Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/02/2007
Date assigned
08/02/2007
Last edited
21/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J Hermanides

ORCID ID

Contact details

Academic Medical Centre
Department of Internal Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 8136
j.hermanides@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

The Eurythmics Trial

Study hypothesis

HbA1c can improve in type one diabetes patients who continuously use the Paradigm® REAL-Time system.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2007

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

104

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

Trial participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Internal Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Industry

Funder name

Medtronic B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21294770

Publication citations

  1. Results

    Hermanides J, Nørgaard K, Bruttomesso D, Mathieu C, Frid A, Dayan CM, Diem P, Fermon C, Wentholt IM, Hoekstra JB, DeVries JH, Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial., Diabet. Med., 2011, 28, 10, 1158-1167, doi: 10.1111/j.1464-5491.2011.03256.x.

Additional files

Editorial Notes