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Initial Testing of the Diabeloop Algorithm in T1D Patients on Pump Therapy Over the Prandial Period and Physical Activity. (DiabeloopWP6-0)

Development of the Glycemic Control Algorithm, in Prandial and Physical Effort Situations.

The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients.

The study will be conducted in 18 patients. The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

  • Grenoble and Toulouse will test the prandial algorithm with several carbohydrate intake and a primer of 50% or 75% of the total bolus. Groups of patients are described as follows:

    • Group I: patients have a meal with the usual carbohydrate intake. The meal bolus is made according to the current treatment.
    • Group II: patients have a meal with a "low" carbohydrate intake (50% reduction of carbohydrate).
    • Group III: patients have a meal with a "strong" carbohydrate intake (increase 50% of carbohydrate).
    • Group IV: patients of group IV have each meal with carbohydrate intake but their usual bolus will be omitted.
    • Inclusion visit V1: The study will be proposed at the patients who meet the inclusion criteria. After signing the consent, the investigator shall designate one group for each patient.
    • Visit V2 (24 hours before the visit V3): Installation, calibration and education of two glucose sensors dexcom G4 ™ will be performed by a nurse. The patient will keep two sensors until the end of the study (end of V4).
    • Visit V3 (algorithm test): Patient will be fitted with its insulin pump and the two sensors dexcom G4 ™. These will be coupled by the engineer LETI to the computer on which is installed the control algorithm to be tested. Lunch will be taken at 1 pm. The algorithm will provide proposals insulin every 15 minutes until 6 pm.
    • Visit V4 (patient control): Patient will be fitted with two sensors dexcom G4 ™ and its insulin pump programmed according to the usual algorithm. The meal will be taken at 1h PM. Patient can leave the site at 6 pm after removal of sensors.
  • CHSF (Centre Hospitalier Sud Francilien) will test the algorithm glycemic control during physical activity of moderate (50% VO2max) or high intensity (75% VO2max) for 30 minutes on a bicycle ergometer. In different situations, three patient groups will be created:

    • Group A: Patients practice an "average" physical activity(50% VO2max) with usual temporary basal reduction (usually 50% of reduction during the test and 2h next).
    • Group B: Patients practice an "intense" physical activity (75% VO2max) with usual temporary basal reduction (usually 80% of reduction during the test and 2h after).
    • Group C: patients practice an "average" physical activity (50% VO2max) but without concomitant reduction of temporary basal.
    • Inclusion visit V1 : The study will be proposed at the patients who meet the inclusion criteria. After signing the consent, the investigator shall designate one group for each patient.
    • Visit V2 : Patient will be equipped with two sensors dexcom G4 ™ and a heart rate monitor. Calibrated meal is expected at 11h 30 pm. The patient will be administered his insulin dose according to his usual algorithm. The physical test will begin three hours after the meal. It will be carried on bicycle ergometer for 30 minutes at an medium or high intensity. (Average = 50% VO2max, or high level = 75% VO2max).
    • Visit V3: The same test is repeated for each patient during this visit. Its insulin pump will be controlled by the doses proposal of the algorithm after manual validation by the investigator. These will continue until the next morning, and the patient will spend overnight in the hospital.

Type d'étude

Interventionnel

Inscription (Réel)

18

Phase

  • Phase 3

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

      • Evry, France, 91058
        • Centre Hospitalier Sud Francilien
      • Grenoble, France, 38043
        • University Hospital of Grenoble
      • Toulouse, France, 31403
        • University Hospital of Toulouse

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Patients with type 1 diabetes treated by external insulin pump;
  • Patients with HbA1c <8.5%.
  • Patients aged 18 years or less;
  • Patient who signed consent;
  • Patient affiliated with Social Security.

For Grenoble and Toulouse Centers (Prandial algorithm test : MEAL):

  • Patient is practicing functional insulin therapy is a fixed meal plan.

For CHSF center (test of algorithm during activity):

  • Patient able to perform moderate or intense activity during 30 minutes.

Exclusion Criteria:

  • Patients with type 2 diabetes
  • All serious diseases that could interfere with the study
  • Insulin resistance and obesity (BMI> 30 kg/m2 and / or insulin requirements> 2 U / kg / day)

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: Recherche sur les services de santé
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Proposed treatment by Diabeloop algorithm
the insulin dose is calculated by the algorithm based on the usual treatment of the patient, the ratio I / C, the intensity of physical activity and blood glucose sensor.
the intervention is applied only at the dose of insulin
Aucune intervention: usual treatment

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Time spent in glucose reference intervals
Délai: After the end of the tests
After the end of the tests

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Measuring glucose sensor 2h, 3h and 4h post-prandial and AUC, in every situation tested to evaluate the efficacy and safety (time spent in hypoglycemia)
Délai: After the end of the tests
To evaluate the efficacy and safety of prandial algorithm, informed carbohydrate intake by the patient either quantitatively or semi-quantitative, or not informed way.
After the end of the tests

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Comparison of glucose sensor 2h, 3h and 4h post-prandial and AUC in conditions identical meals for each trigger level (50 or 75%). Measuring AUC during and 2 hours after physical activity, then to lunch time, during dinner and throughout the night.
Délai: After the end of the tests
  1. Comparison of glucose sensor 2h, 3h and 4h post-prandial and AUC, in conditions identical meals for each trigger level (50 or 75%).
  2. Comparison of blood glucose 2h, 3h and 4h post-prandial and AUC, in conditions identical meals for each trigger level, in three configurations: quantitative, semi-quantitative and bolus omitted.
  3. Measuring AUC, during and 2 hours after physical activity, then to lunch time, during dinner and throughout the night;
  4. Measure the time spent in hypoglycemia (<0.70 g / l)
  5. Measuring the number of carbohydrate ingested
After the end of the tests

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Guillaume CHARPENTIER, MD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
  • Chercheur principal: Sylvia Franc, MD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
  • Chercheur principal: Pierre-Yves BENHAMOU, Pr., CHU of Grenoble

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 mars 2013

Achèvement primaire (Réel)

1 juin 2013

Achèvement de l'étude (Réel)

1 juillet 2013

Dates d'inscription aux études

Première soumission

18 décembre 2012

Première soumission répondant aux critères de contrôle qualité

18 décembre 2012

Première publication (Estimation)

21 décembre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

27 octobre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 octobre 2014

Dernière vérification

1 octobre 2014

Plus d'information

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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