NCT01013402

Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Gulhane School of Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-04-01
• Completion: 2009-08-01
• First posted: 2009-11-13
• Last updated: 2009-11-13

Locations

1 site across 1 country: Turkey (Türkiye)