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 | https://doi.org/10.1186/ISRCTN22472013 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/02/2007
- Registration date
- 08/02/2007
- Last edited
- 21/12/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr J Hermanides
Scientific
Scientific
Academic Medical Centre
Department of Internal Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 8136 |
|---|---|
| j.hermanides@amc.uva.nl |
Study information
| Study design | Randomised, controlled, parallel group multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Diagnostic |
| Scientific title | |
| Study acronym | The Eurythmics Trial |
| Study hypothesis | HbA1c can improve in type one diabetes patients who continuously use the Paradigm® REAL-Time system. |
| Ethics approval(s) | 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). |
| Condition | Diabetes Mellitus Type one (DM type one) |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | HbA1c levels. |
| Secondary outcome measures | 1. Hypoglycaemic 2. Hyperglycaemic 3. Quality of life 4. Time spent with the researcher during a visit (Contact tijd met onderzoeker) |
| Overall study start date | 01/02/2007 |
| Overall study end date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 104 |
| Participant 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% |
| Participant 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 |
| Recruitment start date | 01/02/2007 |
| Recruitment end date | 31/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Internal Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Industry
Medtronic B.V. (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2011 | Yes | No |
