Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes (STAR1)

• Change in A1c From Baseline to 26 Weeks [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
  Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.
  
  

• Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: Yes ]
  Severe Hypoglycemia as defined by hypoglycemic events requiring the assistance of another person to actively administer carbohydrates, glucagon or other resuscitative actions, as reported by subject. The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 26.
  
  
• Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
  Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 26
  
  
• Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26 [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
  Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 26
  
  
• Glucose Sensor Accuracy as Measured in the 722 Group [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
  Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B).
  
  
• Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
  Questionnaire evaluating subjects'potential fear of hypoglycemia events. Change assessed at Baseline and Week 26 and compared between groups. Likert scale scored with 4 being the worst and 0 being no problem.
  
  

Glycemic control remains a significant challenge for both adult and adolescent Type 1 diabetics. Continuous Glucose Monitoring (CGMS) is currently used by clinicians to record continuous, retrospective glucose measurements which aid in identification of glycemic excursion patterns. This data is then used to make therapy change recommendations for the future. The Paradigm 722 System transmits real-time glucose measurements to the insulin pump every 5 minutes, allowing users to view their current glucose values, as well as to review glycemic excursions and trends over a 24-hour period. This System will alert users to high and low glucose levels, and will allow subjects and their clinicians to treat to a therapeutic target HbA1c under monitored conditions.

Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm 715 Insulin Pump over a 6 month period to evaluate changes in glycemic control (HbA1c).