Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform

Young children with Type 1 Diabetes (T1D) in the age range of 5-8 years old are a population
with clear needs but unique challenges regarding the application of artificial pancreas (AP)
technologies. Young children are likely to benefit from an AP system, with current deficits
in glycemic control that include both significant hypoglycemia and sub-optimal HbA1c levels;
however, they have undeveloped abilities to control and interact with the AP system, posing
potential safety issues. During the hours that these children are away from their parents at
school and elsewhere, they lack the sophistication to operate the currently-available tools
in an AP system--and may induce harm if they are allowed to do so, causing parental
resistance to AP use. Commercially-available insulin pumps have mechanisms to lock access to
children to prevent inappropriate insulin-delivery. However, the AP is more complex than an
insulin pump, both in requiring more detailed setting information (that a child could
adversely alter) and in providing alerts for impending low- and high-blood glucose (BG)
levels (that one wouldn't want to lock out to child use). These functions are all run via a
platform on a smart phone—a device with which young children may already feel a high degree
of familiarity and thus be more likely to attempt to explore and potentially change
settings. It is likely that young children will benefit the most from a system that gives
them access to some AP features but provides access to other features only for their
parents. In this sense, young children require a device that is not user-centered as much as
family-centered. A redesign of the system to provide appropriate access to AP tools—in which
certain users can obtain access to certain functionalities—is direly needed before children
in this age range can benefit from the improvements in blood glucose (BG) control that the
AP has to offer.

Inclusion Criteria:

- Clinical diagnosis of type 1 diabetes,

- The diagnosis of type 1 diabetes is based on the investigator's judgment

- C peptide levels and antibody determinations are not required

- Daily insulin therapy for ≥ 12 months

- Insulin pump therapy for ≥ 3 months

- Age ≥5 - ≤8 years old

- Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the
continuous glucose monitor.

- Willingness to wear a continuous glucose sensor and physiological monitor for the
duration of the study

Exclusion Criteria:

The presence of any of the following is an exclusion for the study:

- Diabetic ketoacidosis in the past month

- Hypoglycemic seizure or loss of consciousness in the past 3 months

- History of seizure disorder (except for hypoglycemic seizure)

- History of any heart disease including coronary artery disease, heart failure, or
arrhythmias

- Cystic fibrosis

- Current use of oral glucocorticoids, beta-blockers or other medications, which in the
judgment of the investigator would be a contraindication to participation in the
study.

- History of ongoing renal disease (other than microalbuminuria).

- Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or
Glargine).

- Subjects requiring other anti-diabetic medications other than insulin (oral or
injectable).

- Presence of a febrile illness within 24 hours of admission or acetaminophen use while
wearing the CGM. The subject may be rescheduled for Research House/Hotel Admission if
these criteria are not met. The study subject will not participate in the trial if
these conditions are met.

- Medical or psychiatric condition that in the judgment of the investigator might
interfere with the completion of the protocol such as:

- Inpatient psychiatric treatment in the past 6 months

- Uncontrolled adrenal insufficiency