Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/12/2007
Date assigned
23/01/2008
Last edited
20/09/2010
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 Tadej Battelino

ORCID ID

Contact details

University Children's Hospital
Vrazov trg 1
Ljubljana
SI-1525
Slovenia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00598663

Protocol/serial number

EUR03

Study information

Scientific title

Randomised, cross-over, controlled, multi-centric study to assess whether type 1 diabetic patients in sub-optimal glycaemic control can improve using the continuous glucose values of the MiniMed Paradigm REAL-Time Insulin Pump system versus the MiniMed Paradigm Insulin Pump

Acronym

SWITCH

Study hypothesis

Null hypothesis: There is a 0% reduction in HbA1c from baseline compared to control group, after 6 months of treatment.

As of 20/09/2010 this record was updated to include an extended trial end date; the initial end date at the time of registration was 01/01/2010. Please also note that the database was locked on 17/09/2010.

Ethics approval

Ethics approval received from the Ljubljana Clinical Centre, Institute for Neurophysiology (Inštitut za klinicno nevrofiziologijo, Klinicni center Ljubljana, Zaloška 7,1525 Ljubljana) (Slovenia) in December 2007.

Study design

Randomised controlled two-arm cross-over multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 1 diabetes mellitus

Intervention

Treatment: Insulin pump with continuous glucose sensing
Control: Insulin pump with self-monitoring blood glucose

There are 2 x arms of 6 months (crossover) and a washout period between the arms of 4 months (i.e. 6 months of first treatment regimen followed by a 4-month washout, then crossed over to the other treatment for 6 months).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

HbA1c, measured at baseline, midway and at the end of each arm.

Secondary outcome measures

1. Change in glycaemic variability
2. Change in occurrence of hypoglycaemia, measured throughout the study duration (approximately 16 months per patient)
3. Time spent in euglycaemia
4. Change in postprandial glycaemia
5. Quality of life (paediatrics) and treatment satisfaction (adults), assessed by the paediatric quality of life inventory (PedsQL) and the diabetes treatment satisfaction questionnaires (DTSQs), respectively, at baseline and end of each arm
6. Severe hypoglycaemia or diabetic ketoacidosis (DKA) events, measured throughout the study duration (approximately 16 months per patient)

Overall trial start date

01/01/2008

Overall trial end date

01/07/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent
2. Patients aged 6 years to 70 years old, both male and female
3. Sub-optimal glycaemic control (7.5% less than HbA1c less than 9.5%)
4. Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent
5. Patient treated within the practice of the investigator's centre at least 6 months prior to signature of informed consent
6. Patient has no preliminary experience with the sensor function of the Paradigm Real-Time (PRT)® or the Guardian® REAL-Time for the 4 months prior signature of informed consent

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Existing pregnancy or intention to conceive (as assessed by investigator)
2. Hearing or vision impairment so that glucose display and alarms cannot be recognised
3. Three or more incidents in the last 12 months of severe hypoglycaemia with documented blood glucose (BG) below 50 mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar
4. History of hypoglycaemic unawareness as assessed by the investigator
5. Alcohol or drug abuse, other than nicotine
6. Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema, etc.)
7. Any documented concomitant chronic disease known to affect diabetes control (e.g., altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Addison's disease) or any concomitant pharmacological treatment that might modify glycaemic values (e.g., chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults: body mass index (BMI) greater than 35 and children BMI greater than 2 s.d. for age) as assessed by the investigator
8. Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures
9. For paediatric subjects: does not have a reliable support person
10. Plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (e.g., exotic countries, remote places)
11. Participation in another clinical study, ongoing or completed less than 3 months prior to signature of patient informed consent

Recruitment start date

01/01/2008

Recruitment end date

01/07/2010

Locations

Countries of recruitment

Austria, Denmark, Italy, Luxembourg, Netherlands, Slovenia, Spain

Trial participating centre

University Children's Hospital
Ljubljana
SI-1525
Slovenia

Sponsor information

Organisation

Medtronic International Trading Sarl (Switzerland)

Sponsor details

Route Molliau
31
Tolochenaz
1131
Switzerland
+41 (0)21 802 7614
hannah.gough@medtronic.com

Sponsor type

Industry

Website

http://www.medtronic.com/

Funders

Funder type

Industry

Funder name

Medtronic International Trading Sarl (Switzerland)

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

Publication citations

Additional files

Editorial Notes