Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor
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| First Received Date ICMJE | May 23, 2011 | ||||
| Last Updated Date | April 19, 2012 | ||||
| Start Date ICMJE | November 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Accuracy of the GlucoMenDay [ Time Frame: 1 week ] [ Designated as safety issue: No ] Assessed by methods such as the Clarke Error Grid Analysis (EGA), CG-EGA, MARD, MAD |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01407315 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Safety of the GlucoMenDay System [ Time Frame: 1 week ] [ Designated as safety issue: Yes ] Assessment of patients with local skin reaction at insertion site after 100 hours of continuous monitoring |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor | ||||
| Official Title ICMJE | Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor | ||||
| Brief 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. |
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| 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:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Type 1 Diabetes | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01407315 | ||||
| Other Study ID Numbers ICMJE | GMD_03 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Pieber Thomas, MD, Medical University of Graz | ||||
| Study Sponsor ICMJE | Medical University of Graz | ||||
| Collaborators ICMJE | Menarini Group | ||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Graz | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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