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CompletedNCT01198678Updated Mar 31, 2011

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

A Phase 1 interventional study of Boost Nutritional Supplement in Diabetes, sponsored by GluSense Ltd. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2011-03-31.

Sponsored by GluSense Ltd · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

This is the only study on the registry with GluSense Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Interventions

  • Dietary supplementBoost Nutritional Supplement

    Boost- Nutritional Supplement

    Also known as: boost HP

06

What researchers measure

Primary outcomes

  1. Evaluate capability to follow glucose concentration changes over 15 consecutive days

    Time frame: 3 weeks

07

Study locations

1 site
  • University medical Center Ljubljana
    Ljubljana, SI-1000, Slovenia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01198678
Lead sponsor
GluSense Ltd
First posted
Sep 10, 2010
Start date
Nov 2010
Primary completion
Jan 2011
Completion
Feb 2011
Last update
Mar 31, 2011

Study contacts

Tadej Batellino, Prof
principal investigator · University Medical Centre Ljubljana

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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