Feasibility Study to Determine the Optimal Calibration Method for Glucose Sensors

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Drug: Insulin dosing; Device: Glucose sensors IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)

• Registration Number: NCT02155023
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-04
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin dosing and glucose sensors	Insulin dosing	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.
Insulin dosing and glucose sensors	Glucose sensors IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)	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.

Primary Outcome Measures

Name	Time	Method
difference between calibrated measurements and reference	12 hours	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)

Secondary Outcome Measures

Name	Time	Method
evaluate necessary run-in procedures by assessment of error over time	12 hours	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.

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria