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Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02614768
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : March 3, 2016
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:
The purpose of this study is to assess accuracy and reliability of the SPIDIMAN CGM sensor system with regard to values as measured by Super GL and compare these results with similar evaluations of the Medtronic MiniMed 640G system, the Abbott FreeStyle Libre Flash Sensor and the DexCom G4 Platinum Sensor in patients with type 1 Diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Glucose Sensor Not Applicable

Detailed Description:
The study is a single-center open-label study in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) therapy. The study will include a total of 12 subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions
Study Start Date : July 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Glucose Sensor
Continuous subcutaneous glucose monitoring using four different CGM systems in parallel will be performed throughout the study. Insulin therapy will be performed by the subjects themselves, as under daily life conditions. For the hypoglycaemia experiment an increased insulin bolus will be administered with meals (180% of the subject's calculated mealtime dose).
Device: Glucose Sensor
The investigational intervention is CGM monitoring using four different CGM systems. Three of the four CGM devices which are used will be CGM systems which have received CE certification (Dexcom G4 Platinum, Medtronic MiniMed 640G system, Abbott FreeStyle Libre Flash). The SPIDIMAN sensor will be used for the first time in human subjects, does not yet have received CE certification and will be given an identifying label in addition to being labelled "for investigative use only".

Primary Outcome Measures :
  1. Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15%. [ Time Frame: 36 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed consent obtained after being advised of the nature of the study
  • Male or female aged ≥18 years
  • Type 1 diabetes for at least 6 months according to the WHO definition
  • Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months
  • Body Mass Index (BMI) < 35 kg/m²
  • Willing and able to wear 5 CGM devices for the duration of the study and undergo all study procedures.
  • HbA1c ≤ 86 mmol/mol

Exclusion Criteria:

  • Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
  • Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
  • Any mental condition rendering the subject incapable of giving his consent
  • Subject is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
  • Subject may not use acetaminophen (paracetamol) while participating in the study
  • Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study.
  • Subject is actively enrolled in another clinical trial
  • Known adrenal gland problem, pancreatic tumour, or insulinoma
  • Inability of the subject to comply with all study procedures
  • Inability of the subject to understand the patient information.
  • Subject donated blood in the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02614768

Sponsors and Collaborators
Medical University of Graz
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Principal Investigator: Julia Mader, Prof. Dr. Medical University of Graz
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Responsible Party: Medical University of Graz Identifier: NCT02614768    
Other Study ID Numbers: SPIDIMAN_01
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016
Keywords provided by Medical University of Graz:
Glucose Monitoring System
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases