Start Date
January 31, 2018
Primary Completion Date
July 31, 2018
Study Completion Date
July 31, 2018
6-day intervention with sensor-augmented pump therapy
One day prior to the intervention, participants will have to install a glucose sensor and the study insulin pump. Participants will adjust their insulin delivery as per their standard practice; including temporary basal and correction boluses. Participants will have access to their finger-stick glucose measurements and will be advised to measure their glucose level as per their standard practice. Participants will be asked to install a new infusion set every 2 days. Participants will be allowed to eat whatever they want and allowed to drink alcohol. Participants will use sensor-augmented pump therapy for 6 days.
6-day intervention with single-hormone closed-loop strategy
One day prior to the intervention, participants will have to install a glucose sensor and the study insulin pump. On the first day of the intervention, participants will be admitted to the clinical research facility in the morning. A team member will review with the participant how to use study devices. Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be allowed to go home in the afternoon. They will be advised to continue with study intervention at home for the next 5 days. Participants will be asked to install a new infusion set every 2 days. Participants will be allowed to eat whatever they want and allowed to drink alcohol.
6-day intervention with dual-hormone closed-loop strategy
One day prior to the intervention, participants will have to install a glucose sensor and the study insulin pump. On the first day of the intervention, participants will be admitted to the clinical research facility in the morning. Participants will have to install a second pump containing glucagon. A team member will review with the participant how to use study devices. Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be allowed to go home in the afternoon. They will be advised to continue with study intervention at home for the next 5 days. Participants will be asked to install a new infusion set every 2 days. Participants will be allowed to eat whatever they want and allowed to drink alcohol.
Insulin
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)
Glucagon
Glucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy.
Continuous Glucose Monitoring System Enlite sensor®, Medtronic
Enlite sensor®, Medtronic
Insulin pump MiniMed® Paradigm® Veo™, Medtronic
MiniMed® Paradigm® Veo™, Medtronic
Institut de recherches cliniques de Montréal, Montreal
Collaborators (1)
Juvenile Diabetes Research Foundation
OTHER
Institut de Recherches Cliniques de Montreal
OTHER