Feasibility Study to Determine the Optimal Calibration Method for Glucose Sensors (REACT4SENSOR)

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: Insulin dosing; Device: Glucose sensors IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Insulin dosing and glucose sensors; 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.

Drug: Insulin dosing; Other Names: Humalog; Lantus; Levemir; Subjects will use their daily usual insulin:; Novorapid; Sensors:; IR-Glucose Reader (Joanneum Research, Austria); IR-CGM (IMM, Germany); Device: Glucose sensors IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: European Commission

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: June 3, 2014
• First Posted (Estimate): June 4, 2014

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: REACTforSENSOR