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Randomized, controlled, multinational, multi-center, clinical trial to examine whether HbA1c can improve in type 1 diabetes patients who continuously use the ParadigmŽ 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 (GuardianŽ REAL-Time Clinical).


- candidate number2429
- NTR NumberNTR863
- ISRCTNISRCTN22472013
- Date ISRCTN created8-feb-2007
- date ISRCTN requested7-feb-2007
- Date Registered NTR24-jan-2007
- Secondary IDsN/A 
- Public TitleRandomized, controlled, multinational, multi-center, clinical trial to examine whether HbA1c can improve in type 1 diabetes patients who continuously use the ParadigmŽ 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 (GuardianŽ REAL-Time Clinical).
- Scientific TitleRandomized, controlled, multinational, multi-center, clinical trial to examine whether HbA1c can improve in type 1 diabetes patients who continuously use the ParadigmŽ 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 (GuardianŽ REAL-Time Clinical).
- ACRONYMThe Eurythmics Trial
- hypothesisHbA1c can improve in type 1 diabetes patients who continuously use the ParadigmŽ REAL-Time system.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 1 (DM type I)
- Inclusion criteria1. Patients have been diagnosed with type 1 diabetes at least 12 months prior to study entry;
2. Patients are between 18 and 65 years of age, inclusive;
3. Patients are on multiple injection treatment, defined as a basal insulin analogue qd or bid and a rapid-acting insulin analogue used with every meal OR Patients are on conventional MIT in whom previous treatment with long- and rapid-acting insulin has failed;
4. Patients are on multiple injection treatment at least 3 months prior to inclusion;
5. Patients have a baseline HbA1c ĄŨ 8.2%
- Exclusion criteria1. 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 CSII in the last six months prior to entry in the study;
6. Patients suffering from Cancer, Heart Failure, kidney disease (creatinin > 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 1 and Visit 2;
9. Patient has planned trips when he/she will be out of telephone reach from the study medical care for >5 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2007
- planned closingdate31-dec-2007
- Target number of participants104
- InterventionsUsing the ParadigmŽ REAL-Time device, consisting of a continuous subcutaneous glucose sensor, equipped with an alarm function for upcoming hypo- and hyperglycemia, an insulin pump and a Bolus WizardŽ calculator
- Primary outcomeHbA1c.
- Secondary outcome1. Hypoglycemie;
2. Hyperglycemie;
3. Quality of Life;
4. Contact tijd met onderzoeker.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES J. Hermanides
- CONTACT for SCIENTIFIC QUERIESDr. J.H. Vries, de
- Sponsor/Initiator Academic Medical Center (AMC), Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
Medtronic BV.
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD24-jan-2007 - 18-jan-2010


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