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:~before breakfast~before lunch~60-120 minutes after lunch~before dinner~60-120 minutes after dinner~at 3 AM~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.
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.