Fuzzy Logic Automated Insulin Regulation

Seven clinical sites (4 in the US and 3 in Europe) will enroll patients with type 1 diabetes
(T1D), ages 14 to less than 30 years old, who have an HbA1c from 7-12% and are using multiple
daily injections of insulin (with or without continuous glucose monitoring -CGM) or are using
and insulin pump (with or without CGM). Participants may not be currently using the Medtronic
670G system. All patients will be assessed for their QOL and attitudes about the use diabetes
management technology.

- Patients glucose control on their current insulin treatment regimen will be assessed for
2 weeks using blinded CGM (CGM they cannot see the glucose reading on).

- Then all participants will be started on the same insulin pump (Medtronic 670G) and the
pump standard insulin delivery settings will be adjusted.

- Next all participants will start an Enlite 3 continuous glucose sensor and be instructed
on its use and further adjustments to the insulin pump settings will be made using this
CGM information. The pump remains in the usual manual mode or open loop mode of
operation at this time.

- All patients will then be randomized to start hybrid closed loop therapy using one of
two systems for 12 weeks. They will either use the 670G pump (which uses an algorithm
called PID to adjust insulin delivery based on the Enlite 3 CGM data) in open loop or
auto mode for 3 months or they will use a different Medtronic Pump very similar in
nature the 670G but this has a slightly different algorithm called PID + Fuzzy Logic) to
adjust insulin delivery based on the Enlite 3 CGM data in open loop or auto mode for 3
months. Glucose control, adjustment to the technology and the safety of the technology
will all be carefully evaluated over this 3 month period with the participants at home,
school or work undergoing their usual activities. They will have regular contact with
the study team and will intermittently share their ongoing CGM glucose data with the
study team at a clinic visit or by uploading their glucose and insulin data to the cloud
so it can viewed in a secure fashion by the study team.

- At the end of 3 months each participant will go back on the 670 G and the CGM system in
manual mode or open loop for one month. This is called the washout period.

- Then all participants will switch to or crossover to the hybrid closed system they were
not on originally and use this new hybrid closed loop system in closed loop or auto mode
for 3 months as above.

- At the end of each 3 month period on either the 670G system using the PID algorithm or
the new hybrid closed loop system using the PID + Fuzzy Logic algorithm participants
will rate their QOL and their adjustment to and attitude toward the hybrid closed loop
system they are using.

- A careful analysis of the all measures of glucose control based on the CGM data for each
3 month period for each hybrid closed loop system will be collected and compared. In
addition system safety data will be collected as will all medical events during the
study.

After each participant has completed 3 months on each hybrid closed loop system the
investigators will be able to compare the effectiveness, safety and patient preference
regarding each system.

Inclusion Criteria:

1. Type 1 diabetes mellitus with duration of at least one year.

2. Multiple daily injections of insulin or an insulin pump user

3. HbA1c 7.0%-12.0%

4. Willingness or ability to do carbohydrate counting

5. In the investigator's judgment, able to understand and likely to be adherent to the
protocol

6. For subjects <18 years old, living with one or more parent/legal guardian 7. Have
internet access and a computer system that meets requirements for uploading data

Exclusion Criteria:

1. Concomitant disease that influence metabolic control (e.g. anemia, significantly
impaired hepatic function, renal failure, history of adrenal insufficiency)

2. Other medical condition which, in the Investigator's opinion, may compromise patient
safety, affect outcome assessments, or affect the subject's ability to follow the
protocol.

3. Oral or parenteral glucocorticoids taken within 1 month prior to enrollment, or plans
to take oral or parenteral glucocorticoids within the planned study duration.

4. Use of antidiabetic agents other than insulin

5. Use of other medications, which in the judgment of the investigator would be a
contraindication to participation in the study

6. Known allergy to medical grade adhesives

7. Participation in another study of a medical device or drug that could affect glucose
measurements or glucose management or receipt of any investigational medical product
within 1 month prior to enrollment

8. Female subject of child-bearing potential who has a positive pregnancy test at
screening, is pregnant, breast-feeding, or planning to become pregnant within the
planned study duration (or is not using adequate contraceptive methods)

9. Current eating disorder such as anorexia or bulimia

10. One or more episodes of ketoacidosis requiring hospitalization within 6 months prior
to screening

11. Clinically significant nephropathy (eGFR <30 ml/min) or receiving dialysis

12. Untreated thyroid disease

13. Working a night shift