None listed
Conditions
Brief summary
This project aims to test whether a new blood glucose monitoring system increases the number of tests that patients with type 1 diabetes do as compared with an existing blood glucose monitoring system. The project also aims to test whether the new blood glucose testing system improves diabetic control and improves how you feel about your diabetes. The project also aims to test whether the new blood glucose testing system is preferred by users over the existing system Many studies have demonstrated that regular self monitoring of blood glucose improved overall control in type 1 diabetes and that better control results in better long-term outcomes and fewer complications. There are many reasons why people with type 1 diabetes do not monitor optimally. These include forgetfulness, difficulties with handling and disposing of test strips, lifestyle alignment (embarrassment of monitoring in public and lack of time and difficulty monitoring away from home), as well as inability to make decisions based on results. The new blood glucose testing system addresses some of these issues and previous surveys have shown that compliance with a testing regime is improved. There has, however, not been a formal study of the system to date and this study hopes to fill that gap in medical knowledge. Fifty people with type 1 diabetes will be recruited from Eastern Health and Royal Prince Alfred diabetes clinics to participate in the study. Subjects will be randomized to receive either the existing or the new system to begin with and to use that system for 3 months. After that period subjects will swap to the alternate system for a further 3 months. At the end of 6 months subject will be able to chose which system they prefer to use for the remaining 3 months of the study which therefore has a total duration of 9 months. Subjects will be required to attend every 3 months during the study (total of 4 visits) at which time the content of the meters memory will be down loaded for analysis. Subject will also be asked to complete questionnaires relating to their mood, level of distress, attitude and satisfaction.
Interventions
Accu-chek Mobile (TM) system
The Mobile (TM) incorporates a number of features which eliminate the need to handle test strips or single lancets before and after use, giving the user more freedom and flexibility when monitoring blood glucose, as well as allowing more discrete monitoring. The Mobile(TM) also allows the user to set up to 10 reminder times – at each set time a beep sounds and the reminder time is displayed.
Participants will be randomized to use the Mobile(TM) or the comparator syst
Accu-chek Mobile (TM) system The Mobile (TM) incorporates a number of features which eliminate the need to handle test strips or single lancets before and after use, giving the user more freedom and flexibility when monitoring blood glucose, as well as allowing more discrete monitoring. The Mobile(TM) also allows the user to set up to 10 reminder times – at each set time a beep sounds and the reminder time is displayed. Participants will be randomized to use the Mobile(TM) or the comparator system (see below) 4 times daily for 3 months and then will cross over (without washout) to the alternative system for a futher 3 months. Participants will then be asked to use their preferred system exclusively for a futher 3 months (total duration 9 months).
Sponsors
Roche Diagnostics Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Type 1 diabetes diagnosed for greater than or equal to one year 2. Known to the study site (ie. attended for clinical care greater than or equal to 2 visits in the last 2 years) 3. Glycosylated haemoglobin (HbA1c) greater than or equal to 7.5 % 4. Aged 18-45 years 5. Their health care professional recommends that they monitor greater than or equal to 4 times a day 5. They are performing some monitoring but less than 21 blood glucose estimations per week 6. They are able to understand, read and write English without assistance 7. They are willing to attend for all of the scheduled study visits 8. They are prepared to use the two blood glucose monitoring systems being used in the study.
Exclusion criteria
1. Type 2 diabetes 2. Use of oral or inhaled steroids 3 They are pregnant or planning a pregnancy 4. They have an infection 5. medical condition, such as cancer, severe depression or other psychological conditions that, in the opinion of the investigators, makes the person unsuitable for inclusion in the study.
Outcome results
None listed