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).

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR863
• Date of registration: 24/01/2007
• Primary sponsor: Academic Medical Center (AMC), Department of Internal Medicine
• 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). - The Eurythmics Trial
• Date of first enrolment: 1/2/2007
• Target sample size: 104
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=863
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: [default]; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: J.H. Vries, de

• Name: J. Hermanides

Key inclusion & exclusion criteria

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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Diabetes Mellitus Type 1 (DM type I)

Intervention(s)

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(s)

HbA1c.

Secondary Outcome(s)

1. Hypoglycemie;

2. Hyperglycemie;

3. Quality of Life;

4. Contact tijd met onderzoeker.

Secondary ID(s)

ISRCTN22472013

N/A

Source(s) of Monetary Support

Medtronic BV.