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.
Ethics approval
Ethics approval received from the Ljubljana Clinical Centre, Institute for Neurophysiology (Intitut za klinicno nevrofiziologijo, Klinicni center Ljubljana, Zaloka 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 cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details 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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22965294 [added 28/02/2019]