Model Predictive Control (MPC) Artificial Pancreas vs. Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) With Different Food Choices in the Outpatient Setting

The goal of this study is to compare the efficacy and safety of an AID system using a MPC
algorithm versus SAP/PLGS therapy with different food choices over a 4 week period.

The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose
monitoring sensor, and a smart phone that contains the algorithm and communicates with the
other devices.

In this study, during each two-week period, subjects will be given pre-weighed portions of
different meals to eat (either regular semolina pasta or extra-long grain white rice) with
detailed cooking instructions, and will eat these meals on 6 different occasions for dinner.
They will bolus as they normally do for these meals. This will allow us to observe the
postprandial meal response when using sensor-augmented pump (SAP) or iAPS, showing the
importance of nutrition choices with modern technological treatments in T1D.

Inclusion Criteria:

- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least
one year and using insulin for at least 1 year.

- Using an insulin pump for at least 3 months at the time of screening. Insulin pump use
includes use of automated features, to include predictive or threshold low-glucose
suspend or hybrid closed-loop with without a Dexcom sensor.

- Familiarity and use of a carbohydrate ratio for meal boluses.

- Age ≥18.0 years old

- HbA1c < 10.5%, as performed by point of care or central laboratory testing. A1c will
be assessed at the screening visit, or if already completed within 2 weeks of the
screening visit, the prior lab value may be used in lieu of repeating this assessment.

- For females, not currently known to be pregnant. If female and sexually active, must
agree to use a form of contraception to prevent pregnancy while a participant in the
study. A negative serum or urine pregnancy test will be required for all females of
child-bearing potential. Participants who become pregnant will be discontinued from
the study. Also, participants who during the study develop and express the intention
to become pregnant within the timespan of the study will be discontinued.

- Willingness to switch home pump to PLGS or full manual mode if using hybrid
closed-loop with an FDA approved system.

- Have an emergency contact living at home with the subject who will be available to be
contacted by the study staff overnight in the event of an emergency.

- Investigator has confidence that the participant can successfully operate all study
devices and is capable of adhering to the protocol, to include having basic cooking
equipment at home to prepare the study meals.

- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already,
and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the
study.

- Willingness not to start any new non-insulin glucose-lowering agent during the course
of the trial.

Exclusion Criteria:

- Use of an unapproved closed-loop insulin delivery system within 2 weeks before
screening or during the study is not allowed.

- Gastrointestinal disease such as celiac disease or multiple food allergies.

- Any form of gluten sensitivity or wheat allergy.

- Allergies to any form of nuts or ingredients present in the study meals (tomatoes
etc).

- History of difficulty digesting food.

- Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than
metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors,
sulfonylureas).

- Hemophilia or any other bleeding disorder

- 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.

- Self-reported or clinically documented hypoglycemia unawareness.

- A condition, which in the opinion of the investigator or designee, would put the
participant or study at risk

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

- Having a direct supervisor at place of employment who is also directly involved in
conducting the clinical trial (as a study investigator, coordinator, etc.); or having
a first-degree relative who is directly involved in conducting the clinical trial