Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor

This study has been completed.
Sponsor:
Collaborator:
Menarini Group
Information provided by (Responsible Party):
Pieber Thomas, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01407315
First received: May 23, 2011
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Device: GlucoMenDay
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: November 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GlucoMenDay - Multiple sampling (A) 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.

Other Name: Continuous Glucose Monitoring
Experimental: GlucoMenDay - Meal/Insulin test (B) Device: GlucoMenDay

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 Name: Continuous Glucose Monitoring

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407315

Locations
Austria
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Menarini Group
Investigators
Principal Investigator: Thomas R. Pieber, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Pieber Thomas, MD, MD, Prof. of Medicine, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01407315     History of Changes
Other Study ID Numbers: GMD_03
Study First Received: May 23, 2011
Last Updated: April 19, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Graz:
Continuous subcutaneous glucose monitoring
Type 1 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2014