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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Paradigm 722 sensor augmented pump
* Device: Paradigm 715 insulin pump


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paradigm 722 sensor augmented pump<br>subjects will use the Paradigm 722 sensor augmented pump for infusion of insulin and continuous glucose monitoring | Device: Paradigm 722 sensor augmented pump<br>* Subjects use the Paradigm 722 sensor augmented pump<br>* Other names: 722 pump;|
| Active Comparator: Paradigm 715 insulin pump<br>subjects will use the Paradigm 715 insulin pump which does not include sensor augmentation for infusion of insulin | Device: Paradigm 715 insulin pump<br>* Subjects use the Paradigm 715 insulin pump<br>* Other names: 715 pump;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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). | Baseline and 26 weeks | 
| Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups | 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. | Baseline and 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Continuous Glucose Monitoring, Glycemic Control