Type 1 Diabetes Clinical Trial
Official title:
Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes: A Multi-center, Randomized Controlled Trial
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).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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