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- Essai clinique NCT02750267
Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
22 juin 2017 mis à jour par: Mark DeBoer, MD, University of Virginia
The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Young children with Type 1 Diabetes (T1D) in the age range of 5-8 years old are a population with clear needs but unique challenges regarding the application of artificial pancreas (AP) technologies.
Young children are likely to benefit from an AP system, with current deficits in glycemic control that include both significant hypoglycemia and sub-optimal HbA1c levels; however, they have undeveloped abilities to control and interact with the AP system, posing potential safety issues.
During the hours that these children are away from their parents at school and elsewhere, they lack the sophistication to operate the currently-available tools in an AP system--and may induce harm if they are allowed to do so, causing parental resistance to AP use.
Commercially-available insulin pumps have mechanisms to lock access to children to prevent inappropriate insulin-delivery.
However, the AP is more complex than an insulin pump, both in requiring more detailed setting information (that a child could adversely alter) and in providing alerts for impending low- and high-blood glucose (BG) levels (that one wouldn't want to lock out to child use).
These functions are all run via a platform on a smart phone-a device with which young children may already feel a high degree of familiarity and thus be more likely to attempt to explore and potentially change settings.
It is likely that young children will benefit the most from a system that gives them access to some AP features but provides access to other features only for their parents.
In this sense, young children require a device that is not user-centered as much as family-centered.
A redesign of the system to provide appropriate access to AP tools-in which certain users can obtain access to certain functionalities-is direly needed before children in this age range can benefit from the improvements in blood glucose (BG) control that the AP has to offer.
Type d'étude
Interventionnel
Inscription (Réel)
12
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Virginia
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Charlottesville, Virginia, États-Unis, 22903
- University of Virginia Center for Diabetes Technology
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
5 ans à 9 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
Clinical diagnosis of type 1 diabetes,
- The diagnosis of type 1 diabetes is based on the investigator's judgment
- C peptide levels and antibody determinations are not required
- Daily insulin therapy for ≥ 12 months
- Insulin pump therapy for ≥ 3 months
- Age ≥5 - ≤8 years old
- Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
- Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
Exclusion Criteria:
The presence of any of the following is an exclusion for the study:
- Diabetic ketoacidosis in the past month
- Hypoglycemic seizure or loss of consciousness in the past 3 months
- History of seizure disorder (except for hypoglycemic seizure)
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- Cystic fibrosis
- Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- History of ongoing renal disease (other than microalbuminuria).
- Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
- Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
- Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/Hotel Admission if these criteria are not met. The study subject will not participate in the trial if these conditions are met.
Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
- Inpatient psychiatric treatment in the past 6 months
- Uncontrolled adrenal insufficiency
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Group A
In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel.
All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system).
Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission.
Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.
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All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
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Expérimental: Group B
Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission.
Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission.
As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.
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All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percent of Sensor Glucose Readings Between 70-180 mg/dL
Délai: 68 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percent of Time Sensor Glucose Readings Are <70 mg/dL
Délai: 68 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
|
Percent of Time Sensor Glucose Readings Are >150 mg/dL
Délai: 72 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
|
Percent of Time Sensor Glucose Readings Are >180 mg/dL
Délai: 68 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
|
Percent of Time Sensor Glucose Readings Are >250 mg/dL
Délai: 68 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
|
Percent of Time Sensor Glucose Readings Are >400 mg/dL
Délai: 72 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
|
Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)
Délai: 72 hours
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All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Distribution of Sensor and Meter Glucose Values (Maximum)
Délai: 72 hours
|
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Distribution of Sensor and Meter Glucose Values (Minimum)
Délai: 72 hours
|
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)
Délai: 72 hours
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All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
|
Mean BG (as Measured by CGM)
Délai: 68 hours
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All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
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Hypoglycemia Area Under the Curve <60
Délai: 72 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Hypoglycemia Area Under the Curve <70 mg/dL
Délai: 72 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Hyperglycemia Area Under the Curve >180
Délai: 72 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Hyperglycemia Area Under the Curve >250 mg/dL
Délai: 72 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL
Délai: 68 hours
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All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.
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68 hours
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End of Night Blood Glucose
Délai: 72 hours
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All subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period.
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72 hours
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Mark D. DeBoer, MD, University of Virginia, Pediatrics, Endocrinology/Diabetes
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2016
Achèvement primaire (Réel)
1 mai 2016
Achèvement de l'étude (Réel)
1 mai 2016
Dates d'inscription aux études
Première soumission
15 avril 2016
Première soumission répondant aux critères de contrôle qualité
20 avril 2016
Première publication (Estimation)
25 avril 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 juillet 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 juin 2017
Dernière vérification
1 juin 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 18888
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Not yet determined
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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