Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
8 février 2019 mis à jour par: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults With Type 1 Diabetes
Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.
The artificial pancreas 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 artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.
The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
37
Phase
- Phase 2
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
-
-
Quebec
-
Montreal, Quebec, Canada, H2W 1R7
- Institut de recherches cliniques de Montréal
-
-
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:
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 3 months) HbA1c ≤ 12%.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Use of medication with an effect on heart rate (e.g. beta-blockers).
- Abnormal blood panel and/or anemia.
- Ongoing or planned pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
- 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: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Unannounced exercise
The target blood glucose of the algorithm will be as usual.
A pre-meal full insulin bolus will be given.
|
L'analogue d'insuline à action rapide habituel du patient sera utilisé.
Le capteur de glucose Dexcom G4 Platinum sera utilisé pour mesurer les niveaux de glucose.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
|
Comparateur actif: Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
|
L'analogue d'insuline à action rapide habituel du patient sera utilisé.
Le capteur de glucose Dexcom G4 Platinum sera utilisé pour mesurer les niveaux de glucose.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
|
Comparateur actif: Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
|
L'analogue d'insuline à action rapide habituel du patient sera utilisé.
Le capteur de glucose Dexcom G4 Platinum sera utilisé pour mesurer les niveaux de glucose.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Délai: From 9:30 to 11:30 (120 minutes)
|
From 9:30 to 11:30 (120 minutes)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Relative decrease in glucose levels during exercise compared to pre-breakfast levels
Délai: From 8:00 to 10:50 (170 minutes)
|
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise
|
From 8:00 to 10:50 (170 minutes)
|
|
Number of patients experiencing exercise-induced hypoglycemia requiring treatment
Délai: From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
|
Decremental area under the curve from the start of the exercise
Délai: From 9:30 to 11:00 (90 minutes)
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From 9:30 to 11:00 (90 minutes)
|
|
|
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Délai: From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
|
Percentage of time of plasma glucose levels spent below 3.3 mmol/L
Délai: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent below 2.8 mmol/L
Délai: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L
Délai: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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|
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Percentage of time of plasma glucose levels spent above 10 mmol/L
Délai: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
|
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Percentage of time of plasma glucose levels spent above 13.9 mmol/L
Délai: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
|
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Percentage of time of plasma glucose levels spent above 16.7 mmol/L
Délai: From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
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Mean plasma glucose levels
Délai: From 8:00 to 11:30 (210 minutes)
|
From 8:00 to 11:30 (210 minutes)
|
|
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Standard deviation of glucose levels
Délai: From 8:00 to 11:30 (210 minutes)
|
From 8:00 to 11:30 (210 minutes)
|
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Coefficient of variation of glucose levels
Délai: From 8:00 to 11:30 (210 minutes)
|
From 8:00 to 11:30 (210 minutes)
|
|
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Mean time (minutes) to the first hypoglycemic event
Délai: From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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 septembre 2016
Achèvement primaire (Réel)
1 décembre 2018
Achèvement de l'étude (Réel)
1 décembre 2018
Dates d'inscription aux études
Première soumission
1 août 2016
Première soumission répondant aux critères de contrôle qualité
1 août 2016
Première publication (Estimation)
4 août 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 février 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 février 2019
Dernière vérification
1 février 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Maladies du système immunitaire
- Maladies auto-immunes
- Maladies du système endocrinien
- Diabète sucré
- Diabète sucré, type 1
- Agents hypoglycémiants
- Effets physiologiques des médicaments
- Hormones, substituts hormonaux et antagonistes hormonaux
- Insuline
- Insuline, Globine Zinc
- Les hormones
Autres numéros d'identification d'étude
- CLASS-16
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
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