Safe and Efficacious Use of Automated Bolus Advisors in Individuals Treated With Multiple Daily Insulin Injection (MDI) Therapy

Abstract

A key challenge for many patients with diabetes who are treated with intensive insulin therapy is calculating accurate bolus insulin dosages.1,2 Bolus insulin calculation requires individuals to utilize several factors, including insulin-tocarbohydrate (I:CHO) ratios, insulin sensitivity factors (ISFs), target blood glucose (BG) range, current BG values, anticipated physical activity, and general health status. 3Making these calculations is especially problematic in individuals with deficits in literacy and numeracy, which are common in many societies and, thus, among individuals with diabetes. 4 Another obstacle is lack of competency in carbohydrate counting; several studies have shown that inaccuracy in carbohydrate counting is widespread among children and adults. 3,[5][6][7] Because these dosage calculations can be both complex and time-consuming, individuals often rely on empirical estimates of their insulin needs, which can limit their ability to achieve optimal glycemic control. 8Many current insulin pump systems feature bolus advisor capability, which automatically calculates insulin boluses to address carbohydrate intake and out-of-range BG levels. Use of an automated bolus advisor (BA) can address many of the obstacles associated with intensive insulin therapy by reducing the burden of intensive insulin regimens,increasing treatment satisfaction, 3,9,10 addressing deficits in numeracy and carbohydrate counting, 1,3,9,11 and improving glycemic outcomes. 8,12,13 However, because insulin pump use has not been widely adopted due to perceived complexity of insulin pumps and the extensive training required, 14,15 individuals treated with multiple daily insulin injections (MDIs) do not benefit from automated BA technology in their self-management regimens.Although a growing number of smartphone apps and devices with BA technology are in development, none of the apps are FDA-approved, and only 2 stand-alone devices with integrated BG monitoring capability are commercially AbstractNumerous studies have shown that use of integrated automated bolus advisors (BAs) provides significant benefits to individuals using insulin pump devices, including improved glycemic control and greater treatment satisfaction. Within the past few years, BA devices have been developed specifically for individuals treated with multiple daily insulin injection (MDI) therapy; however, many clinicians who treat these individuals may be unfamiliar with insulin pump therapy and, thus, BA use. Findings from the Automated Bolus Advisor Control and Usability Study (ABACUS) revealed that BA use can be efficacious and clinically meaningful in MDI therapy, and that most patients are willing and able to use this technology appropriately when adequate clinical support is provided. The purpose of this article is to review key learnings from ABACUS and provide practical advice for initiating BA use and monitoring therapy.

Bolus Calculator Reduces Hypoglycemia in the Short Term and Fear of Hypoglycemia in the Long Term in Subjects with Type 1 Diabetes (CBMDI Study)

“…The initial dropouts could be due to the disappointment for not having been included in the Cb group from the outset of the study, which concurs with the interpretation of the investigators in the ABACUS study. 9 There were no dropouts or withdrawals due to the difficulty of using the device, in fact, the participants considered the BC easy to learn and use, as can be seen in the scores of the questionnaires on the use of the BC.…”

Suboptimal behaviour and knowledge regarding overnight glycaemia in adults with type 1 diabetes is common

“…However, if the insulin sensitivity factor and insulin action duration are incorrect, this may not be so, and also, patients may not use the bolus calculator. Bolus advisors, such as in insulin pumps or ‘smart’ BG meters, can improve insulin dose choices and glycaemia . Lawton et al .…”

“…Bolus advisors, such as in insulin pumps or 'smart' BG meters, can improve insulin dose choices and glycaemia. 26,27 Lawton et al showed that whilst most T1D patients perceive this technology as having advantages, it also has disadvantages, such as dependence on the calculator, not remembering their insulincarbohydrate and insulin sensitivity factor(s) and that these settings can change over time. 28 Study strengths are novelty; clinical relevance; feasibility for clinical use; large sample size across two clinics and high participation rates; wide range of patient ages and diabetes duration and analyses by insulin delivery mode, IHA status and desire for education.…”

Unknown Safety and Efficacy of Smartphone Bolus Calculator Apps Puts Patients at Risk for Severe Adverse Outcomes

“…[21][22][23] Moreover, as with any new tool or technology, it is important that patients fully understand how to use their bolus calculator devices safely and effectively. Parkin and colleagues 24 recently published a list of key considerations for training and use of automated bolus calculator technology (Table 1). It should be noted, however, that the majority of these recommendations apply to all MDI-treated individuals regardless of automated bolus calculator use.…”

“…24 1. Determine patient competency in utilizing MDI therapy and self-management skills, such as carbohydrate counting/calorie counting, sick day management, and hypoglycemia treatment.…”