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

Diabetes Clinical Trial

Official title:

Feasibility Study to Assess the Safety and Functionality of the GluSense-LTone 2e3 Continuous Glucose Monitor in Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198678
• Other study ID #: Slovenia-UMC-001
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2010
• Last updated: March 29, 2011
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: December 2010
• Source: GluSense Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes

Intervention

Dietary Supplement:
• Boost Nutritional Supplement
Boost- Nutritional Supplement

Locations

Country	Name	City	State
Slovenia	University medical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
GluSense Ltd

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate capability to follow glucose concentration changes over 15 consecutive days		3 weeks	Yes