Safety and Feasibility Evaluation of the APS APP
Safety and Feasibility Evaluation of the APS APP
This clinical trial is a safety and feasibility study to assess the performance of artificial
 pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring
 System (HMS) algorithms embedded into the APS APP platform.
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.