Evaluation of Accu-Chek DiaPort, a Port System for Continuous Intraperitoneal Insulin Infusion, in Patients With Type I Diabetes

Inclusion Criteria

• •Adult patients, \>= 18 years of age at the time of the screening visit
• •Type 1 diabetes mellitus
• •On CSII therapy for at least 6 months prior to the screening visit
• •Has been unsuccessfully treated with standard subcutaneous insulin therapy including CSII therapy, as defined by frequent (defined as handicapping in daily life) or severe (needing help from a third party) hypoglycemia and/or HbA1c above 8.5%, and/or other medical indication for CIPII therapy
• •Presence of at least one of the following indications for CIPII therapy: - Frequent (defined as handicapping daily life) hypoglycemia during CSII therapy - Severe hypoglycemia (needing help from a third party) during CSII therapy - HbA1c above 8.5% during CSII therapy - Hypoglycemia unawareness during CSII therapy - Real subcutaneous insulin resistance - Insulin-induced lipoatrophy - Insulin-associated lipohypertrophy not controlled by site rotation - Other skin disorders interfering with the subcutaneous route of administration - Marked fluctuations of glucose levels and insulin requirements during CSII therapy- History of allergies to materials required for subcutaneous insulin therapy
• •Performs usually self-management of blood glucose at least 4 times per day
• •Willing to adhere to the study visit schedule and motivated to undergo the therapy