Safety and Feasibility Evaluation of the APS APP

The system will be evaluated on up to 10 adult subjects with type 1 diabetes age 18-75 years
old at a single clinical site (Sansum Diabetes Research Institute), who will complete a
48-hour closed-loop (CL) session in an observed CRC environment with medical staff present.
During the session subjects will bolus for all meals and snacks and perform a 45-minute
walking session while supervised by medical staff. The AP system used consists of an insulin
pump, a CGM sensor, and a phone app (the Artificial Pancreas System [APS] phone app).

Inclusion Criteria:

- Age ≥ 18 and ≤ 75 years at the time of screening.

- Clinical diagnosis of type 1 diabetes for at least one year.

- Has been using an insulin pump for at least 6 months at the time of screening.

- HbA1c < 10.5%.

- Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.

- Willing to perform at least 7 fingerstick blood glucose tests a day.

- If using Apidra (insulin glulisine) at home and planning to use the Tandem t:AP pump
for the closed-loop session, willing to switch to Novolog or Humalog for the
closed-loop session.

- Willing to refrain from taking acetaminophen products for the duration of the clinical
trial.

- Willing to abide by the study protocol and use study-provided devices, including the
Omnipod OR Tandem Pump, Dexcom CGM, glucometer, ketone meter and APS APP on the study
phone device.

Exclusion Criteria:

- Pregnancy

- One or more episodes of hypoglycemia requiring an emergency room visit or
hospitalization in the past 6 months.

- One or more episodes of hyperglycemia requiring an emergency room visit or
hospitalization in the past 6 months.

- Known unstable cardiac disease or untreated cardiac disease, as revealed by history or
physical examination.

- Dermatological conditions that would preclude wearing a CGM sensor or Pod/infusion
site.

- One or more seizures in the past year.

- Any condition that could interfere with participating in the trial, based on
investigator judgment.

- Participation in another pharmaceutical or device trial at the time of enrollment or
during the study.