Testing the Effect of the InsuPad Device in Daily Life Conditions

This is an interventional treatment trial for Diabetics Mellitus Type 1 focused on measuring DM, insulin, injections Read More

Inclusion Criteria:

• Male or female subjects aged 18 to 75 years (including 18 and 75 years old).
• Type 1 or type 2 diabetes mellitus subjects with daily short-acting prandial insulin intake of > 60 IU/day.
• HbA1c >=6.0% and =< 8%
• Use of short-acting prandial insulin analogues with multiple daily injections. The analog insulin brands to be used will be either insulin Lispro (Humalog, Liprolog) or insulin Aspart (NovoRapid) or insulin Glulisin (Apidra).
• Subject agrees to sign consent form before any study-specific tests or procedures are to be performed.
• Study subject is willing to perform at least 5 blood glucose measurements per day for at least 3 months, willing to comply with study procedures and to keep a detailed patient log book.

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