Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Artificial pancreas, Closed-loop system, Hypoglycemia, Insulin
Eligibility Criteria
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.
- HbA1c ≤ 12%.
Exclusion Criteria:
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
- Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
- Chronic use of acetaminophen. Acetaminophen may interfere with glucose sensor readings
- Pregnancy (ongoing or current attempt to become pregnant)
- Breastfeeding
- No nearby party for assistance if needed
- Plans to go abroad or travel at more than 2 hours distance from Montreal during the trial period
- Severe hypoglycemic episode within two weeks of screening or during the run-in period
- Severe hyperglycemic episode requiring hospitalization in the last 3 months
- Current use of glucocorticoid medication (except low stable dose and inhaled steroids)
- Known or suspected allergy to the trial products
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator
- Anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)
Sites / Locations
- Institut de recherches cliniques de Montréal
- McGill University Health Centre
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Sensor-augmented pump therapy
Single-hormone closed-loop strategy
Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.
Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.