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:Achieving optimal glycemic control for many people with type1 diabetes (T1D) remains challenging even with the advent of newer managementtools, including continuous glucose monitoring (CGM). Management of T1D generatesa 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 patientsusing multiple daily injections (MDI).Research design and method:The studied DSS included real-time dosing advice and retrospectivetherapy optimization. Adults and adolescents (>15yo) with T1D using MDI wereenrolled at three sites in a 14-weeks randomized control trial of MDI+CGM+DSSvs. MDI+CGM. All participants (n=80), used degludec basal insulin and a DexcomG5 CGM. CGM-based and patient reported outcomes are analyzed. Within the DSSgroup, ad-hoc analysis further contrasted Active vs Non-active DSS users.Results:No significant differences were detected between experimentaland control groups (e.g. time in range CGM: +3.3% vs DSS: +4.4%). Participants inboth groups reported lower HbA1c (-0.3%, p=0.001) with respect to baseline.While TIR may have improved in both groups, it was statistically significantonly for DSS; the same was apparent for time<60. Active vs Non-active DSS usersshowed lower risk and exposure to hypoglycemia with system use.Conclusions:Our DSS system appears to be a feasible option for people onMDI, though the glycemic benefits associated with use need to be furtherinvestigated. System design, therapy requirements, and target population shouldbe further refined prior to use in clinical care.