Closed-loop Control of Glucose Levels (Artificial Pancreas) for 15 Weeks in Adolescents and Adults With Type 1 Diabetes
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Closed-loop system, Artificial pancreas, Type 1 diabetes, Hypoglycemia, Insulin, Glucagon
Eligibility Criteria
Inclusion Criteria:
- Males and females ≥ 12 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 ≤ 11%.
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.
- History of pheochromocytoma or insulinoma (glucagon could induce a hormonal response of these tumors)
- Beta-blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses)
- Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose)
- Chronic acetaminophen treatment (can interfere with glucose sensor measurements)
- Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
- Anticholinergic drug (risk of interaction)
- Pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- 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.
- Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
- Treatments that could interfere with glucagon
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Sensor-augmented pump therapy
Single-hormone closed-loop strategy
Dual-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.
Variable subcutaneous insulin and glucagon mini-boluses will be infused using two separate subcutaneous infusion pumps to regulate glucose levels (MiniMed® Paradigm® Veo™, Medtronic). Participant's usual fast-acting insulin analog and Glucagon (Eli Lilly) will be used. Every 10 minutes, the glucose level 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 pumps. Newly reconstituted glucagon will be used every 24 hours.