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Sponsored by: |
Medtronic Diabetes |
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Information provided by: | Medtronic Diabetes |
ClinicalTrials.gov Identifier: | NCT00417989 |
Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (MDI) Group".
Secondary Outcomes: Incidence and frequency of severe hypoglycemia; Measure of glycemic variability, AUC; Quality of Life; and Health Economic Outcomes (MRU)
Condition | Intervention | Phase |
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Type 1 Diabetes |
Device: MiniMed Paradigm REAL-Time System |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The STAR 3 Study - A Prospective, Randomized, Two-Arm Study to Compare the Efficacy of the MiniMed Paradigm REAL-Time System Versus Multiple Daily Injections (MDI) in Subjects Naive to Insulin Pump Therapy |
Enrollment: | 495 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1. 722: Active Comparator
722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
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Device: MiniMed Paradigm REAL-Time System
Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter
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2. MDI: No Intervention
MDI arm: MDI using Lantus and NovoLog/NovoRapid for 1 year
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Glycemic control remains a significant challenge for adult, adolescent and pediatric Type 1 diabetics. The current first line standard of care continues to be MDI therapy utilizing a long acting analog insulin. 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 future therapy change recommendations. The MiniMed Paradigm REAL-Time 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. Additionally, data can be downloaded from the monitor to a personal computer, using appropriate software, so that the patient and physician can see a complete picture of glucose trends over time. The System will also alert users of high and low glucose levels, and allow subjects and their clinicians to treat to a therapeutic target HbA1c under carefully monitored conditions.
Subjects wearing the MiniMed Paradigm REAL-Time System will be compared to subjects that continue on their current MDI therapy, that includes a long acting analog insulin, over a 12 month period to evaluate changes in glycemic control (HbA1c).
Ages Eligible for Study: | 7 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Stephen N Davis, MD | Vanderbilt University Medical School |
Principal Investigator: | William V Tamborlane, MD | Yale University |
Study Director: | Scott W Lee, MD | Medtronic MiniMed |
Responsible Party: | Medtronic Diabetes ( John Mastrototaro, VP, Global Clinical, Scientific and Health Affairs ) |
Study ID Numbers: | CEP179/Z25 |
Study First Received: | January 2, 2007 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00417989 |
Health Authority: | United States: Food and Drug Administration |
Glycemic control Sensor |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Immune System Diseases |