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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

September 8, 2010
March 29, 2011
November 2010
January 2011   (final data collection date for primary outcome measure)
Evaluate capability to follow glucose concentration changes over 15 consecutive days [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01198678 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Feasibility Study to Assess the Safety and Functionality of the GluSense Continuous Glucose Monitor in Diabetic Patients
Feasibility Study to Assess the Safety and Functionality of the GluSense-LTone 2e3 Continuous Glucose Monitor in Diabetic Patients

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Diabetes
Dietary Supplement: Boost Nutritional Supplement
Boost- Nutritional Supplement
Other Name: boost HP
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
February 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
NCT01198678
Slovenia-UMC-001
Yes
Dr. Tehila Hyman, GluSense Ltd
GluSense Ltd
Not Provided
Principal Investigator: Tadej Batellino, Prof University Medical Centre Ljubljana
GluSense Ltd
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP