An in silico method to identify computer-based protocols worthy of clinical study: An insulin infusion protocol use case

Abstract

Preclinical in silico comparison analytical framework allows rapid and inexpensive identification of computer-based protocol care strategies that justify expensive and burdensome clinical trials.

A Methodology to Compare Insulin Dosing Recommendations in Real-Life Settings

“…One of the main differences between this study and others that retrospectively evaluated the performance of prandial insulin dosing recommendations is the source of the clinical data. For instance, previous studies have compared the effectiveness of insulin dosing recommendations in controlled environments such as in the ICU, 13,25 where glucose control is closely monitored and tracked and lifestyle behaviors are not a factor. In contrast, this study focused on free-living outpatients who made their own choices about insulin therapy, and where individual lifestyle choices have the potential to impact treatment decisions and outcomes.…”

“…The “appropriateness” of an IB was defined as one that brings the postprandial glucose to the desired target. 13 The method assumes that a conventional insulin dosing calculator, BCa (ie, IPBC or the participant), has made an IB recommendation. The point in time when BCa made the IB suggestion and when the insulin was delivered is referred to as the initial time, t i .…”

“…To evaluate the performance of the PDA against conventional approaches to prandial insulin dosing, the authors adapted methodology from Wong et al 13 For this study, the conventional approaches to insulin dosing were defined as either use of the IPBC or participant's self-determined doses. The PDA's recommendations were compared against those made by the participant's IPBC, or against the participant when they either overrode or neglected to get advice from their IPBC ( Figure 2).…”

“…7-12 Recently, Wong et al proposed a method to retrospectively compare insulin bolus (IB) recommendations using Intensive Care Unit (ICU) data. 13 They concluded that in silico comparisons appear to be an efficient nonclinical method for allowing rapid and inexpensive identification of computer-based protocols that justify expensive and burdensome clinical trials.…”

Liberal glucose targets for critically ill diabetic patients: is it time for large clinical trials with more personalized endpoints?

“…While the notion of using different glucose targets for different patient populations is daunting, future protocols may need that type of personalization to achieve desired outcomes. Computerized protocols with increasing sophistication have been developed and can be used to manage the many variables that influence glycemic control for future clinical trials (13).…”