Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes
Evaluate the usefulness of continuous glucose monitoring devices in terms of their ability to identify periods throughout the day when glucose varies significantly.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes|
- To collect sufficient glucose data by means of continuous glucose monitoring for the purpose of detecting clinically relevant alterations in blood glucose throughout a typical or modal day. [ Time Frame: 9 days ] [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Diabetes Insulin Treated
People with type 1 or type 2 diabetes on insulin.
Many CGM systems use a surrogate for blood glucose--tissue glucose or interstitial glucose. Interstitial fluid (ISF) is the medium for these approaches. A physiological lag in ISF glucose relative to capillary blood glucose has been noted, probably due to relatively low blood perfusion at the sampling site. 9 This physiological lag can result in an accuracy error, manifesting as a significant bias between blood and tissue glucose, particularly during periods of rapid glucose change. This lag error might be particularly meaningful when glucose is rapidly dropping towards hypoglycemia.
|United States, Minnesota|
|International Diabetes Center|
|Minneapolis, Minnesota, United States, 55416|
|Principal Investigator:||Roger S Mazze, PhD||International Diabetes Center at Park Nicollet|
|Principal Investigator:||Elinor (Ellie) S Strock, APRN BC||International Diabetes Center at Park Nicollet|