Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Type 1 Diabetes
Interventions
DEVICE

GlucoMenDay

"Subjects will receive a standardized lunch (100 g of CHO), administration of insulin will be performed by the subject based on insulin to carbohydrate ratio.~An intravenous catheter will be inserted in one forearm and venous sampling will start 1 hour after lunch ingestion. Arterialized-venous blood sampling will be performed every 15 minutes for a period of two hours. Samples will be analyzed for glucose using the Super GL; concomitantly capillary measurements using the GlucoCard G Meter will be performed.~This procedure can be performed on days 3-4 of monitoring; each subject randomized to Procedure A undergoes this procedure once."

DEVICE

GlucoMenDay

"Subjects will receive a standard breakfast (75g CHO), the usual morning insulin dose will be post-poned. An increased dose of rapid-acting insulin analogue aiming to produce minor hypoglycaemia based on insulin to carbohydrate ratio will be injected subcutaneously. Arterialized-venous sampling will be performed every 10 minutes for a period of two hours.~Samples will be analyzed for glucose using the Super GL; concomitantly, capillary measurements using the GlucoCard G Meter will be performed.~This procedure will be performed on days 2 and 4 of monitoring; each subject randomized to Procedure B undergoes this procedure twice."

Trial Locations (1)

8036

Medical University of Graz, Graz

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Menarini Group

INDUSTRY

lead

Medical University of Graz

OTHER

NCT01407315 - Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor | Biotech Hunter | Biotech Hunter