Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy (STAR3)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00417989 |
Recruitment Status :
Completed
First Posted : January 4, 2007
Results First Posted : March 10, 2011
Last Update Posted : May 23, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | January 2, 2007 | |||||||||
First Posted Date ICMJE | January 4, 2007 | |||||||||
Results First Submitted Date ICMJE | December 24, 2010 | |||||||||
Results First Posted Date ICMJE | March 10, 2011 | |||||||||
Last Update Posted Date | May 23, 2018 | |||||||||
Study Start Date ICMJE | January 2007 | |||||||||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Change in A1c From Baseline to 52 Weeks [ Time Frame: Baseline and 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.
|
|||||||||
Original Primary Outcome Measures ICMJE |
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". | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
|
|||||||||
Original Secondary Outcome Measures ICMJE |
|
|||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy | |||||||||
Official Title ICMJE | 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 | |||||||||
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). |
|||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Not Applicable | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||||||||
Condition ICMJE | Type 1 Diabetes | |||||||||
Intervention ICMJE | 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
|
|||||||||
Study Arms ICMJE |
|
|||||||||
Publications * |
|
|||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Actual Enrollment ICMJE |
485 | |||||||||
Original Enrollment ICMJE |
336 | |||||||||
Actual Study Completion Date ICMJE | June 2010 | |||||||||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
Sex/Gender ICMJE |
|
|||||||||
Ages ICMJE | 7 Years to 70 Years (Child, Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Canada, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT00417989 | |||||||||
Other Study ID Numbers ICMJE | CEP179/Z25 | |||||||||
Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||
Responsible Party | Medtronic Diabetes | |||||||||
Study Sponsor ICMJE | Medtronic Diabetes | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
|
|||||||||
PRS Account | Medtronic Diabetes | |||||||||
Verification Date | May 2018 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |