FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump

Inclusion Criteria

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
• Male or female, age ≥18 years at the time of signing informed consent
• Documented diagnoses of T1DM ≥1 year prior to the day of screening
• Using the Medtronic pump Minimed 670G for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least 30 days prior to screening and willing to continue using their personal Medtronic Minimed 670G and CSII for insulin treatment throughout the trial.
• Ability and willingness to use the same insulin infusion sets throughout the trial
• Using the same insulin for at least 30 days prior to screening
• HbA1c < 8.5% as assessed by local laboratory at screening
• BMI ≤ 35.0 kg/m2 at screening
• Ability and willingness to adhere to the protocol including performing SMPG profiles, attending visits, utilizing the auto mode feature of the pump for at least 80 % of the time during the study, and completing meal tests

Exclusion Criteria

• Known or suspected hypersensitivity to trial products or related products
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
• Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies
• Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial
• Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the past 180 days prior to the day of screening
• Subjects classified as being in New York Heart Association (NYHA) Class IV at screening
• Planned coronary, carotid or peripheral artery revascularization known on the day of screening.
• Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic

≥180 mmHg or diastolic ≥110 mmHg) at screening

• Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening
• Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 45 ml/min/1.73 m2
• Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism in the opinion of the Investigator
• Proliferative retinopathy or maculopathy requiring acute treatment at the time of screening
• History of hospitalization for ketoacidosis ≤180 days prior to the day of screening
• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 30 days before screening
• Presence of malignant neoplasms at the time of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
• Reoccurring Severe hypoglycemia while on the Medtronic Minimed 670G in the investigators opinion
• Any condition which, in the opinion of the Investigator, might jeopardize Subject's safety or compliance with the protocol

-