Impact of a Novel Diabetes Support System on a Cohort of Individuals With Type 1 Diabetes Treated With Multiple Daily Injections: A Multicenter Randomized Study

Objective: <p>Achieving optimal glycemic control for many people with type 1 diabetes (T1D) remains challenging even with the advent of newer management tools, including continuous glucose monitoring (CGM). Management of T1D generates a wealth of data; however, its use to optimize glycemic control remains limited. We evaluate the impact of a CGM-based decision support systems (DSS) in T1D patients using multiple daily injections (MDI).</p> <p>Research design and method:</p> <p>The studied DSS included real-time dosing advice and retrospective therapy optimization. Adults and adolescents (>15yo) with T1D using MDI were enrolled at three sites in a 14-weeks randomized control trial of MDI+CGM+DSS vs. MDI+CGM. All participants (n=80), used degludec basal insulin and a Dexcom G5 CGM. CGM-based and patient reported outcomes are analyzed. Within the DSS group, ad-hoc analysis further contrasted Active vs Non-active DSS users.</p> <p>Results:</p> <p>No significant differences were detected between experimental and control groups (e.g. time in range CGM: +3.3% vs DSS: +4.4%). Participants in both groups reported lower HbA1c (-0.3%, p=0.001) with respect to baseline. While TIR may have improved in both groups, it was statistically significant only for DSS; the same was apparent for time<60. Active vs Non-active DSS users showed lower risk and exposure to hypoglycemia with system use.</p> <p>Conclusions:</p> <p>Our DSS system appears to be a feasible option for people on MDI, though the glycemic benefits associated with use need to be further investigated. System design, therapy requirements, and target population should be further refined prior to use in clinical care.</p>