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

NCT00417989 | Completed Results DMC

• 1 other identifier: CEP179/Z25
• Study Type: interventional
• Target: 485
• Locations: 2 countries
• Sites: 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)

Conditions

Type 1 Diabetes

Keywords

Glycemic control; Sensor

Outcome Measures

Primary Outcomes (1)

• Change in A1c From Baseline to 52 Weeks

  Change is defined as A1c at Week 52 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.

  Baseline and 52 weeks

Secondary Outcomes (8)

• Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52;

  Baseline and 52 weeks

• Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52

  Baseline and 52 weeks

• Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52;

  Baseline and 52 weeks

• Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52

  Baseline and 52 weeks

• Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score

  Baseline and 52 weeks

Study Arms (2)

722 sensor augmented pump

EXPERIMENTAL

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

Device: MiniMed Paradigm REAL-Time System

Multiple Daily Injections (MDI)

NO INTERVENTION

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

Interventions

MiniMed Paradigm REAL-Time System DEVICE

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

Also known as: Medtronic Paradigm REAL-Time System

722 sensor augmented pump

Eligibility Criteria

• Age: 7 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (30)

Scripps Institute

La Jolla, California, 92037, United States

Location

Children's Hospital of Orange County (CHOC)

Orange, California, 92864-3874, United States

Location

Barbara Davis Center, University of Colorado

Boulder, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06522, United States

Location

Diabetes Research Institute (DRI)

Miami, Florida, 33136, United States

Location

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

Mid-America Diabetes Associates

Wichita, Kansas, 67211, United States

Location

Kentucky Diabetes Endocrinology Center

Lexington, Kentucky, 40503, United States

Location

Joslin Clinic

Boston, Massachusetts, 02215, United States

Location

DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Minnesota International Diabetes Center

Saint Louis Park, Minnesota, 55416, United States

Location

Children's Hospital of St. Paul

Saint Paul, Minnesota, 55102, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Rochester

Rochester, New York, 14644, United States

Location

Mountain Diabetes & Endocrine Center

Asheville, North Carolina, 28801, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center Diabetes Research Clinic

Durham, North Carolina, 27710, United States

Location

Diabetes and Obesity Center, East Carolina University

Greenville, North Carolina, 27834, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Utah Diabetes Center

Salt Lake City, Utah, 84108, United States

Location

University of Wisconsin Health West

Madison, Wisconsin, 53717, United States

Location

Endocrine Research, Inc.

Vancouver, British Columbia, V6E1M7, Canada

Location

Health Science Center Memorial Hospital of Newfoundland

St. John's, Newfoundland and Labrador, A1B3V6, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7M5L2, Canada

Location

Toronto General Hospital - UHN

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

• 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.

  PMID: 25175313 DERIVED

• 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.

  PMID: 20587585 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Scott Lee, M.D.
• Organization: Medtronic

scott.w.lee@medtronic.com

8185764204

Study Officials

• Stephen N Davis, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• William V Tamborlane, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Scott W Lee, MD

  Medtronic Minimed

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: May 23, 2018
• Results First Posted: March 10, 2011

Record last verified: 2018-05

Locations

CA (4); US (26)