Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417989
Status:
COMPLETED
Last Update Posted:
2018-05-23
First Post:
2007-01-02
Brief Title:
Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs MDI in Subjects Naive to Insulin Pump Therapy
Sponsor:
Medtronic Diabetes
Organization:
Medtronic Diabetes
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR3
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None