Testing the Effect of the InsuPad Device in Daily Life Conditions

Exclusion Criteria

• •Excessive fibrosis, lipo-hypertrophy or eczema at injection sites.
• •Known gastro- or enteroparesis.
• •Unstable chronic disease other than diabetes mellitus (e. g. unstable angina pectoris, renal disease) for the last six months before study start.
• •Severe hypoglycaemic events requiring glucagon injection or glucose infusion within the last four weeks prior to study start.
• •Hypoglycaemia unawareness (Score \> 4 in the Hypoglycaemia Awareness Questionnaire)
• •Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study start
• •Any known life-threatening disease
• •Pregnant women, lactating women or women who intend to become pregnant during the observation period
• •Any other condition or compliance issues that might interfere with study participation or results
• •Subjects with heat sensitivity
• •Subjects involved in or planned to participate in other studies
• •Subjects who are incapable of contracting or under guardianship