InsuLearn Feasibility With Type 1 Diabetes Patients Under MDI Therapy

Exclusion Criteria

• •1. NPH (neutral protamine hagedorn) insulin
• •2. Use of any medication that at the discretion of the investigator is deemed to interfere with the trial.
• •3. Currently being treated for a seizure disorder.
• •4. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol, such as but not limited to, the following examples:
• •1. Inpatient psychiatric treatment in the past 6 months
• •2. Presence of a known adrenal disorder
• •3. Abnormal liver function test results (Transaminase \>3 times the upper limit of normal)
• •4. Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2).
• •5. Active gastroparesis requiring medical therapy.
• •6. Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L).
• •7. Abuse of alcohol or recreational drugs
• •8. Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection).
• •9. Uncontrolled arterial hypertension (Resting diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>180 mmHg).
• •10. Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy or VEGF inhibitor injections) in the past 12 months.
• •5. Currently pregnant or intent to become pregnant during the trial.
• •6. Currently breastfeeding.
• •7. An injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication, or disease in the judgment of the investigator will affect the completion of the protocol.
• •8. Participation in another pharmaceutical or device trial at the time of enrolment or during the study.
• •9. Non-stable dose of non-insulin glucose-lowering agent during the trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, sulfonylureas and naturaceuticals) as defined by study physician.