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Examining The Role of CGM in T2DM 35

Terminé
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 NCT01614262 a été une étude interventionnel pour DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder). Son statut actuel est : terminé. L'étude a commencé le 1 juin 2012, avec un objectif de recruter 35 participants. Dirigée par l'Université de Caroline du Nord à Chapel Hill, l'étude s'est terminée le 1 septembre 2014. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 19 avril 2017.
Résumé succinct
Continuous glucose monitoring (CGM) technology has advanced the treatment of people with diabetes, however to date this technology had been primarily limited to use in patients treated with insulin. CGM is a powerful tool that has the potential to enhance the care of patients treated with agents other than insulin; however this has not been tested. The purpose of this study is to determine whether improved glycemic c...Afficher plus
Description détaillée
The study will enroll and follow 90 participants for 187 days at two sites. Participants will be randomized (1:1 allocation ratio) to the CGM based intervention (Group 1) or the Self-Monitoring Blood Glucose (SMBG) based intervention (Group 2). Group 1 will receive care based upon the results of their CGM data while group 2 will receive care based upon traditional SMBG values. The clinical management algorithm will b...Afficher plus
Titre officiel

Examining the Role of Continuous Glucose Monitoring (CGM) in Non-Insulin Treated Type 2 Diabetes

Pathologies
DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)
Autres identifiants de l'étude
  • 12-0899
Numéro NCT
NCT01614262
Date de début (réel)
2012-06
Dernière mise à jour publiée
2017-04-19
Date de fin (estimée)
2014-09
Inscription (estimée)
35
Type d'étude
Interventionnel
PHASE
N/A
Statut
Terminé
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalContinuous Glucose Monitoring
The Continuous Glucose Monitoring (CGM) arm will receive care based upon results from there CGM data; treatment decisions are based on algorithm and CGM data
Continuous Glucose Monitoring with treatment algorithm
those subjects randomized to Continuous Glucose Monitoring results will be placed in CareLink iPro Clinical Management system, the experimental treatment guideline/algorithm has been programmed into the system. Providers will make treatment decisions based off of results of CGM.
Comparateur actifSelf Monitoring Blood Glucose
Subjects in the Self Monitoring Blood Glucose group will have treatment decisions based on self monitored blood glucose values and not CGM values, per current standard of care.
Continuous Glucose Monitoring with treatment algorithm
those subjects randomized to Continuous Glucose Monitoring results will be placed in CareLink iPro Clinical Management system, the experimental treatment guideline/algorithm has been programmed into the system. Providers will make treatment decisions based off of results of CGM.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
change in glycosylated hemoglobin using intensive periodic CGM monitoring vs traditional monitoring
baseline and day 187
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
change in fasting plasma glucose between two groups
baseline and day 187
comparison of change of the area under the curve for CGM results for both treatment arms
baseline and day 187
quality of life data evaluation
Provide preliminary data on the effect of CGM monitoring on subjects' quality of life.
baseline and day 187
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous

  • A subject is eligible for the study if all of the following criteria are met:

    1. Provide written informed consent prior to enrollment
    2. Is male or female between 18-70 years old
    3. Has been treated by the Principal Investigator or referring physician in the same practice.
    4. Has Type 2 Diabetes Mellitus for greater than 12 months on 1-3 antihyperglycemic medications, on a stable dose for 90 days prior to screening.
    5. Has a HbA1c between 7.5-9.0% in the 90 days prior to screening.
    6. Currently performs self-monitoring blood glucose checks at least 3 times per week.
    7. Ability to adhere to protocol requirements.

  • 1. Has Type 1 Diabetes or Gestational Diabetes

    2.Is pregnant or planning to become pregnant during the course of the study.

    3.Current use of any insulin or history of insulin use in the last 6 months.

    4.An acute coronary or cerebrovascular event in the previous 3 months.

    5.Any planned surgery during the course of the study.

    6.Current continuous renal replacement therapy.

    7.BMI ≥ 45 kg/m^2

    8.Current oral or injectable steroid use.

    9.Any previous history Continuous Glucose Monitoring use by any device or manufacturer.

    10.Has a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

University of North Carolina, Chapel Hill logoUniversité de Caroline du Nord à Chapel Hill241 essais cliniques actifs à explorer
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2 Centres de l'étude dans 1 pays

Georgia

Atlanta Diabetes Assoicates, Atlanta, Georgia, 30309, United States

North Carolina

University of North Carolina, Chapel Hill, North Carolina, 27599, United States