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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Dietary supplement: Boost Nutritional Supplement

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
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, SI-1000
    • University Medical Center Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate capability to follow glucose concentration changes over 15 consecutive days	3 weeks

Collaborators and Investigators

• Sponsor: GluSense Ltd
• Investigators: Principal Investigator: Tadej Batellino, Prof, University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: September 8, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Estimate): March 31, 2011
• Last Update Submitted That Met QC Criteria: March 29, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: Slovenia-UMC-001