An Open, Single-centre, Non-controlled Feasibility Study to Determine the Optimal Calibration Method for Glucose Sensors Used for Continuous Glucose Monitoring in Patients With Type 1 Diabetes

Feasibility Study to Determine the Optimal Calibration Method for Glucose Sensors

Sponsors

Lead sponsor: Medical University of Graz

Collaborator: European Commission

Source Medical University of Graz
Brief 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

Detailed Description

The subjects (Type 1 diabetes) will stay at the Clinical Research Centre for the whole period of the investigation (12 hours).

Continuous blood glucose monitoring will be performed using the IR-Glucose Reader system and/or the IR-CGM system based on microdialysis. In parallel blood glucose measurements will be performed every 15 min as reference. The measurements of the sensors will be calibrated with different schemes and the difference between the calibrated glucose readings and the reference blood glucose values will be determined.

Overall Status Completed
Start Date January 2014
Completion Date January 2015
Primary Completion Date January 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
difference between calibrated measurements and reference 12 hours
Secondary Outcome
Measure Time Frame
evaluate necessary run-in procedures by assessment of error over time 12 hours
Enrollment 8
Condition
Intervention

Intervention type: Drug

Intervention name: Insulin dosing

Arm group label: Insulin dosing and glucose sensors

Intervention type: Device

Intervention name: Glucose sensors IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)

Arm group label: Insulin dosing and glucose sensors

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Thomas R Pieber, MD Principal Investigator Medical University of Graz
Location
facility Medical University of Graz
Location Countries

Austria

Verification Date

March 2015

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Number Of Arms 1
Arm Group

Arm group label: Insulin dosing and glucose sensors

Arm group type: Experimental

Description: To test the glucose sensors different levels of glycemia are needed. To provoke different glycemic levels the following intervention will be performed: Lunch (with fast glucose absorption characteristics) will be served. Up to 30 minutes after the usual insulin dosing time, the subjects will take his/her lunch dose of insulin adjusted to the chosen lunch plus additional approximately 25% (in the range of 0-50% according to the discretion of the Investigator) of insulin - in order to provoke moderate postprandial hypoglycaemia with glucose values < 70 mg/dl.

Acronym REACT4SENSOR
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov