"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)
"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)
Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using
 continuous subcutaneous insulin infusion with an infusion set that needs to be changed every
 3 days. This study will assess the feasibility and device performance of the study device,
 the Achilles infusion set over three periods during routine insulin infusion.

 This study will include 20 participants and has 3 periods:

 Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7
 days): participants will manage their blood glucose solely with their insulin pump and the
 Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose
 monitoring (CGM) device.

 Period 3 (up to 7 days): Participants will return to study centre to receive a fresh Achilles
 infusion set and continue blood glucose management at home until infusion set failure or 7
 days.
This is a prospective, non-randomized, home-use feasibility study of device performance,
 usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles
 infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in
 up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).

 The CapBio Achilles infusion set is a sterile single use device designed to be used with
 commercially available infusion pumps (e.g., Medtronic MiniMed). The investigational Achilles
 infusion set contains a coil reinforced soft polymer indwelling cannula with one distal and
 three proximal holes.

 The primary objective of this study is to determine feasibility and device performance of the
 CapBio Achilles infusion set over 2 extended home use wear periods of up to 7 days each
 during routine therapeutic insulin infusion. Feasibility is evidenced by the absence of
 uncontrolled hyperglycemia and/or suspected infusion set cannula occlusion.
Inclusion Criteria:

 1. Participant is 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 less than 0.6 nmol per L at screening

 7. Subject can provide a minimum of 14 days of insulin pump data to demonstrate pump use
 compliance

 8. Participant is willing to perform serum ketone measurements whenever the blood glucose
 is determined to be greater than 250 mg per dL (14 mmol per L) using a ketone meter
 and strips provided by the sponsor

 9. Participant has BMI in the range 20 - 35 kg per square metre inclusive

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

 11. Participant has been using an insulin pump with commercially available infusion sets
 for at least 6 months (this includes Automated Insulin Delivery systems)

 12. Participant has previous experience using a continuous glucose monitor (CGM) and is
 willing to use a CGM for the duration of the study and perform necessary calibration
 fingerstick glucose readings

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

 14. AST and ALT less than or equal to 120 U per L

 15. Creatinine less than 1.8 mg per dL

 Exclusion Criteria:

 1. Participants whose average total daily insulin dose exceeds 85 units per day (i.e.
 typically change insulin reservoirs more often than every 3.5 days on average)

 2. Participants who routinely change their commercial insulin infusion sets twice weekly
 or less often (wear time greater than 3.5 days)

 3. Female participant is pregnant or nursing (Documented negative pregnancy test results
 for female participants required unless participant is menopausal without any
 spontaneous menstrual cycles for >12 months or key organs have been removed.)

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

 5. Participant has HbA1C greater than 8.5 percent 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 beta-blockers,

 4. growth hormone,

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

 13. Subject has significant history of any of the following, that in the opinion of the
 investigator would compromise the subject'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 subject 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 participation in another clinical drug or device study

 17. AST and ALT greater than 120 U per L

 18. Creatinine equal to or greater than 1.8 mg per dL -