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

This study has been completed.
Sponsor:
Information provided by:
GluSense Ltd
ClinicalTrials.gov Identifier:
NCT01198678
First received: September 8, 2010
Last updated: March 29, 2011
Last verified: December 2010
  Purpose

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 Intervention Phase
Diabetes
Dietary Supplement: Boost Nutritional Supplement
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Feasibility Study to Assess the Safety and Functionality of the GluSense-LTone 2e3 Continuous Glucose Monitor in Diabetic Patients

Resource links provided by NLM:


Further study details as provided by GluSense Ltd:

Primary Outcome Measures:
  • Evaluate capability to follow glucose concentration changes over 15 consecutive days [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Boost Nutritional Supplement
    Boost- Nutritional Supplement
    Other Name: boost HP
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01198678

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

No publications provided

Responsible Party: Dr. Tehila Hyman, GluSense Ltd
ClinicalTrials.gov Identifier: NCT01198678     History of Changes
Other Study ID Numbers: Slovenia-UMC-001
Study First Received: September 8, 2010
Last Updated: March 29, 2011
Health Authority: Slovenia: Ministry of Health

ClinicalTrials.gov processed this record on July 24, 2014