Low–Blood Glucose Avoidance Training Improves Glycemic Variability in Adults With Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia: HypoCOMPaSS Trial

2016 
The Comparison of Optimized MDI Versus Pumps With or Without Sensors in Severe Hypoglycemia (HypoCOMPaSS) trial was a prospective, multicenter, randomized controlled trial examining the restoration of impaired awareness of hypoglycemia (IAH) and the prevention of severe hypoglycemia (SH) in adults with type 1 diabetes using multiple daily injections (MDI) compared with continuous subcutaneous insulin infusion (CSII), with or without adjunctive real-time continuous glucose monitoring (RT-CGM), using a 2 × 2 factorial design (1). Few studies are currently available to compare the difference in glucose variability (GV) between MDI and CSII and between self-monitored blood glucose (SMBG) and RT-CGM (2–4). These studies showed an improvement in GV in favor of CSII and RT-CGM. However, none of them included participants with IAH or history of SH. The aim of this study is to compare the changes in GV between MDI and CSII and between SMBG and RT-CGM group in this specific patient group with type 1 diabetes with IAH or recurrent SH. A total of 96 participants were recruited for the study. Each participant undertook 7 days of blinded CGM using Medtronic iPro at baseline and prior to each of the four weekly visits during the 24-week randomized controlled trial period. GV was measured as glucose SD and coefficient of variation (%CV), calculated using available Excel formulas published online (5). Overall, there were decreases in GV between baseline and week …
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