Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia
The purpose of this study is to compare the accuracies and the capillary and venous comparabilities of five different home glucose monitors; Optium Xceed, Contour Ts, Accu-chek Go, One Touch Select and Ez Smart in an adult population.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Phase IV Study to Compare the Accuracy and Precission of Five Different Home Glucose Monitors;Optium Xceed, Contour Ts, Accu-chek Go, One Touch Select and Ez Smart|
|Study Start Date:||December 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Experimental: volunteers for insulin hypoglycemia test
None of the subjects had diabetes mellitus or any other metabolic diseases. They were not taking any medicine and they did not have anemia or polycythemia. Also none of the patients had any condition causing hypoxia or any compromise in peripheral circulation.
Drug: Human insulin
The test was performed in the morning after an overnight fasting and the patients remained supine during the procedure. Two intravenous lines in both arms were established before the procedure. Venous blood was obtained for serum glucose before regular insulin (0.1 U/kg ) is injected and 30 and 45 minutes thereafter. If adequate hypoglycemia was not achieved at this period, a second dose of regular insulin (0.05U/kg) was injected intravenously. In subjects who had not reached the aimed hypoglycemia levels, the test was performed in another day with a higher initial insulin dosage (0.2U/kg).Drug: Human Insulin
0.1U/kg IV pulse.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013402
|Gulhane School of Medicine Department of Endocrinology and Metabolism|
|Ankara, Turkey, 06018|