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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805506
|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|