A Phase 1 interventional study of GlucoMenDay and GlucoMenDay in Type 1 Diabetes, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-20.
Sponsored by Medical University of Graz · Phase 1, Interventional, and Diagnostic
Monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, equipped with the GlucoMen®Day system, over up to 100 hours observation after implantation of the microdialysis probe. Different meal/hypo procedures will be performed at the study centre.
This is a monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, who will be equipped with the GlucoMen®Day system.
Each subject will be investigated for up to 100 hours after implantation of the microdialysis probe.
In order to verify the clinical effectiveness of the GlucoMenDay the subjects will be asked to perform a total of six self testing measurements per day using the GlucoCard G-Meter according to the following scheme:
Subjects will be asked to come to the research facility every day to obtain a venous blood sample and to check system functioning.
Subjects will be randomized either to Procedure A - Multiple sampling or Procedure B - Meal/Insulin test.
Procedure A - Multiple sampling:
This procedure can be performed at days 2-4 of the study period. 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.
Procedure B - Meal/Insulin test:
This procedure will be performed on days 2 and four of the experiment. Subjects randomized to procedure B will be asked to undergo this investigation twice.
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.
On day 5 subjects will return to the clinical trial unit for collection of a final blood sample and removal of the device.
Subjects will be asked to come to the research facility at 48 and 72 hours after removal of the device for an evaluation of local site reactions.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
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Exclusion Criteria:
Device: GlucoMenDay
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.
Also known as: Continuous Glucose Monitoring
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.
Also known as: Continuous Glucose Monitoring
Accuracy of the GlucoMenDay
Assessed by methods such as the Clarke Error Grid Analysis (EGA), CG-EGA, MARD, MAD
Time frame: 1 week
Safety of the GlucoMenDay System
Assessment of patients with local skin reaction at insertion site after 100 hours of continuous monitoring
Time frame: 1 week
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Medical University of Graz