Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211510
Status:
COMPLETED
Last Update Posted:
2017-06-12
First Post:
2005-09-12
Brief Title:
Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes
Sponsor:
Medtronic Diabetes
Organization:
Medtronic Diabetes
Study Overview
Official Title:
Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes A Multi-center Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-05
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:
STAR1
Brief Summary:
The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm 722 System which is a glucose sensor-augmented insulin pump can improve glycemic control when compared to subjects using the Paradigm 715 insulin pump only
Detailed Description:
Glycemic control remains a significant challenge for both adult and adolescent Type 1 diabetics 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 therapy change recommendations for the future The Paradigm 722 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 This System will alert users to high and low glucose levels and will allow subjects and their clinicians to treat to a therapeutic target HbA1c under monitored conditions
Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm 715 Insulin Pump over a 6 month period to evaluate changes in glycemic control HbA1c
Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm 715 Insulin Pump over a 6 month period to evaluate changes in glycemic control HbA1c
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None