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

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