Safety and Efficacy of Artificial Pancreas With and Without a Meal Detection Module on Glycemic Control in Adolescents With Type 1 Diabetes After a Missed Bolus
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, Artificial Pancreas, Closed-Loop Delivery, Insulin, Adolescent, Missed Bolus
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of type 1 diabetes for at least 12 months. (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
- The participant will have been on insulin pump therapy for at least 3 months.
- HbA1c 7.5% to 12%.
- Self-reported or documented history of missed-bolus for meals during the previous 6 months.
Exclusion Criteria:
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Severe hypoglycemic episode within one month of screening.
- Pregnancy.
- Current use of oral glucocorticoid medication (except low stable dose). Stable doses of inhaled steroids are acceptable.
- Known or suspected allergy to the trial products, including the meal content.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).
Sites / Locations
- McGill University Health Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Closed Loop Delivery
Closed Loop Delivery with Meal Detection Module
Conventional Pump Therapy
Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm. Participants will eat breakfast and bolus, then eat lunch and not bolus.
Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm with an overlying meal detection module which detects missed meals and will increase insulin infusion rates based on a predictive meal detection algorithm. Participants will eat breakfast and bolus, then eat lunch and not bolus.
Insulin will be delivered by subcutaneous insulin infusion pump with participants usual infusion rate. Participants will eat breakfast and bolus as per usual, then eat lunch and not bolus.