User Evaluation of the MiniMed 640G Insulin Pump

You may be eligible if

• Criteria for Inclusion: A subject is eligible for the user evaluation study if all of the following criteria are met:
• 1. Subject is 7 years or older at time of screening
• 2. Subject is current insulin pump user for at least 3 months
• 3. Subject has the following CGM experience as determined by the Investigator:
• * Has experience and is able to insert/change sensor by herself/himself and
• * Has experience and can recharge the transmitter and
• * Has experience and can read sensor data in real-time on her/his pump screen
• 4. Subject/legal representative has signed a Patient Informed Consent and is willing to comply with the study procedures;
• 5. Subject is willing to complete study questionnaires throughout the study
• 6. Must have the following clinical diagnosis:
• 1\. Type 1 diabetes, for a minimum of 6 months prior to enrollment
• Criteria for Exclusion: A subject is excluded from the user evaluation if any of the following criteria are met:
• 1. Female subject has a positive urine pregnancy screening test.
• 2. Female subject who plans to become pregnant during the course of study. If a woman becomes pregnant during participation, she will be withdrawn
• 3. Subject has any condition that, in the opinion of the Investigator or qualified Investigational Centre staff, may preclude him/her from participating in the study and completing study related procedures.
• 4. Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Centre staff
• 5. Subject is unable to tolerate tape adhesive in the area of sensor placement
• 6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection)
• 7. Subject has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled