The Guardcontrol Trial: Study to Assess if Type 1 Diabetics Can Improve Using the Real-time Values of Guardian RT

Inclusion Criteria

• •Patient has signed Informed consent form prior to Study Entry.
• •Patients have been diagnosed with type 1 diabetes mellitus (DM) at least 12 months prior to Study Entry.
• •HbA1c must be 8.1% or above at study entry day (central lab value).
• •Patients must perform at least two self-monitoring blood glucose finger-sticks daily.
• •Patients are on intensive insulin therapy; for multiple daily injections (MDI) patients specifically, be on a schedule of a minimum of 3 injections daily.
• •Patients on intensive insulin therapy must be on continuous subcutaneous insulin infusion (CSII) or MDI at least 3 months prior to inclusion and should have been receiving diabetes care from the investigator of each centre for the 6 months prior to inclusion.
• •Patients must be using only insulin analogues or rapid-acting human insulin for their meal boluses.
• •Patients are willing to undergo all study procedures.
• •Patients are trained on how to adapt their insulin dose to their meals and are knowledgeable concerning how to calculate and apply corrective insulin boluses post-prandially, as well as on the influence of physical activity and other life style factors on their glycemia.
• •Patients are willing to participate in a Guardian® RT product training course
• •Patients understand how to adjust and administer corrective treatment.