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

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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)

Key facts

Study ID

NCT00417989

Run by

Medtronic MiniMed, Inc.

People needed

485

Starts

2007-01-01

Expected to finish

2010-06-01

Last updated by the study team

2018-05-23

Who can join

Age: 7 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Scripps Institute — La Jolla, California, United States
• Children's Hospital of Orange County (CHOC) — Orange, California, United States
• Barbara Davis Center, University of Colorado — Boulder, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Diabetes Research Institute (DRI) — Miami, Florida, United States
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
• Mid-America Diabetes Associates — Wichita, Kansas, United States
• Kentucky Diabetes Endocrinology Center — Lexington, Kentucky, United States
• Joslin Clinic — Boston, Massachusetts, United States
• DeVos Children's Hospital — Grand Rapids, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Minnesota International Diabetes Center — Saint Louis Park, Minnesota, United States
• Children's Hospital of St. Paul — Saint Paul, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• University of Rochester — Rochester, New York, United States
• Mountain Diabetes & Endocrine Center — Asheville, North Carolina, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center Diabetes Research Clinic — Durham, North Carolina, United States
• Diabetes and Obesity Center, East Carolina University — Greenville, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Utah Diabetes Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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