Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441129
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2007-02-27
Brief Title:
Obtain a Good Blood Glucose Control With the Paradigm Real Time System
Sponsor:
Medtronic Diabetes
Organization:
Medtronic Diabetes
Study Overview
Official Title:
To Assess Whether Type 1 Diabetic Patients Treated With M D I and in Poor Metabolic Control Can Improve Using the Paradigm Real Time System Compared to Self-Monitoring Blood Glucose and Continuous Subcutaneous Insulin Infusion
Status:
COMPLETED
Status Verified Date:
2018-12
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:
RTD
Brief Summary:
In this study subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump PRT an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor or conventional CSII and compared glycemic outcomes after 6 months
Detailed Description:
The long-term clinical benefit of tight glycemic control in people with diabetes is well known HbA1c generally assesses the averagelong term quality of glycemic control it has been clearly demonstrated that a target of HbA1c at 70 or less has benefits for diabetic patients
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