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

NCT ID: NCT00417989

Last Updated: 2018-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 485 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-06-30

Brief Summary

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)

Detailed Description

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).

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

722 sensor augmented pump

722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year

Group Type: EXPERIMENTAL

MiniMed Paradigm REAL-Time System

Intervention Type: DEVICE

Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter

Multiple Daily Injections (MDI)

MDI arm: Continue with current MDI therapy using Lantus and NovoLog/NovoRapid for 1 year

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MiniMed Paradigm REAL-Time System

Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter

Intervention Type: DEVICE

Other Intervention Names

Medtronic Paradigm REAL-Time System

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen N Davis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

William V Tamborlane, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Scott W Lee, MD

Role: STUDY_DIRECTOR

Medtronic Minimed

Locations

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

University of Wisconsin Health West

Madison, Wisconsin, United States

Endocrine Research, Inc.

Vancouver, British Columbia, Canada

Health Science Center Memorial Hospital of Newfoundland

St. John's, Newfoundland and Labrador, Canada

Kingston General Hospital

Kingston, Ontario, Canada

Toronto General Hospital - UHN

Toronto, Ontario, Canada

Countries

United States; Canada

References

Perkins BA, Halpern EM, Orszag A, Weisman A, Houlden RL, Bergenstal RM, Joyce C. Sensor-augmented pump and multiple daily injection therapy in the United States and Canada: post-hoc analysis of a randomized controlled trial. Can J Diabetes. 2015 Feb;39(1):50-4. doi: 10.1016/j.jcjd.2014.03.003. Epub 2014 Aug 29.

Reference Type: DERIVED

PMID: 25175313 (View on PubMed)

Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Peoples T, Perkins BA, Welsh JB, Willi SM, Wood MA; STAR 3 Study Group. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med. 2010 Jul 22;363(4):311-20. doi: 10.1056/NEJMoa1002853. Epub 2010 Jun 29.

Reference Type: DERIVED

PMID: 20587585 (View on PubMed)

Other Identifiers

CEP179/Z25

Identifier Type: -

Identifier Source: org_study_id