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MD Logic Pump Advisor- Adults Study

10 janvier 2017 mis à jour par: Rabin Medical Center

Evaluation of Automated Insulin Pump Settings Using the MD-Logic Pump Advisor-Adults Sub Study

Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to the standard of care of patients with type 1 diabetes.

The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.

The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

the MD-Logic Pump Advisor was design by the Diabetes Technology Center, the Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel. The MD-Logic Pump Advisor learns and adapts the patient's insulin pump settings in order to optimize glucose control. The MD-Logic Pump Advisor needs, as input, sensor readings, insulin delivery and recording of the meals during home care. During collection of the data, the patients are asked to continue their daily routine (no need for special consideration).

The present study was designed to test the automatic algorithm that will evaluate and change, when necessary, the patient's insulin pump settings based on prior sensor reading, insulin delivery, and meals data that was collected while the patient is under his regular treatment at home.

The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.

The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.

The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).

Endpoints:

  • Primary endpoint Increase in time spent in the normal range, defined as sensor glucose level within 70 to 180 mg/dl
  • Secondary endpoints Reduced time spent above 180 mg/dl, reduced time spent below 70 mg/dl, reduced number of hypoglycemic events below 63 mg/dl, reduced glucose variability, quality of life measurements and subject treatment satisfaction.

Inclusion Criteria:

  • Subject with Type 1 diabetes (>1yr since diagnosis)
  • Medtronic ( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII (continuous subcutaneous insulin infusion) therapy for at least 3 months
  • Age ≥ 18 years
  • HbA1c at inclusion ≥ 6.0%
  • No concomitant diseases that influence metabolic control
  • No current use of CGM
  • Subjects do not participate in any other interventional study

Type d'étude

Interventionnel

Inscription (Réel)

18

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

  • Israël
      • Petaach-Tikva, Israël, 49202
        • Schneider Children's Medical Center
  • Slovénie
      • Ljubljana, Slovénie
        • University Children's Hospital

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 à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Subject with Type 1 diabetes (>1yr since diagnosis)
  2. Medtronic( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII therapy for at least 3 months
  3. Age ≥ 18 years
  4. HbA1c at inclusion ≥ 6.0%
  5. No concomitant diseases that influence metabolic control
  6. No current use of CGM
  7. Subjects do not participate in any other interventional study

Exclusion Criteria:

  1. Known or suspected allergy to trial products.
  2. Any significant diseases or conditions including psychiatric disorders and substance abuse that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study, or compromise patient safety
  3. Subject is currently using CGM device
  4. Diabetic ketoacidosis in the past 3 months.
  5. Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment.
  6. Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
  7. Subject is participating in another drug or device study that could affect glucose measurements or glucose management.
  8. Female subject who is pregnant or planning to become pregnant within the planned study duration

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: intervantion group
Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor.
Dispositif: MD Logic Pump Advisor
Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor
Aucune intervention: control group
Regular treatment, No change will be made in the insulin pump setting during the study(unless there is a medical need or any safety concern).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Time spent in the normal range
Délai: during each 6 days iteration
increase in the time spent in the normal range, defined as sensor glucose level within 70-180 mg/dl
during each 6 days iteration

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
number of iterations required to achieve the maximal meaningful improvement in the primary outcome
Délai: Day 78
number of iterations required to achieve the maximal meaningful improvement in the primary outcome
Day 78
time spent above 180 mg/dl
Délai: during each 6 days iteration
time spent above 180 mg/dl
during each 6 days iteration
time spent below 70 mg/dl
Délai: during each 6 days iteration
time spent below 70 mg/dl
during each 6 days iteration
Number of Hypoglycemic events below 63 mg/dl
Délai: during each 6 days iteration
Number of Hypoglycemic events below 63 mg/dl
during each 6 days iteration
Adverse event
Délai: during each 6 days iteration
Adverse event
during each 6 days iteration
glucose variability- area under the curve
Délai: during each 6 days iteration
glucose variability measured as area under the curve (the area between the measured blood glucose and the glucose level of 180 mg/dl) and area above the curve (the area between the measured blood glucose and the glucose level of 70 mg/dl
during each 6 days iteration
Quality of Life Questionaires
Délai: At the end of the study- day 30 -78
Quality of Life Questionaires
At the end of the study- day 30 -78
Number of MDLAP-recommendations that were rejected by the physician
Délai: during each 6 days iteration
Number of MDLAP-recommendations that were rejected by the physician
during each 6 days iteration
Number and type of changes in any pump setting per iteration
Délai: during each 6 days iteration
Number and type of changes in any pump setting per iteration
during each 6 days iteration

Collaborateurs et enquêteurs

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

Parrainer

Rabin Medical Center

Collaborateurs

Medtronic

Les enquêteurs

  • Chercheur principal: Moshe Phillip, Prof, Schenider Children's Medical

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 juillet 2010

Achèvement primaire (Réel)

1 juillet 2016

Achèvement de l'étude (Réel)

1 juillet 2016

Dates d'inscription aux études

Première soumission

27 juin 2010

Première soumission répondant aux critères de contrôle qualité

4 juillet 2010

Première publication (Estimation)

7 juillet 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

11 janvier 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 janvier 2017

Dernière vérification

1 janvier 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • rmc005816ctil

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