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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Boost Nutritional Supplement

Boost- Nutritional Supplement

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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boost HP

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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GluSense Ltd

Principal Investigators

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Tadej Batellino, Prof

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

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University medical Center Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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Slovenia-UMC-001

Identifier Type: -

Identifier Source: org_study_id