Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465881
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2007-04-24
Brief Title:
Develop Novel Methods to Display Report and Analyze CGM Data for Clinical Decision-Making in People With Diabetes
Sponsor:
HealthPartners Institute
Organization:
HealthPartners Institute
Study Overview
Official Title:
Observational Study of Interstitial Glucose Monitoring With the FreeStyle Navigator Continuous Glucose Monitoring CGM System to Develop Novel Methods for Displaying Reporting and Analyzing CGM Data for Clinical Decision-Making
Status:
COMPLETED
Status Verified Date:
2007-09
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:
None
Brief Summary:
The purpose of this study is to obtain sufficient continuous glucose monitoring CGM data in a manner that provides clinical information that is not available using conventional self-monitored blood glucose Currently a formal method does not exist for evaluating CGM data except for looking at each glucose reading across the days a CGM system has been worn and evaluating it based on clinical practice experience The hope is that a mathematical model can be developed that will enable health care providers to quickly and easily determine what changes in diabetes treatment need to be made after CGM data is obtained
Detailed Description:
There are two purposes to the study First to use an investigational device the FreeStyle Navigator Continuous Glucose Monitoring CGM System Abbott Diabetes Care to obtain sufficient longitudinal data in order to develop a method for reporting CGM data in a manner that provides clinical information that is not available using conventional SMBG The long-term goad is to determine the manner and degree to which CGM contributes to clinical decision-making Because of the evidence that glucose regulation may be indirectly related to blood pressure levels a second purpose of the study is to monitor variation in BP control by means of self-monitored BP
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