Clinical trial NCT00211510: Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Diabetes
Continuous Glucose Monitoring
Glycemic Control
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 146
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in A1c From Baseline to 26 Weeks
timeFrame: Baseline and 26 weeks
Secondary outcomes:
measure: Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26
timeFrame: Baseline and 26 weeks
measure: Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26
timeFrame: Baseline and 26 weeks
measure: Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26
timeFrame: Baseline and 26 weeks
measure: Glucose Sensor Accuracy as Measured in the 722 Group
timeFrame: Baseline and 26 weeks
measure: Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups
timeFrame: Baseline and 26 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Albany
country: United States
facility: The Endocrine Group
state: New York
city: San Antonio
country: United States
facility: Diabetes and Glandular Diabetes Research Associates
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Medtronic
name: Scott W Lee, MD
role: STUDY_DIRECTOR
References: