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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-02-28

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.

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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).

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paradigm 722 sensor augmented pump

subjects will use the Paradigm 722 sensor augmented pump for infusion of insulin and continuous glucose monitoring

Group Type EXPERIMENTAL

Paradigm 722 sensor augmented pump

Intervention Type DEVICE

Subjects use the Paradigm 722 sensor augmented pump

Paradigm 715 insulin pump

subjects will use the Paradigm 715 insulin pump which does not include sensor augmentation for infusion of insulin

Group Type ACTIVE_COMPARATOR

Paradigm 715 insulin pump

Intervention Type DEVICE

Subjects use the Paradigm 715 insulin pump

Interventions

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Paradigm 722 sensor augmented pump

Subjects use the Paradigm 722 sensor augmented pump

Intervention Type DEVICE

Paradigm 715 insulin pump

Subjects use the Paradigm 715 insulin pump

Intervention Type DEVICE

Other Intervention Names

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722 pump 715 pump

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