FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Fiasp®; Novolog®; 670G hybrid closed loop continuous subcutaneous insulin infusion system
Intervention description: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system; Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system; CSII
Intervention MeSH terms: Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an exploratory, single-center, randomized, open label, active-controlled, complete
      cross-over trial comparing safety and efficacy of Fiasp® versus NovoLog® when used in the
      Medtronic MiniMed 670G system in subjects with T1DM.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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

          2. Male or female, age ≥18 years at the time of signing informed consent

          3. Documented diagnoses of T1DM ≥1 year prior to the day of screening

          4. 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.

          5. Ability and willingness to use the same insulin infusion sets throughout the trial

          6. Using the same insulin for at least 30 days prior to screening

          7. HbA1c < 8.5% as assessed by local laboratory at screening

          8. BMI ≤ 35.0 kg/m2 at screening

          9. 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:

          1. Known or suspected hypersensitivity to trial products or related products

          2. 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)

          3. Participation in another clinical trial within 28 days before the screening visit.
             Note: clinical trials do not include non-interventional studies

          4. Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping
             pattern) throughout the trial

          5. 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

          6. Subjects classified as being in New York Heart Association (NYHA) Class IV at
             screening

          7. Planned coronary, carotid or peripheral artery revascularization known on the day of
             screening.

          8. Inadequately treated blood pressure defined as Grade 3 hypertension or higher
             (Systolic

             ≥180 mmHg or diastolic ≥110 mmHg) at screening

          9. Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening

         10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 45
             ml/min/1.73 m2

         11. 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

         12. Proliferative retinopathy or maculopathy requiring acute treatment at the time of
             screening

         13. History of hospitalization for ketoacidosis ≤180 days prior to the day of screening

         14. Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria within 30 days before screening

         15. Presence of malignant neoplasms at the time of screening. Basal and squamous cell skin
             cancer and any carcinoma in-situ is allowed.

         16. Reoccurring Severe hypoglycemia while on the Medtronic Minimed 670G in the
             investigators opinion

         17. Any condition which, in the opinion of the Investigator, might jeopardize Subject's
             safety or compliance with the protocol

             -