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
Scientific
University Children's Hospital
Vrazov trg 1
Ljubljana
SI-1525
Slovenia
Study information
| Study design | Randomised controlled two-arm cross-over multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | SWITCH |
| Study objectives | Null 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 (Intitut za klinicno nevrofiziologijo, Klinicni center Ljubljana, Zaloka 7,1525 Ljubljana) (Slovenia) in December 2007. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2008 |
| Completion date | 01/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 160 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 01/07/2010 |
Locations
Countries of recruitment
- Austria
- Denmark
- Italy
- Luxembourg
- Netherlands
- Slovenia
- Spain
Study participating centre
University Children's Hospital
Ljubljana
SI-1525
Slovenia
SI-1525
Slovenia
Sponsor information
Medtronic International Trading Sarl (Switzerland)
Industry
Industry
Route Molliau, 31
Tolochenaz
1131
Switzerland
| Phone | +41 (0)21 802 7614 |
|---|---|
| hannah.gough@medtronic.com | |
| Website | http://www.medtronic.com/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
