Develop Novel Methods to Display, Report and Analyze CGM Data for Clinical Decision-Making in People With Diabetes
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.
Device: CGM System for Type 1 and Type 2 Diabetes Mellitus
|Study Design:||Time Perspective: Prospective|
|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|
|Study Start Date:||January 2006|
|Study Completion Date:||April 2006|
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.
|United States, Minnesota|
|International Diabetes Center - Park Nicollet Health Services|
|Minneapolis, Minnesota, United States, 55416|
|Principal Investigator:||Roger S. Mazze, PhD||International Diabetes Center - Park Nicollet Institute|
|Principal Investigator:||Richard M. Bergenstal, MD||International Diabetes Center - Park Nicollet Institute|
|Principal Investigator:||Ellie S. Strock, RN BC-ANP||International Diabetes Center - Park Nicollet Institute|