Clinical trial NCT00417989: Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy
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 Naïve to Insulin Pump Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Glycemic control
Sensor
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2007-01-04
Enrollment: 485
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in A1c From Baseline to 52 Weeks
timeFrame: Baseline and 52 weeks
Secondary outcomes:
measure: Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52;
timeFrame: Baseline and 52 weeks
measure: Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52
timeFrame: Baseline and 52 weeks
measure: Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52;
timeFrame: Baseline and 52 weeks
measure: Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52
timeFrame: Baseline and 52 weeks
measure: Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score
timeFrame: Baseline and 52 weeks
measure: Health Economic Outcome
timeFrame: Baseline and 52 weeks
measure: Quality of Life - Short Form-36 (SF-36v2™), General Health
timeFrame: Baseline and 52 Weeks
measure: Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy
timeFrame: Baseline and 52 Weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Institute
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County (CHOC)
state: California
city: Boulder
country: United States
facility: Barbara Davis Center, University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Miami
country: United States
facility: Diabetes Research Institute (DRI)
state: Florida
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Wichita
country: United States
facility: Mid-America Diabetes Associates
state: Kansas
city: Lexington
country: United States
facility: Kentucky Diabetes Endocrinology Center
state: Kentucky
city: Boston
country: United States
facility: Joslin Clinic
state: Massachusetts
city: Grand Rapids
country: United States
facility: DeVos Children's Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis Park
country: United States
facility: Minnesota International Diabetes Center
state: Minnesota
city: Saint Paul
country: United States
facility: Children's Hospital of St. Paul
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Asheville
country: United States
facility: Mountain Diabetes & Endocrine Center
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center Diabetes Research Clinic
state: North Carolina
city: Greenville
country: United States
facility: Diabetes and Obesity Center, East Carolina University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Salt Lake City
country: United States
facility: Utah Diabetes Center
state: Utah
city: Madison
country: United States
facility: University of Wisconsin Health West
state: Wisconsin
city: Vancouver
country: Canada
facility: Endocrine Research, Inc.
state: British Columbia
city: St. John's
country: Canada
facility: Health Science Center Memorial Hospital of Newfoundland
state: Newfoundland and Labrador
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital - UHN
state: Ontario
Study officials:
affiliation: University of Maryland, Baltimore
name: Stephen N Davis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: William V Tamborlane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medtronic Minimed
name: Scott W Lee, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.