Feasibility Study to Determine the Optimal Calibration Method for Glucose Sensors

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Two new glucose sensors (IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)) will be investigated to determine the optimal calibration method in patients with type 1 diabetes

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Graz
• Collaborator: European Commission
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Informed consent obtained after being advised of the nature of the study

• Male or female aged 18 to 75 years (both inclusive)

• The subject has Type 1 diabetes (as defined by WHO) for at least 24 months

• Body Mass Index (BMI) <= 35 kg/m2

Exclusion Criteria:

• Subject is actively enrolled in another clinical trial or took part in a study within 30 days

• Experienced recurrent severe hypoglycaemic unawareness (as judged by the investigator)

• A history of drug or alcohol dependence

• Positive result for HIV antibodies

• Positive result for Hepatitis B antigen or Hepatitis C antibodies

• Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator

• Patient is pregnant, or breast feeding during the period of the study

• Patient donated blood in the last 3 months