
  • FreeStyle Libre
    État du recrutement
    unknown
    FreeStyle Libre plus food logging
    État du recrutement
    unknown
    Données à jour depuis : 29 janvier 2025

    Description de l'étude

    Résumé de l'étude

    A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.

    Source : Importé depuis le centre

    Approximately 350 subjects will be enrolled to obtain at least 84 randomized subjects,approximately 42 subjects per arm. Subjects will be randomized to use either the FreeStyle Libre Flash Glucose Monitoring System or FreeStyle Libre Flash Glucose Monitoring System with a food logging smartphone application to manage their diabetes.

    The subsequent impact on reducing the amount of time spent above 180 mg/dL will be assessed.

    Source : Importé depuis le centre

    Sites

    Centres participants

      4 centres
    • BOSTON MEDICAL CENTER

      Boston

      MASSACHUSETTS, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ
    • CHILDREN'S HOSPITAL OF PITTSBURGH (OF UMPC)

      Pittsburgh

      PENNSYLVANIA, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ
    • HEALTHPARTNERS INSTITUTE DBA INTERNATIONAL DIABETES CENTER

      Minneapolis

      MINNESOTA, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ
    • HENRY FORD HEALTH SYSTEM, DEPT OF OPHTHALMOLOGY AND EYE CARE SERVICES

      Detroit

      MICHIGAN, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ

    Dernière modification : 29 janvier 2025
    Données à jour depuis : 31 jan.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT04843527