PK/PD of an Extended Wear Infusion Set for CSII in T1DM Patients ("PEXIS")
PK/PD of an Extended Wear Infusion Set for CSII in T1DM Patients ("PEXIS")
This study has been designed as a prospectively enrolled, randomized sequence, 2-way
 crossover study of device performance, tolerability and safety of an investigational insulin
 infusion set using a coil-reinforced soft polymer indwelling cannula versus a commercial
 insulin infusion set using a soft Teflon indwelling cannula, during two 7-day home use
 periods with 4 in-clinic euglycemic clamp sessions during each of the 7-day periods. After a
 wash-out period, subjects will cross over into the investigational or control group,
 respectively.
Inclusion Criteria:

 In order to be eligible to participate in this study, an individual must meet all of the
 following criteria:

 1. Participants are 18 - 70 years of age inclusive

 2. Participant is in generally good health, as determined by the investigator

 3. Participant is willing and able to individually complete written informed consent and
 agrees to comply with all study related testing and examinations

 4. Participant must be geographically stable (e.g., expects to be available and capable
 of returning for all study specified test and examinations) during the study period

 5. Participant has been diagnosed with T1DM for at least 12 months

 6. C-peptide <0.6 nmol/L at screening

 7. Participant has been using insulin pump therapy for at least 6 months and is currently
 using a Medtronic MiniMed pump, model series 530 or higher. Use of 670G in auto mode
 is acceptable.

 8. Participant can provide a minimum of 14 days of insulin pump data to demonstrate pump
 use compliance

 9. Participant is willing to perform frequent (4 times per day or more) self-monitoring
 of blood glucose (SMBG), including before meals and before bed, and using a meter and
 test strips provided by the sponsor during the two weeks of active treatment. This
 includes participants who are currently using real-time continuous glucose monitoring
 and may continue to do so, but must also collect SMBG values as instructed.

 10. Participant is willing to perform serum ketone measurements whenever the blood glucose
 is determined to be greater than 250 mg/dL after extended fasting (e.g. overnight or
 more than five hours after a meal) using a ketone meter and strips provided by the
 sponsor

 11. Participant has BMI in the range 20 - 35 kg/m2 inclusive

 12. Participant has experience infusing a rapid-acting insulin analog for at least 6
 months

 13. Participant has been using or is willing to use CGM (reading data available for at
 least 80% of time for a week of data collection during the screening period).
 Participants already using - Dexcom G6 real time CGM may continue to use their own CGM
 unit; participants not using the G6 will be provided with a G6 monitor. All
 participants will be provided with CGM disposables for use during the treatment
 period.

 14. Participant has ability to understand and comply with protocol procedures and to
 provide informed consent

 15. HbA1c ≤8.5%

 16. Stable body weight in the 3 months prior to enrollment (change in body weight <5%)

 Exclusion Criteria:

 An individual who meets any of the following criteria will be excluded from participation
 in this study:

 1. Participants whose average total daily insulin dose exceeds 85 units/day (i.e.
 typically change insulin reservoirs more often than every 4 days on average)

 2. Participants who routinely change their commercial insulin infusion sets on average
 less often than every 4.5 days

 3. Female participant is pregnant or nursing

 4. Participant has abnormal skin at intended device infusion sites (existing infection,
 inflammation, burns, or other extensive scarring)

 5. Participant has hemoglobin <12.0 g/dL or potassium < 3.5 mEq/L at screening

 6. Participant has documented history in last 6 months of severe hypoglycemia associated
 with cognitive dysfunction sufficiently severe to require third party intervention or
 a history of impaired awareness of hypoglycemia.

 7. Participant has a history of diabetic ketoacidosis in the last 6 months

 8. Participant has known cardiovascular disease considered to be clinically relevant by
 the investigator

 9. Participant has known arrhythmias considered to be clinically relevant by the
 investigator

 10. Participant has known history of:

 1. Cushing's Disease,

 2. pancreatic islet cell tumor, or

 3. insulinoma

 11. Participant has:

 1. Lipodystrophy,

 2. extensive lipohypertrophy, as assessed by the investigator

 12. Participant is undergoing current treatment with:

 1. Systemic oral or intravenous corticosteroids,

 2. monoamine oxidase (MAO) inhibitors,

 3. non-selective systemic beta-blockers,

 4. growth hormone,

 5. thyroid hormones, unless use has been stable during the past 3 months

 6. SGLT2 inhibitors

 13. Participant has significant history of any of the following, that in the opinion of
 the investigator would compromise the participant's safety or successful study
 participation:

 1. Alcoholism,

 2. drug abuse

 14. Significant acute or chronic illness, that in the investigator's opinion, might
 interfere with participant safety or integrity of study results

 15. Planned operation, MRI or CT which require removal of infusion set or CGM sensor
 during wear periods

 16. Current treatment with systemic (oral or IV) corticosteroids, monoamine oxidase (MAO)
 inhibitors, non-selective beta-blockers, growth hormone, herbal products that, in the
 opinion of the investigator, may alter insulin sensitivity or confer undue risk to the
 participant's participation in the study or non-routine vitamins. Furthermore, thyroid
 hormones are not allowed unless the use of these has been stable during the past 3
 months.

 17. Current participation in another clinical drug or device study

 18. Inability of the participant to comply with all study procedures or to understand the
 participant instructions