"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)

Inclusion Criteria

• Participant is 18 - 70 years of age inclusive
• Participant is in generally good health, as determined by the investigator
• Participant is willing and able to individually complete written informed consent and agrees to comply with all study related testing and examinations
• 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
• Participant has been diagnosed with T1DM for at least 12 months
• C-peptide less than 0.6 nmol per L at screening
• Subject can provide a minimum of 14 days of insulin pump data to demonstrate pump use compliance
• 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
• Participant has BMI in the range 20 - 35 kg per square metre inclusive
• Participant has experience infusing a rapid-acting insulin analog for at least 6 months
• Participant has been using an insulin pump with commercially available infusion sets for at least 6 months (this includes Automated Insulin Delivery systems)
• 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
• Participant has ability to understand and comply with protocol procedures and to provide informed consent
• AST and ALT less than or equal to 120 U per L
• Creatinine less than 1.8 mg per dL

Exclusion Criteria

• 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)
• Participants who routinely change their commercial insulin infusion sets twice weekly or less often (wear time greater than 3.5 days)
• 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.)
• Participant has abnormal skin at intended device infusion sites (existing infection, inflammation, burns, or other extensive scarring)
• Participant has HbA1C greater than 8.5 percent at screening
• 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.
• Participant has a history of diabetic ketoacidosis in the last 6 months
• Participant has known cardiovascular disease considered to be clinically relevant by the investigator
• Participant has known arrhythmias considered to be clinically relevant by the investigator
• Participant has known history of:
• Cushing's Disease,
• pancreatic islet cell tumor, or
• insulinoma
• Participant has:
• Lipodystrophy,
• extensive lipohypertrophy, as assessed by the investigator
• Participant is undergoing current treatment with:
• Systemic oral or intravenous corticosteroids,
• monoamine oxidase (MAO) inhibitors,
• non-selective beta-blockers,
• growth hormone,
• thyroid hormones, unless use has been stable during the past 3 months
• 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:
• Alcoholism,
• drug abuse
• Significant acute or chronic illness, that in the investigator's opinion, might interfere with subject safety or integrity of study results
• Planned operation, MRI or CT which require removal of infusion set or CGM sensor during wear periods
• Current participation in another clinical drug or device study
• AST and ALT greater than 120 U per L
• Creatinine equal to or greater than 1.8 mg per dL -