The InsuPad in Daily Life Study - Effect of Local Heating on Postprandial Glucose Excursions Using the InsuPad Device

Inclusion Criteria:

• Male or female patients aged 18 to 70 years (values included)
• Type 1 diabetes mellitus or insulin treated type 2 diabetes with daily insulin demand ≥ 0.7 units per kg bodyweight.
• 6% ≤ HbA1c ≤ 9.5%
• Use of short-acting prandial insulin analogues with injections
• Study subject is willing to perform at least 5 blood glucose measurements per day for at least 56 days, willing to comply with study procedures and to keep a detailed patient log book.
• Willing to sign informed consent

Exclusion Criteria:

• Excessive fibrosis, lipo-hypertrophy or eczema at injection sites.
• Known gastro- or enteroparesis.
• Unstable chronic disease other than type 1 diabetes (e.g. Unstable angina factoris, , renal disease) for the last six months before study start.
• Severe hypoglycemic 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, see appendix)
• 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 planed to participate in other studies
• Subjects who are incapable of contracting or under guardianship