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

NCT01198678 | Completed Phase 1 DMC

• 1 other identifier: Slovenia-UMC-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Evaluate capability to follow glucose concentration changes over 15 consecutive days

  3 weeks

Interventions

Boost Nutritional Supplement DIETARY_SUPPLEMENT

Boost- Nutritional Supplement

Also known as: boost HP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GluSense Ltd: lead

Study Sites (1)

University medical Center Ljubljana

Ljubljana, SI-1000, Slovenia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tadej Batellino, Prof

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 10, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 31, 2011

Record last verified: 2010-12

Locations

SL (1)