Effect of the InsuPatch on Automated Closed-loop Glucose Control in Type 1 Diabetes

This is an open-label, single-center, randomized crossover study evaluating the performance
of a closed-loop (CL) insulin delivery system using a subcutaneous glucose sensor and an
external insulin pump comparing the peak post-prandial glucose levels and the post-prandial
glucose AUC during either CL control alone or CL control with the InsuPatch in an inpatient
hospital research unit (HRU) setting. The closed loop visit consists of approximately 67
hours over 4 days and 3 nights.

Inclusion Criteria:

1. age 12-40 years

2. clinical diagnosis of type 1 diabetes

3. duration of type 1 diabetes ≥ 1 year

4. HbA1c ≤ 9 %

5. Treated with pump therapy for at least 3 months

6. Body weight > 40 kg

Exclusion Criteria:

1. Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study
enrollment

2. Presence of any medical or psychiatric disorder that may interfere with subject
safety or study conduct

3. Use of any medications (besides insulin) known to blood glucose levels, including
oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal
corticosteroid use is allowed along as not given within 4 weeks of admission. Use of
topical glucocorticoids is allowable as long as affected skin area does not overlap
with study device sites. Subjects using herbal supplements will be excluded, due to
the unknown effects of these supplements on glucose control

4. History of poor wound healing, heat sensitivity, or diminished skin integrity.

5. History of hypoglycemic seizure within last 3 months

6. Anemic (low hematocrit), or evidence of renal insufficiency (elevated serum
creatinine)

7. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy

8. Subjects unable to give consent / permission / assent