Feasibility Study to Determine the Optimal Calibration Method for Glucose Sensors

Diabetes Clinical Trial

— REACT4SENSOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155023
• Other study ID #: REACTforSENSOR
• Status: Completed
• Phase: N/A
• First received: February 7, 2014
• Last updated: March 25, 2015
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Insulin dosing

Device:
• Glucose sensors IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	European Commission

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Distribution of the glucose values	The glucose sensors will be tested over a range of different reference glucose values. The distribution of the glucose values (hypo-normo-hyperglycaemia) will be taken into account when calculating the difference (error) between the sensor- and reference value.	12 hours	Yes
Other	Malfunction of the systems	Based on the fact that the sensors are in a very early development stage possible malfunctions of the sensor systems will be recorded and categorized to: mechanical, electrical, software and other malfunctions	12 hours	Yes
Primary	difference between calibrated measurements and reference	The calibrated sensor signals will be compared with the reference blood glucose values. The difference between the calibrated sensor signal and the reference values will be calculated (which corresponds to the error of the sensor signal)	12 hours	Yes
Secondary	evaluate necessary run-in procedures by assessment of error over time	Once the difference between sensor signal and the reference values is calculated these values will be investigated by looking at the data over time which enables to detect a possible change of the difference.	12 hours	Yes

External Links

•   Website of the project which is funded by the European Commission