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Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels

25 avril 2018 mis à jour par: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

An Open-label, Double-blind, Randomized, Two-way, Cross-over Pilot Study to Provide Preliminary Evidence of the Efficacy of Rapid-acting Aspart Compared to Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels in Adults With Type 1 Diabetes

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings.

The objective of this pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect.

Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.

Aperçu de l'étude

Statut

Retiré

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Phase

  • Phase 2

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:

  1. Males and females ≥ 18 years of old.
  2. Clinical diagnosis of type 1 diabetes for at least one year.
  3. The subject will have been on insulin pump therapy for at least 6 months.
  4. HbA1c ≤ 12%.

Exclusion Criteria:

  1. Using a patch-pump (e.g. Omnipod)
  2. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  3. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  4. Ongoing or planned pregnancy.
  5. Breastfeeding.
  6. Severe hypoglycemic episode within two weeks of screening.
  7. Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
  8. Known or suspected allergy to the trial products or meal contents.
  9. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  10. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
  11. Problems with venous access.

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 croisée
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
Dispositif: Insulin pump
The participant's insulin pump will be used to infuse insulin
Dispositif: Continuous glucose monitoring system
The Dexcom G4 Platinum will be used to measure glucose levels
Autre: 11-hour intervention with the single-hormone artificial pancreas

Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations.

At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits.

Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes.
Comparateur actif: Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
Dispositif: Insulin pump
The participant's insulin pump will be used to infuse insulin
Dispositif: Continuous glucose monitoring system
The Dexcom G4 Platinum will be used to measure glucose levels
Autre: 11-hour intervention with the single-hormone artificial pancreas

Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations.

At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits.

Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Change in plasma glucose levels 1 hour after the meal
Délai: 1 hour
1 hour

Mesures de résultats secondaires

Mesure des résultats
Délai
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
Délai: 1 hour
1 hour
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
Délai: 2 hours
2 hours
Plasma glucose level 1 hour after the meal.
Délai: 1 hour
1 hour
Plasma glucose level 2 hours after the meal.
Délai: 2 hours
2 hours
Glycemic peak in the 3 hours following the meal.
Délai: 3 hours
3 hours
Change in plasma glucose levels 2 hours after the meal.
Délai: 2 hours
2 hours
Peak time of glucose levels over the 4 hours following the meal.
Délai: 4 hours
4 hours
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
Délai: 4 hours
4 hours
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of plasma glucose levels below 3.9 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of sensor glucose levels below 3.9 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of plasma glucose levels below 3.3 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of sensor glucose levels below 3.3 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of plasma glucose levels below 2.8 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of sensor glucose levels below 2.8 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of plasma glucose levels above 10 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of sensor glucose levels above 10 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of plasma glucose levels above 13.9 mmol/L
Délai: 11 hours
11 hours
Percentage of time of sensor glucose levels above 13.9 mmol/L
Délai: 11 hours
11 hours
Percentage of time of plasma glucose levels above 16.7 mmol/L.
Délai: 11 hours
11 hours
Percentage of time of sensor glucose levels above 16.7 mmol/L.
Délai: 11 hours
11 hours
Area under the curve of plasma glucose levels below 3.9 mmol/L.
Délai: 11 hours
11 hours
Area under the curve of sensor glucose levels below 3.9 mmol/L.
Délai: 11 hours
11 hours
Area under the curve of plasma glucose levels below 3.3 mmol/L.
Délai: 11 hours
11 hours
Area under the curve of sensor glucose levels below 3.3 mmol/L.
Délai: 11 hours
11 hours
Area under the curve of plasma glucose levels below 2.8 mmol/L.
Délai: 11 hours
11 hours
Area under the curve of sensor glucose levels below 2.8 mmol/L.
Délai: 11 hours
11 hours
Area under the curve of plasma glucose levels above 10.0 mmol/L.
Délai: 11 hours
11 hours
Area under the curve of sensor glucose levels above 10.0 mmol/L.
Délai: 11 hours
11 hours
Area under the curve of plasma glucose levels above 13.9 mmol/L.
Délai: 11 hours
11 hours
Area under the curve of sensor glucose levels above 13.9 mmol/L.
Délai: 11 hours
11 hours
Area under the curve of plasma glucose levels above 16.7 mmol/L.
Délai: 11 hours
11 hours
Area under the curve of sensor glucose levels above 16.7 mmol/L.
Délai: 11 hours
11 hours
Standard deviation of plasma glucose levels.
Délai: 11 hours
11 hours
Standard deviation of sensor glucose levels.
Délai: 11 hours
11 hours
Coefficient of variance of plasma glucose levels.
Délai: 11 hours
11 hours
Coefficient of variance of sensor glucose levels.
Délai: 11 hours
11 hours
Total insulin delivery.
Délai: 11 hours
11 hours
Mean plasma glucose level.
Délai: 11 hours
11 hours
Mean sensor glucose level.
Délai: 11 hours
11 hours
Mean plasma insulin concentration.
Délai: 11 hours
11 hours
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
Délai: 11 hours
11 hours

Collaborateurs et enquêteurs

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

Parrainer

Institut de Recherches Cliniques de Montreal

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 (Anticipé)

1 avril 2018

Achèvement primaire (Anticipé)

31 décembre 2018

Achèvement de l'étude (Anticipé)

31 décembre 2018

Dates d'inscription aux études

Première soumission

3 novembre 2017

Première soumission répondant aux critères de contrôle qualité

3 novembre 2017

Première publication (Réel)

7 novembre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 avril 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 avril 2018

Dernière vérification

1 avril 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CLASS-FiAsp

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

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 .

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