Integrated blood glucose monitoring with insulin pumps versus standard method - a randomised crossover trial
Not Applicable
- Conditions
- Type 1 diabetes mellitusMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12611000142932
- Lead Sponsor
- Murdoch Children's Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Users due a pump upgrade within next 13 to 24 months
Exclusion Criteria
1) Have previously experienced significant skin reactions to pump giving sets, or other reactions which may mean that changing to a different pump may result in similar reaction and/or study withdrawal
2) Non-English speaking users
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Number of finger-prick blood glucose measurements entered into and recorded in participants' pump[6 months and 12 months (after each phase of trial)]
- Secondary Outcome Measures
Name Time Method Metabolic control as measured by HbA1c[3, 6, 9 and 12 months];User device satisfaction as measured by the Insulin Delivery System Rating Questionnaire (IDSRQ)[6 and 12 months];Information available to download from pump:<br>-total daily insulin dose<br>-number of boluses and percentage of dose given as a correction factor<br>-number of carbohydrate entries<br>-blood glucose variability<br>-% of insulin delivered as basal versus bolus<br>-% of blood glucose measurements within target range[3, 6, 9 and 12 months<br>Also assessed at 6 weeks after starting a new phase for assessment of novelty or carryover effect];Frequency of participants' contacts with the support team[6 and 12 months]