- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00831389
Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia (ePID-03)
9 novembre 2017 mis à jour par: Medtronic Diabetes
The purpose of the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop insulin delivery system using a subcutaneous glucose sensor and an external insulin pump and comparing it to an open-loop delivery system during aerobic exercise.
Subject participation will be for a maximum of 16 weeks including an outpatient study (up to 6 days) and two inpatient studies (one closed-loop; the other open-loop).
The closed- and open-loop visit consists of approximately 67 hours over 4 days and 3 nights.
Type d'étude
Interventionnel
Inscription (Réel)
13
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
-
-
Connecticut
-
New Haven, Connecticut, États-Unis, 06519
- Yale Pediatrics Diabetes Research
-
-
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
12 ans à 30 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Male and female subjects between 12-30 years of age.
- Subjects must weigh at least 50 kg to accommodate phlebotomy.
- Previously diagnosed Type 1 Diabetes Mellitus
- Diabetes duration at least 1 year.
- Currently treating their diabetes with an insulin pump.
- A1C of ≤ 9.0 % at time of enrollment.
- Willing to have an intravenous (IV) line inserted for frequent blood sampling and infusion of glucose if needed.
- Willing to wear two (2) subcutaneous glucose sensors and two (2) transmitters simultaneously during closed-loop portion of the study.
- Be in good general health without other acute or chronic illnesses except treated hypothyroidism or celiac disease and asthma not requiring glucocorticoid use.
- Able to tolerate a 75-minute exercise period of moderate intensity.
- Speak and understand English.
- Subject and parent (if minor) must be able to comprehend and sign the informed consent form and other study documents.
Exclusion Criteria:
- Pregnancy (urine pregnancy test) or lactation, if female.
- Subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data.
- Subject has a cardiac pacemaker or similar device that may be sensitive to radio frequency telemetry.
Subject using any of the following medications:
- glucocorticoids
- cyclosporine
- L-asparaginase
- niacin
- protease inhibitors
- anti-psychotics
- GnRH agonists
- beta-blockers
- calcium channel blockers
- immunosuppressants
- over-the-counter medications that may effect glucose metabolism.
Subject has any of the following conditions
- insulin allergy
- severe insulin resistance
- exercise-induced asthma
- musculoskeletal problems that may impact ability to complete exercise protocol
- substance abuse
- skin ulcers or poor wound healing
- bleeding disorders
- chronic infections
- eating disorders
- give a history of or are predisposed to major stress
- any other major organ system disease.
- Subject has experienced two (2) or more severe hypoglycemic events -seizures/coma requiring assistance in the past six (6) months.
- Subject has any other condition that in the investigator's opinion warrants exclusion from the study or precludes him/her from completing the protocol.
- Subjects using dietary supplements within 14 days of study enrollment
- Subject is currently enrolled in another study.
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: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Closed Loop (CL) Phase
|
Insulin pump controlled by closed loop unit and algorithm
|
Aucune intervention: Standard of Care (OL) Phase
Standard of Care (OL) Phase or Open Loop Phase
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Plasma Glucose (PG) Response to Exercise
Délai: Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
|
PG at start of exercise minus the subsequent PG nadir
|
Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
|
Incidence of Hypoglycemia Immediately Following Exercise
Délai: Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.
|
Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL.
Maximum tally of hypoglycemic events within any 30 minute period is 1.
|
Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.
|
Incidence of Nocturnal Hypoglycemia Following Exercise
Délai: Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.
|
Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL.
Maximum tally of hypoglycemic events within any 30 minute period is 1.
|
Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Peak Post-prandial Plasma Glucose (PG)
Délai: Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.
|
For each subject and study phase, the six peak PG following each of the six meals were determined.
The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase.
|
Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.
|
Nadir Plasma Glucose (PG) Immediately Following Exercise
Délai: Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
|
The PG nadir observed following the start of exercise
|
Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
|
Overnight Nadir Plasma Glucose (PG)
Délai: Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.
|
For each subject and study phase, the overnight nadir PG for each of two nights were determined.
The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase.
|
Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.
|
Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.
Délai: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
|
For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL.
Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
|
Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
|
Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.
Délai: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
|
For each subject and study phase, the percentage of the PG curve > 180 mg/dL.
Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
|
Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
|
Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range.
Délai: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
|
For each subject and study phase, the percentage of the PG curve < 70 mg/dL.
Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
|
Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Stuart Weinzimer, MD, Yale University
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 janvier 2009
Achèvement primaire (Réel)
1 novembre 2010
Achèvement de l'étude (Réel)
1 novembre 2010
Dates d'inscription aux études
Première soumission
26 janvier 2009
Première soumission répondant aux critères de contrôle qualité
26 janvier 2009
Première publication (Estimation)
28 janvier 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 décembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 novembre 2017
Dernière vérification
1 novembre 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ePID-03
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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 .
Essais cliniques sur Diabète sucré de type 1
-
Eledon PharmaceuticalsRetiréDiabète sucré de type 1 fragileÉtats-Unis
-
Ain Shams UniversityInconnueDiabète sucré de type 1 avec hypoglycémie | diabète de type 1Egypte
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)ComplétéDiabète sucré de type 1 | DT1 | DT1 | Diabète sucré de type 1 d'apparition récenteÉtats-Unis, Australie
-
Medical College of WisconsinRecrutementDiabète de type 1 | Diabète sucré de type 1 | diabète de type 1États-Unis
-
Spiden AGDCB Research AGRecrutementDiabète sucré de type 1 | Diabète sucré de type 1 avec hypoglycémie | Diabète sucré de type 1 avec hyperglycémieSuisse
-
Shanghai Changzheng HospitalRecrutementDiabète sucré de type 1 fragileChine
-
Instytut Diabetologii Sp. z o.o.National Center for Research and Development, Poland; Nalecz Institute of...InconnueDiabète sucré de type 1 avec hyperglycémie | Diabète sucré de type 1 avec hypoglycémiePologne
-
Capillary Biomedical, Inc.ComplétéDiabète sucré, type 1 | Diabète de type 1 | Diabète sucré de type 1 | Diabète sucré, dépendant de l'insuline, 1Australie
-
Poznan University of Medical SciencesInconnueDiabète sucré de type 1 | Rémission du diabète de type 1 | Complications chroniques du diabètePologne
-
Capillary Biomedical, Inc.RésiliéDiabète de type 1 | Diabète sucré de type 1 | Diabète sucré, type I | Diabète sucré, dépendant de l'insuline, 1 | IDDML'Autriche
Essais cliniques sur Closed Loop
-
University of CambridgeCambridge University Hospitals NHS Foundation TrustComplétéTroubles du métabolisme du glucose | Maladies auto-immunes | Diabète sucré | Maladies du système endocrinien | Diabète sucré, type 1Royaume-Uni
-
Spry HealthUniversity of California, San FranciscoComplété
-
Fundación Instituto de Estudios de Ciencias de...Instituto de Salud Carlos III; Spanish Society of Cardiology; Sanidad de Castilla...Actif, ne recrute pasInfarctus du myocarde | Mort subite | Tachycardie ventriculaire | Utilisateur de défibrillateur implantable | Dysfonctionnement myocardiqueEspagne
-
University of TurkuAcademy of Finland; Juho Vainio Foundation; Ministry of Education and Culture...ComplétéExercer | Vieillissement | RetraiteFinlande
-
Liverpool John Moores UniversityAlder Hey Children's NHS Foundation TrustRecrutementObésité, AdolescentRoyaume-Uni
-
Kansas City Heart Rhythm Research FoundationRecrutementSténose aortique | Bloc cardiaque | Nouvelle apparition de la fibrillation auriculaireÉtats-Unis
-
University of LouisvilleRetiréMaladies urologiques | Système urologique Complication de la procédure
-
University Health Network, TorontoUniversity of TorontoComplétéCancer du sein | Fatigue | Activité physique | Cancer de la prostate | Comportement sédentaireCanada
-
Hospital Universitario de FuenlabradaRecrutementCancer de la vessie | Carcinome urothélial récurrent | Carcinome urothélial de la vessie | Néoplasme de la vessie | Stade du cancer de la vessieEspagne
-
Zagazig UniversityComplété