Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): GlucoMenDay; GlucoMenDay
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Other intervention name(s): Continuous Glucose Monitoring; Continuous Glucose Monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Continuous subcutaneous glucose monitoring; Type 1 Diabetes