Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes
Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes
The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm
 722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control
 when compared to subjects using the Paradigm 715 insulin pump only.
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).
Inclusion Criteria:

 -  Age 12 - 80 years

 -  Type 1 Diabetes Mellitus diagnosed at least 1 year ago

 -  Using insulin infusion pump for past 6 months minimum

 -  Performing minimum 4 blood glucose tests per day

 -  Agree to treat to A1c targets

 -  Read and understand English

 Exclusion Criteria:

 -  Pregnant or planning pregnancy

 -  History of unresolved tape allergy or skin conditions