Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:7 - 70
Updated:5/25/2018
Start Date:January 2007
End Date:June 2010

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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 Naïve to Insulin Pump Therapy

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, Area Under the Curve (AUC); Quality of Life; and Health Economic Outcomes (MRU)

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).

Inclusion Criteria:

- Aged 7 to 70 years

- Has been treated by the Principal Investigator or referring physician within the same
practice for at least six months prior to screening

- Is fluent in speaking, reading and understanding English

- Has Type 1 diabetes mellitus, diagnosed by c-peptide, insulin antibodies, or prior
documented DKA, or by a clinical picture consistent with Type 1 diabetes and excluding
type 2 diabetes i.e. - previous ketosis as evidenced by laboratory evidence of urine
ketones or alteration in bicarbonate levels with corresponding increased glucose
levels, diagnosed at least 6 months prior to study entry, or has a fasting C-peptide
that meet criteria of 110% of lower limit of normal or 200% of lower limit of normal
in the presence of renal insufficiency (creatinine clearance < 50ml/min) at screening

- Is insulin infusion pump naїve or has not used an insulin pump within the last three
years

- Currently is treated with insulin administration by injection > (greater or equal to)
three (3) times daily and therapy has included the use of a long acting analog insulin
for at least the previous 3 months prior to screening

- Performs fingerstick blood glucose (BG) testing an average of four times per day in
the 30 days prior to screening

- Within 6 months prior to study entry and at Screening Visit 1, subject has a
documented A1c level =/> 7.4% and =/< 9.5%

Exclusion Criteria:

- Is pregnant or planning to become pregnant during the course of the study

- Has suffered two or more documented events of severe hypoglycemia without warning of
impending low glucose levels, within the previous 12 months

- Currently using oral or injectable steroids or immunosuppressant medications

- Use of any other pharmaceutical agent, other than insulin to treat diabetes, within
the three months prior to screening;

- Has a current history of alcohol or drug abuse

- Has a history of myocardial infarction, unstable angina, coronary artery bypass
surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular
accident (CVA), or thromboembolic disease in the 3 months prior to screening

- Has uncontrolled hypertension (diastolic blood pressure >100 mmHg and/or sustained
systolic level [3 successive readings] > 160). Subjects who are taking
antihypertensive medication will not be excluded provided they are maintained at a
stable dose for 3 months prior to screening

- Has serious or unstable medical or psychological conditions (e.g., eating disorders,
clinical depression, anxiety disorder) which, in the opinion of the Investigator,
would compromise the subject's safety or successful participation in the study

- Is undergoing renal dialysis, including hemodialysis and continuous ambulatory
peritoneal dialysis (CAPD)

- Has evidence of any allergic dermatological condition (e.g., severe adhesive
sensitivity)

- Has recurrent episodes of skin infections or history of staphylococcus infection
carrier state

- Has potential for lack of compliance or any other issue that may preclude the subject
from satisfactory participation in the study, based on Investigatory judgment
We found this trial at
27
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7102 Mineral Point Road
Madison, Wisconsin 53717
1650
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Madison, WI
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Chapel Hill, North Carolina 27599
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
2375
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Philadelphia, PA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
827
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Portland, OR
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
2244
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Rochester, NY
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Asheville, North Carolina 28803
2005
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Asheville, NC
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Boston, Massachusetts 02215
2578
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Boston, MA
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1775 Aurora Court
Boulder, Colorado 80045
825
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Boulder, CO
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
1959
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Columbus, OH
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2199
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Durham, NC
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Grand Rapids, Michigan 49503
1839
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Grand Rapids, MI
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115 Heart Drive
Greenville, North Carolina 27834
2288
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725
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Idaho Falls, ID
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10550 North Torrey Pines Road
La Jolla, California 92037
92
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La Jolla, CA
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Lexington, Kentucky 40503
1879
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Lexington, KY
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1450 Northwest 10th Avenue
Miami, Florida 33136
2320
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Miami, FL
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
1763
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
2486
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New Haven, CT
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21
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Orange, CA
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Rochester, Minnesota 55905
1524
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Rochester, MN
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Roswell, Georgia 30076
1917
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Roswell, GA
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Saint Louis, Missouri 63110
1568
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Saint Louis, MO
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Saint Louis Park, Minnesota 55416
1505
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345 Smith Avenue North
Saint Paul, Minnesota 55102
1516
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Salt Lake City, Utah 84108
577
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575 West 8th Avenue
Vancouver, British Columbia V5Z 1M9
1081
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Vancouver,
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8533 East 32nd Street North
Wichita, Kansas 67211
1187
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Wichita, KS
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