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Randomised, controlled, multinational, multicentre, clinical trial to examine whether HbA1c can improve in type one diabetes patients who continuously use the Paradigm® REAL-Time system with alarm function as compared to patients on multiple injection therapy receiving one six-day period of continuous glucose monitoring - without alarm function (Guardian® REAL-Time Clinical)
ISRCTN ISRCTN22472013
DOI 10.1186/ISRCTN22472013
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised, controlled, multinational, multicentre, clinical trial to examine whether HbA1c can improve in type one diabetes patients who continuously use the Paradigm® REAL-Time system with alarm function as compared to patients on multiple injection therapy receiving one six-day period of continuous glucose monitoring - without alarm function (Guardian® REAL-Time Clinical)
Scientific title
Acronym The Eurythmics Trial
Serial number at source N/A
Study hypothesis HbA1c can improve in type one diabetes patients who continuously use the Paradigm® REAL-Time system.
Lay summary Not provided at time of registration
Ethics approval Approval received from the local ethics board (Medisch Ethische Commissie) on the 18th January 2007 (ref: MEC 06/302, ref of approval: 06-302 07.17.0102).
Study design Randomised, controlled, parallel group multicentre trial
Countries of recruitment Netherlands
Disease/condition/study domain Diabetes Mellitus Type one (DM type one)
Participants - inclusion criteria 1. Patients have been diagnosed with type one diabetes at least 12 months prior to study entry
2. Patients are between 18 and 65 years of age, inclusive
3. Patients are:
a. on Multiple Injection Treatment (MIT), defined as a basal insulin analogue once or twice a day and a rapid-acting insulin analogue used with every meal, or
b. on conventional MIT in whom previous treatment with long- and rapid-acting insulin has failed
4. Patients are on multiple injection treatment at least three months prior to inclusion
5. Patients have a baseline HbA1c of more than or equal to 8.2%
Participants - exclusion criteria 1. Patient has hearing problems or impaired vision that might hinder recognition of the sensor alarm or screen alarms, respectively
2. Alcohol or drug abuse other than nicotine
3. Abdominal abnormalities, like lipodystrophia that might hinder either glucose measurement by the sensor or the continuous subcutaneous insulin infusion
4. Current pharmaceutical treatment for any psychiatric disorder other than depression
5. Treatment with Continuous Subcutaneous Insulin Infusion (CSII) in the last six months prior to entry in the study
6. Patients suffering from cancer, heart failure, kidney disease (creatinine more than 150 micromol/l) and other chronic debilitating conditions
7. Patient is unwilling or unable to comply with the provisions of the protocol
8. Patient has scheduled a vacation which will occur between visit one and visit two
9. Patient has planned trips when he/she will be out of telephone reach from the study medical care for more than five days or to a place where he/she cannot comply with study procedures
10. Being pregnant, or the wish to become pregnant during the trial
11. Patient is participating in another device or drug study
Anticipated start date 01/02/2007
Anticipated end date 31/12/2007
Status of trial Completed
Patient information material
Target number of participants 104
Interventions Using the Paradigm® REAL-Time device, consisting of a continuous subcutaneous glucose sensor, equipped with an alarm function for upcoming hypo- and hyperglycaemia, an insulin pump and a Bolus Wizard® calculator, versus MIT.
Primary outcome measure(s) HbA1c levels.
Secondary outcome measure(s) 1. Hypoglycaemic
2. Hyperglycaemic
3. Quality of life
4. Time spent with the researcher during a visit (Contact tijd met onderzoeker)
Sources of funding Medtronic B.V. (The Netherlands)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21294770
Contact name Dr  J  Hermanides
  Address Academic Medical Centre
Department of Internal Medicine
P.O. Box 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Tel +31 (0)20 566 8136
  Fax +31 (0)20 691 4904
  Email j.hermanides@amc.uva.nl
Sponsor Academic Medical Centre (AMC) (The Netherlands)
  Address Department of Internal Medicine
P.O. Box 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Sponsor website: http://www.amc.uva.nl/
Date applied 08/02/2007
Last edited 21/12/2011
Date ISRCTN assigned 08/02/2007
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