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Continuous Glucose Monitoring to Measure Effect of Glycemic Index 7

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 NCT01145547 a été une étude interventionnel pour Diabète sucré de type 1. Son statut actuel est : terminé. L'étude a commencé le 1 avril 2009, avec un objectif de recruter 7 participants. Dirigée par Legacy Health System, l'étude s'est terminée le 1 octobre 2009. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 23 octobre 2015.
Résumé succinct
Background: Post-prandial hyperglycemia is common in people with type 1 diabetes.

Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring.

Design: Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, bo...

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Description détaillée
A total of 14 diet studies (each with two meals) were completed in three men and four women. All subjects completed two diet studies in which two meals were served 195 minutes apart. On one study day, two high GI (> 75) meals were given, and on the other study day, two low GI (< 30) meals were given. The low GI and high GI meals were matched for amount of carbohydrates, protein, and fat based on a weight-maintainin...Afficher plus
Titre officiel

The Effect of Glycemic Index on Post-prandial Glycemia (Breakfast vs. Lunch) in Patients With Type 1 Diabetes: Quantification With Continuous Glucose Monitoring

Pathologies
Diabète sucré de type 1
Autres identifiants de l'étude
  • kw01
Numéro NCT
NCT01145547
Date de début (réel)
2009-04
Dernière mise à jour publiée
2015-10-23
Date de fin (estimée)
2009-10
Inscription (estimée)
7
Type d'étude
Interventionnel
PHASE
N/A
Statut
Terminé
Mots clés
glycemic index
Diabetes Mellitus
continuous glucose monitoring
Objectif principal
Soins de soutien
Méthode d'allocation
Randomisé
Modèle d'intervention
Étude croisée
Masquage
Simple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Comparateur actiflow glycemic index effect on post-prandial peak
Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
Dexcom Seven® Plus Continuous Glucose Monitoring sensor
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
Comparateur actifhigh glycemic index effect on post-prandial peak
Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
Dexcom Seven® Plus Continuous Glucose Monitoring sensor
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Mean Area Under the Curve for Rise in Breakfast Post-prandial.
Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals.
Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast
Critères d'éligibilité

Âges éligibles
Enfant, Adulte, Adulte âgé
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
  • clinical diagnosis of type 1 diabetes mellitus
  • patients on insulin pump therapy

Any patient who was

  • pregnancy
  • cardiovascular, cerebrovascular, kidney, or liver disease
  • uncontrolled chronic medical conditions
  • oral or parenteral corticosteroid use
  • immunosuppressant use
  • visual or physical impairments that impede the use of a continuous glucose monitoring device
  • insulin or glucagon allergy
  • hypoglycemia unawareness
  • requirement of greater than 200 units of insulin per day
  • gastroparesis
  • any prior gastric surgery
  • an allergy to any food items served.
Legacy Health System logoLegacy Health System
Juvenile Diabetes Research Foundation logoJuvenile Diabetes Research Foundation
Partie responsable de l'étude
W. Kenneth Ward, Investigateur principal, Senior Scientist, Legacy Health System
Aucune donnée de contact disponible
1 Centres de l'étude dans 1 pays

Oregon

Legacy Health System--Holladay Park Campus, Portland, Oregon, 97232, United States