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Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System (CTR) Phase I 57 À domicile Exercice

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 NCT01271023 (CTR) était conçu pour étudier le traitement de Diabète de type 1. Il s'agissait d'une étude interventionnel en Phase I. Son statut actuel est : terminé. L'étude a commencé le 1 mars 2011, avec un objectif de recruter 57 participants. Dirigée par Jaeb Center for Health Research, l'étude s'est terminée le 1 août 2012. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 9 septembre 2016.
Résumé succinct
The purpose of this study is to test an insulin management system ("Control-to-Range (CTR) system") in an inpatient setting to see if the system is safe and effective enough to test in a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines how much insulin is needed, and (3) an Insulet OmniPod ...Afficher plus
Description détaillée

Clinical Research Center (CRC) Session Detail (closed-loop control active for all elements)

Day 1 (24+ hours):

  1. Admission at 7:00 AM
  2. Standardized breakfast with normal bolus at 9:00 AM
  3. Lunch with normal bolus at 1:00 PM
  4. Dinner with normal bolus at 7:00 PM
  5. Overnight sleep
  6. Breakfast with missed meal bolus followed by user alert and correction bolus
  7. Discharge

Day 2 (24+ hours):

  1. Admission at 7:...
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Titre officiel

Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System

Pathologies
Diabète de type 1
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
  • CTR
Numéro NCT
Date de début (réel)
2011-03
Dernière mise à jour publiée
2016-09-09
Date de fin (estimée)
2012-08
Inscription (estimée)
57
Type d'étude
Interventionnel
PHASE
Phase I
Statut
Terminé
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalClosed-Loop Control
The Control to Range algorithm will be used in conjunction with continuous glucose monitoring and insulin pump delivery to manage the subject's blood glucose.
Control-to-Range Automated Insulin Management System
The devices that will be used in the Closed-Loop Control System are standardized across all study sites and include the DexCom Seven Plus Continuous Glucose Monitor (CGM), the OmniPod insulin pump, and the FreeStyle blood glucose meter. The Closed-Loop Control System will be used during all 3 admission visits.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit
Group success criterion defined as a mean blood glucose \>50%, lower end of one-sided 95% confidence interval \>40% and individual criterion of no individual \<30%.
Admission Visit 1
Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus
Success is defined as \>=40% subjects with a blood glucose in the 71-180 mg/dL range.
4 hours following the breakfast with a missed meal bolus
Percent of subjects with blood glucose reading of 71-180 mg/dL 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount
Success is defined as \>=50% subjects with a blood glucose in the 71-180 mg/dL range.
5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount
Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise
Success is defined as less than 25% of subjects with a blood glucose nadir \<=60 mg/dL.
Following exercise completion
Overall frequency of hypoglycemia
Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself.
Includes both admission visits
Overall frequency of hyperglycemia
Success defined as no subjects with diabetic ketoacidosis (DKA).
Includes both admission visits
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit
Group success criterion defined as a mean blood glucose \>50%, lower end of one-sided 95% confidence interval \>40% and individual criterion of no individual \<30%.
Admission Visit Day 1 (9:00AM-11:00PM)
Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit
Group success criterian defined as a mean blood glucose \>60%, lower end of one-sided 95% confidence interval \>50% and individual criterion of no individual \<30%.
Admission Visit Night 1 (11:00PM-8:00AM)
Percent of blood glucose values >400 mg/dL during the first admission visit
Individual success is defined as no blood glucose values \>400 mg/dL.
Admission Visit 1
Percent of blood glucose values <=60 mg/dL during the first admission visit
No more than 33% of visits with blood glucose \<=60 mg/dL
Admission Visit 1
Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus
Success is defined as less than 5% of subjects have a peak blood glucose \>400 mg/dL
4 hours following the breakfast with a missed meal bolus
Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a missed meal bolus
Success is defined as less than 15% of subjects have a nadir blood glucose \<=60 mg/dL
4 hours following the breakfast with a missed meal bolus
Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount
Success is defined as less than 5% of subjects have a peak blood glucose \>400 mg/dL
following the breakfast with a meal bolus 30% more than the recommended bolus amount
Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount
Success is defined as less than 25% of subjects have a nadir blood glucose \<=60 mg/dL
following the breakfast with a meal bolus 30% more than the recommended bolus amount
Critères d'éligibilité

Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
12 Years
Sexes éligibles
Tous
  • Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
  • Age 12 to 65 years
  • Hemoglobin A1c (HbA1c) between 5.0% and 10.5%, as measured with DCA2000 or equivalent device
  • For females, not currently known to be pregnant
  • Demonstration of proper mental status and cognition for the study
  • An understanding of and willingness to follow the protocol and sign the informed consent or assent

  • Diabetic ketoacidosis in the past 6 months

  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment

  • History of a seizure disorder (except hypoglycemic seizure). Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist treatment for a seizure disorder

  • Coronary artery disease or heart failure. Subjects with a history of coronary artery disease may be included in the study if they receive written clearance from their cardiologist

  • Cystic fibrosis

  • Active infection

  • A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:

    • Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
    • Presence of a known adrenal disorder
    • Abnormal liver or renal function (Transaminase >2 times the upper limit of normal, Creatinine > 1.5 mg/dL)
    • Active gastroparesis
    • If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
    • Uncontrolled thyroid disease
    • Abuse of alcohol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
  • A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol

  • Current use of a beta blocker medication

  • Hematocrit <30% (labs drawn at screening visit or within one month prior to screening for other purposes will suffice for enrollment purposes related to hematocrit)

  • Use of pseudoephedrine 48 hours prior to Clinical Research Center (CRC) admission

Jaeb Center for Health Research logoJaeb Center for Health Research
Partie responsable de l'étude
John Lum, Investigateur principal, Principal Investigator, Jaeb Center for Health Research
Aucune donnée de contact disponible
7 Centres de l'étude dans 4 pays
Montpellier University Hospital, Montpellier, 34295, France

California

Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
Stanford University, Stanford, California, 94305, United States

Colorado

University of Colorado Health Sciences Center- Barbara Davis, Aurora, Colorado, 80045, United States

Virginia

University of Virginia, Charlottesville, Virginia, 22908, United States
Schneider Children's Medical Center of Israel, Petah Tikva, 49202, Israel
University of Padova, Padova, 93106, Italy