Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499954
Status:
COMPLETED
Last Update Posted:
2007-07-12
First Post:
2007-07-11
Brief Title:
Investigation of Correlation Between Concentrations of Glucose in Blood and Interstitial Fluid in Type 1 Diabetics
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
An Open Mono-Centre Trial to Investigate the Correlation Between Concentrations of Glucose in Arterialized Venous Blood and Subcutaneous Interstitial Fluid Applying Different Extracorporeal Sensor Techniques in Type 1 Diabetics
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a mono-centre trial performed at the Center for Clinical Research at the Medical University Graz There will be a screening information and a study visitIn the study visit arterialized venous blood glucose values will be monitored and subcutaneous sampling of interstitial fluid ISF with microdialysis for glucose determination will be performed Additionally to the laboratory analysis of the subcutaneous glucose samples the glucose will be measured with extracorporeal on-line sensors and two marketed devices Guardian RT and Glucoday SThe study visit will last 30 hours starting with the insertion of microdialysis catheters in the abdominal subcutaneous tissue and the insertion of the catheters for the Glucoday S system and Guardian RT system The primary hypothesis of the study is Interstitial fluid glucose concentration profiles correlate to the arterialized venous blood glucose concentration profile in type 1 diabetic subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None