SWITCH - Sensing With Insulin pump Therapy to Control HbA1c
- Conditions
- Type 1 diabetes mellitusNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN09806152
- Lead Sponsor
- Medtronic International Trading Sarl (Switzerland)
- Brief Summary
2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22965294 [added 28/02/2019]
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c, measured at baseline, midway and at the end of each arm.
- Secondary Outcome Measures
Name Time Method <br> 1. Change in glycaemic variability<br> 2. Change in occurrence of hypoglycaemia, measured throughout the study duration (approximately 16 months per patient)<br> 3. Time spent in euglycaemia<br> 4. Change in postprandial glycaemia<br> 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<br> 6. Severe hypoglycaemia or diabetic ketoacidosis (DKA) events, measured throughout the study duration (approximately 16 months per patient)<br>