NCT02155023

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

February 7, 2014

Last Update Submit

March 25, 2015

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • evaluate necessary run-in procedures by assessment of error over time

    12 hours

Other Outcomes (2)

  • Distribution of the glucose values

    12 hours

  • Malfunction of the systems

    12 hours

Study Arms (1)

Insulin dosing and glucose sensors

EXPERIMENTAL

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

Interventions

Insulin dosingDRUG
Also known as: Subjects will use their daily usual insulin:, Lantus, Levemir, Humalog, Novorapid, Sensors:, IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)
Insulin dosing and glucose sensors
Glucose sensors IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)DEVICE
Insulin dosing and glucose sensors

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin GlargineInsulin DetemirInsulin LisproInsulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-Acting

Study Officials

  • Thomas R Pieber, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

June 4, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

AU(1)