| - candidate number | 2429 |
| - NTR Number | NTR863 |
| - ISRCTN | ISRCTN22472013 |
| - Date ISRCTN created | 8-feb-2007 |
| - date ISRCTN requested | 7-feb-2007 |
| - Date Registered NTR | 24-jan-2007 |
| - Secondary IDs | N/A |
| - Public Title | Randomized, controlled, multinational, multi-center, clinical trial to examine whether HbA1c can improve in type 1 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 | Randomized, controlled, multinational, multi-center, clinical trial to examine whether HbA1c can improve in type 1 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). |
| - ACRONYM | The Eurythmics Trial |
| - hypothesis | HbA1c can improve in type 1 diabetes patients who continuously use the Paradigm® REAL-Time system. |
| - Healt Condition(s) or Problem(s) studied | Diabetes Mellitus Type 1 (DM type I) |
| - Inclusion criteria | 1. 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 ¡Ý 8.2% |
| - 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 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 received | no |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | [default] |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-feb-2007 |
| - planned closingdate | 31-dec-2007 |
| - 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 hyperglycemia, an insulin pump and a Bolus Wizard® calculator |
| - Primary outcome | HbA1c. |
| - Secondary outcome | 1. Hypoglycemie; 2. Hyperglycemie; 3. Quality of Life; 4. Contact tijd met onderzoeker. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | J. Hermanides |
| - CONTACT for SCIENTIFIC QUERIES | Dr. J.H. Vries, de |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Internal Medicine |
| - Funding (Source(s) of Monetary or Material Support) | Medtronic BV. |
| - Publications | N/A |
| - Brief summary | N/A |
| - Main changes (audit trail) | |
| - RECORD | 24-jan-2007 - 18-jan-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl