Abstract
BackgroundPeople with T1DM and insulin-treated T2DM often do not follow and/or adjust their insulin regimens as needed. Key contributors to treatment non-adherence are fear of hypoglycaemia, difficulty and lack of self-efficacy associated with insulin dose determination. Because manual calculation of insulin boluses is both complex and time consuming, people may rely on empirical estimates, which can result in persistent hypoglycaemia and/or hyperglycaemia. Use of automated bolus advisors (BA) has been shown to help insulin pump users to more accurately meet prandial insulin dosage requirements, improve postprandial glycaemic excursions, and achieve optimal glycaemic control with an increased time within optimal range. Use of a BA containing an early algorithm based on sliding scales for insulin dosing has also been shown to improve HbA1c levels in people treated with multiple daily insulin injections (MDI). We designed a study to determine if use of an automated BA can improve clinical and psychosocial outcomes in people treated with MDI.Methods/designThe Automated Bolus Advisor Control and Usability Study (ABACUS) is a 6-month, prospective, randomised, multi-centre, multi-national trial to determine if automated BA use improves glycaemic control as measured by a change in HbA1c in people using MDI with elevated HbA1c levels (#62;7.5%). A total of 226 T1DM and T2DM participants will be recruited. Anticipated attrition of 20% will yield a sample size of 90 participants, which will provide #62;80% power to detect a mean difference of 0.5%, with SD of 0.9%, using a one-sided 5% t-test, with 5% significance level. Other measures of glycaemic control, self-care behaviours and psychosocial issues will also be assessed.DiscussionIt is critical that healthcare providers utilise available technologies that both facilitate effective glucose management and address concerns about safety and lifestyle. Automated BAs may help people using MDI to manage their diabetes more effectively and minimise the risk of long-term diabetes related complications. Findings from a recent study suggest that BA use positively addresses both safety and lifestyle concerns; however, randomised trials are needed to confirm these perceptions and determine whether bolus advisor use improves clinical outcomes. Our study is designed to make these assessments.Trial registrationNCT01460446
Highlights
People with Type 1 diabetes (T1DM) and insulin-treated Type 2 diabetes (T2DM) often do not follow and/or adjust their insulin regimens as needed
Findings from a recent study suggest that bolus advisors (BA) use positively addresses both safety and lifestyle concerns; randomised trials are needed to confirm these perceptions and determine whether bolus advisor use improves clinical outcomes
Because manual calculation of insulin boluses is both complex and time consuming, people may rely on empirical estimates, which can result in persistent hypoglycaemia and/or hyperglycaemia [16,17]
Summary
Optimal diabetes management is not achieved by many people with T1DM or insulin-treated T2DM who do not adjust their insulin regimens as needed [6,7,8,9] This can lead to poor metabolic control and subsequent poor health outcomes [14]. Studies have shown that use of automated bolus advisor technology among insulin pump users facilitates accurate determination of prandial insulin dosages, reduces postprandial excursion, and reduces hypoglycaemia, leading to improved glycaemic control [18,19]. Our study is designed to assess the impact of automated bolus advisor use on glycaemic control, user adherence, self-care behaviours, treatment satisfaction, social functioning and factors important to quality of life. Competing interests Funding for the study and preparation of the manuscript was provided by Roche Diagnostics, Indianapolis, Indiana, USA.
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