SWITCH - Sensing With Insulin pump Therapy to Control HbA1c

ISRCTN ISRCTN09806152
DOI https://doi.org/10.1186/ISRCTN09806152
ClinicalTrials.gov number NCT00598663
Secondary identifying numbers EUR03
Submission date
05/12/2007
Registration date
23/01/2008
Last edited
28/02/2019
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 of protocol

Not provided at time of registration

Contact information

Dr Tadej Battelino
Scientific

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

Study information

Study designRandomised controlled two-arm cross-over multicentre trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleRandomised, 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
Study acronymSWITCH
Study objectivesNull hypothesis: There is a 0% reduction in HbA1c from baseline compared to control group, after 6 months of treatment.
Ethics approval(s)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.
Health condition(s) or problem(s) studiedType 1 diabetes mellitus
InterventionTreatment: 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 typeOther
Primary outcome measureHbA1c, measured at baseline, midway and at the end of each arm.
Secondary outcome measures1. 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 study start date01/01/2008
Completion date01/07/2010

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants160
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2008
Date of final enrolment01/07/2010

Locations

Countries of recruitment

  • Austria
  • Denmark
  • Italy
  • Luxembourg
  • Netherlands
  • Slovenia
  • Spain

Study participating centre

University Children's Hospital
Ljubljana
SI-1525
Slovenia

Sponsor information

Medtronic International Trading Sarl (Switzerland)
Industry

Route Molliau, 31
Tolochenaz
1131
Switzerland

Phone +41 (0)21 802 7614
Email hannah.gough@medtronic.com
Website http://www.medtronic.com/
ROR logo "ROR" https://ror.org/04pf17v09

Funders

Funder type

Industry

Medtronic International Trading Sarl (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2012 28/02/2019 Yes No

Editorial Notes

28/02/2019: Publication reference added.
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.