Feasibility Study to Assess the Safety and Functionality of the GluSense Continuous Glucose Monitor in Diabetic Patients

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: NCT01198678
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : March 31, 2011
Information provided by:
GluSense Ltd

Brief Summary:

Currently marketed CGM sensors have an approved functional lifetime of up to 1 week. Pre-clinical studies have demonstrated that GluSense-LTone 2e3 sensors may be used to accurately monitor glucose levels for 30 days. The purpose of this study is to assess the safety and functionality of the device in human patients for consecutive 15 days.

GluSense-LTone 2e3 as long term CGM, will require less sensor replacements and calibration, meaning less patient interventions, and is therefore will be much more user friendly. Moreover, GluSense-LTone 2e3 shows potentially increased accuracy, especially in the critically important hypoglycemic range, meaning that better management of patient's condition may be attained.

Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Boost Nutritional Supplement Phase 1

Detailed Description:
GluSense-LTone 2e3 is a continuous glucose monitoring (CGM) system. It is a semi-invasive, optical fiber-based device with a lifetime of up to one month. The purpose of this study is to assess the safety, accuracy, calibration requirements and effective lifetime of the device.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Feasibility Study to Assess the Safety and Functionality of the GluSense-LTone 2e3 Continuous Glucose Monitor in Diabetic Patients
Study Start Date : November 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

Intervention Details:
  • Dietary Supplement: Boost Nutritional Supplement
    Boost- Nutritional Supplement
    Other Name: boost HP

Primary Outcome Measures :
  1. Evaluate capability to follow glucose concentration changes over 15 consecutive days [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

  • Male or female patients between 18 and 50 years of age
  • Patients with type 1 diabetes mellitus.
  • The ability to read, understand and sign an informed consent form. Written consent must be obtained prior to initiation of study procedures

Exclusion Criteria:

Patients who meet any of the following exclusion criteria are not to be enrolled in this study:

  • Clinical significant illness that can compromise patient's health during study such as:

    • Significant current heart disease
    • Significant Liver or kidney disease
    • HIV infection
    • Hepatitis B or Hepatitis C infection
    • Malignancy
    • Major allergic skin disease including plaster allergies
    • Significant allergic disorders
  • Current or recent significant skin conditions (e.g. eczema, psoriasis,).
  • Presence of skin markings/ abnormalities around implantation site that will interfere with the skin assessment e.g. tattoos, piercings, birthmark, sunburn
  • Current alcohol or substance use judged by the IP to potentially interfere with patient study compliance.
  • Routine administration of Steroid based medications.
  • Patients currently taking part in any other clinical trial using an investigational product within 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): NCT01198678

University medical Center Ljubljana
Ljubljana, Slovenia, SI-1000
Sponsors and Collaborators
GluSense Ltd
Principal Investigator: Tadej Batellino, Prof University Medical Centre Ljubljana

Responsible Party: Dr. Tehila Hyman, GluSense Ltd Identifier: NCT01198678     History of Changes
Other Study ID Numbers: Slovenia-UMC-001
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: March 31, 2011
Last Verified: December 2010