Status:
COMPLETED
Feasibility Study to Assess the Safety and Functionality of the GluSense Continuous Glucose Monitor in Diabetic Patients
Lead Sponsor:
GluSense Ltd
Conditions:
Diabetes
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 le...
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 saf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01198678
Start Date
November 1 2010
End Date
February 1 2011
Last Update
March 31 2011
Active Locations (1)
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1
University medical Center Ljubljana
Ljubljana, Slovenia, SI-1000