- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01407315
Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Graz, Austria, 8036
- Medical University of Graz
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Established diagnosis of type-1-diabetes
- Ability to provide informed consent
- Age 18-75 years
Exclusion Criteria:
- Subjects under anti-coagulant treatments
- Alcoholism
- Body mass index (BMI) > 32 kg/m2
- Inability to adhere to the protocol or to attend the required follow- up visits and tests
- Diseases or conditions of the abdominal wall which, in the opinion of Clinician might contraindicate the insertion of the hypodermic needle into the subcutaneous tissue
- Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study
- Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
- Subjects currently participating in a clinical study
- Pregnancy or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GlucoMenDay - Multiple sampling (A)
|
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.
Other Names:
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 Names:
|
Experimental: GlucoMenDay - Meal/Insulin test (B)
|
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.
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of the GlucoMenDay
Time Frame: 1 week
|
Assessed by methods such as the Clarke Error Grid Analysis (EGA), CG-EGA, MARD, MAD
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of the GlucoMenDay System
Time Frame: 1 week
|
Assessment of patients with local skin reaction at insertion site after 100 hours of continuous monitoring
|
1 week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas R. Pieber, MD, Medical University of Graz
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMD_03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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