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

Sponsor:	Medtronic Diabetes
Information provided by (Responsible Party):	Medtronic Diabetes
ClinicalTrials.gov Identifier:	NCT00417989

Purpose

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)

Condition	Intervention	Phase
Type 1 Diabetes	Device: MiniMed Paradigm REAL-Time System	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1 Hypoglycemia

Drug Information available for: Insulin Insulin beef

U.S. FDA Resources

Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:

Change in A1c From Baseline to 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52; [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory Blood Glucose (BG) by finger stick of less than 50 mg/dL (2.8 mmol/L). The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 52.
Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory BG by finger stick of less than 50 mg/dL (2.8 mmol/L). The rate evaluates the number of participants that experienced at least one severe hypoglycemia event and compares this number between the two study arms from Baseline to week 52. This measure identifies the rate or frequency of unique participant events.
Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52; [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 52.
Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 52.
Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
Difference of Baseline and 52 Weeks in Hypoglycemia Fear Scale (HFS) Overall Score between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with lower scores suggest higher satisfaction. Therefore, a negative number in the difference suggests higher satisfaction at 52 Weeks than Baseline.
Health Economic Outcomes (MRU) [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
Quality of Life - Short Form-36 (SF-36v2™), General Health [ Time Frame: Baseline and 52 Weeks ] [ Designated as safety issue: No ]
Difference of Baseline and 52 Weeks in Short Form-36 (SF-36v2™), General Health, between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.
Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy [ Time Frame: Baseline and 52 Weeks ] [ Designated as safety issue: No ]
Difference of Baseline and 52 Weeks in Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction with Type of Insulin Therapy, between the two study arms is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.

Enrollment:	485
Study Start Date:	January 2007
Study Completion Date:	June 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 722 sensor augmented pump 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year	Device: MiniMed Paradigm REAL-Time System Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter Other Name: Medtronic Paradigm REAL-Time System
No Intervention: Multiple Daily Injections (MDI) MDI arm: Continue with current MDI therapy using Lantus and NovoLog/NovoRapid for 1 year

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

Ages Eligible for Study:	7 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417989

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Sponsors and Collaborators

Medtronic Diabetes

Investigators

Principal Investigator:	Stephen N Davis, MD	University of Maryland
Principal Investigator:	William V Tamborlane, MD	Yale University
Study Director:	Scott W Lee, MD	Medtronic Minimed

More Information

No publications provided by Medtronic Diabetes

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Jun 29.

Responsible Party:	Medtronic Diabetes
ClinicalTrials.gov Identifier:	NCT00417989 History of Changes
Other Study ID Numbers:	CEP179/Z25
Study First Received:	January 2, 2007
Results First Received:	December 24, 2010
Last Updated:	December 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Diabetes:

Glycemic control
Sensor

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012