Feasibility Study to Determine the Optimal Calibration Method for Glucose Sensors

NCT ID: NCT02155023

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-01-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Insulin dosing

Intervention Type: DRUG

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

Intervention Type: DEVICE

Interventions

Insulin dosing

Intervention Type: DRUG

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

Intervention Type: DEVICE

Other Intervention Names

Subjects will use their daily usual insulin: Lantus; Levemir; Humalog; Novorapid; Sensors: IR-Glucose Reader (Joanneum Research, Austria); IR-CGM (IMM, Germany)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas R Pieber, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University of Graz

Graz, Styria, Austria

Countries

Austria

Other Identifiers

REACTforSENSOR

Identifier Type: -

Identifier Source: org_study_id