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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
Subjects use the Paradigm 722 sensor augmented pump
Subjects use the Paradigm 715 insulin pump
Children's Hospital of Los Angeles
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Change in A1c From Baseline to 26 Weeks
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.
Time frame: Baseline and 26 weeks
Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26
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.
Time frame: Baseline and 26 weeks
Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26
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
Time frame: Baseline and 26 weeks
Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26
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
Time frame: Baseline and 26 weeks
Glucose Sensor Accuracy as Measured in the 722 Group
Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B).
Time frame: Baseline and 26 weeks
Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups
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The Endocrine Group
Albany, New York, United States
Diabetes and Glandular Diabetes Research Associates
San Antonio, Texas, United States
University of Washington
Seattle, Washington, United States
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.
Time frame: Baseline and 26 weeks