Evaluation of the Safety Use of the InsuPatch Device in Daily Life Conditions

Exclusion Criteria

• •1. Pregnancy
• •2. Breast feeding women.
• •3. Alcohol addiction
• •4. CABG (Coronary Artery Bypass Graft), MI (Myocardial Infarction) or active Ischemic Heart Disease prior to study date.
• •5. CVA (cardiovascular accident) or TIA (transient ischemic accident) events prior to study date.
• •6. Uncontrolled hypertension (blood pressure in mm HG \>160 systolic or \> 95 diastolic) .
• •7. Any history of gastroparesis or enteroparesis.
• •8. Abnormal kidney and/ or liver function tests. (Defined as Creatinine \>1.5 mg/dL, liver tests\> 2 times the upper limit of normal).
• •9. A severe hypoglycemic event requiring a glucagon injection or intravenous glucose infusion within the last six months prior to study inclusion.
• •10. Hypoglycemia unawareness.
• •11. Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study inclusion.
• •12. Psychological incompetence.
• •13. Signs of drug abuse.
• •14. Any other clinical condition or history, which seems to be relevant for the Principle Investigator to disqualify a participant.
• •15. Subjects with diminished skin integrity, Excessive fibrosis, lipo-hypertrophy or eczema at infusion sites.
• •16. Heat sensitive subjects.
• •17. Subjects involved in or planning to participate in other studies.
• •18. Subjects using any drug therapy, other than insulin, to control their blood glucose levels.