RESUMEN
BACKGROUND: Many patients with type 2 diabetes mellitus (T2DM) do not have adequate glycemic control, leading to poor patient outcomes and high healthcare costs. OBJECTIVE: This prospective pragmatic clinical trial evaluated V-Go, a wearable insulin delivery device, compared with standard treatment optimization (STO) among insulin-treated patients with T2DM in a real-world, community-based practice setting. METHODS: Study sites, rather than individual patients, were randomized to V-Go or STO via cluster randomization. Patients were treated according to routine clinical practice and followed up to 4 months. T2DM medications and supplies were purchased utilizing usual insurance and co-pay systems. The primary analysis was an unadjusted treatment group comparison of glycosylated hemoglobinA1c (HbA1c) change from baseline to end of study (EOS). A cost of therapy analysis was completed on patients who had received comparable baseline T2DM treatment with multiple daily basal-bolus insulin injections (MDI). RESULTS: Analysis included 415 patients (169 V-Go, 246 STO) enrolled from 52 US sites. Mean baseline HbA1c (9.6%) was higher in V-Go (9.9%, range 8.0% - 14.2%) than STO (9.3%, range 7.9% - 13.9%, p <.001). HbA1c decreased from baseline to EOS in both V-Go (-1.0%, p<.001) and STO (-0.5%, p<.001); V-Go had significantly larger decrease (p=.002). V-Go had a significant reduction (p<.001) in mean insulin total daily dose (TDD; 0.76 U/kg baseline, 0.57 U/kg EOS), not seen in STO (0.72 U/kg baseline and EOS). The MDI group included 95 (56.2%) V-Go and 113 STO (45.9%) patients. Mean baseline HbA1c was significantly higher in V-Go (9.9%) than STO (9.4%). V-Go also experienced larger decrease in HbA1c from baseline (-1.0%) than STO (-0.36%) (p=.006) with a decrease in TDD, while STO TDD remained unchanged. EOS mean per patient per day cost of diabetes treatment was lower for V-Go ($30.59) vs STO ($32.20) (p=.006). V-Go was more cost effective than STO ($24.02 per 1% drop in HbA1c vs $58.86, respectively). CONCLUSIONS: This pragmatic clinical trial demonstrated improved HbA1c levels, lower cost, and decreased insulin dose in patients with T2DM initiating V-Go vs STO in a real-world community-based practice setting. Observed baseline HbAlc indicated use of V-Go in more difficult to manage diabetes patients.
RESUMEN
OBJECTIVE: Insulin is one of the most efficacious treatments for hyperglycemia; however, adherence to insulin therapy is poor, impacting its efficacy. Thus, the objectives of this study were to determine if persistent use of a new insulin delivery option, V-Go, improved clinical outcomes and secondly compare clinical and economic outcomes between persistent use of V-Go and conventional insulin delivery (CID). METHODS: A retrospective review of an outpatient clinic's records was performed. Patients initiating V-Go with documented persistent use of V-Go or resumed persistent use of CID after short-term V-Go use were included (≥5 months of persistency). Baseline data and a total of two post-V-Go or CID initiation visits were examined for clinical and economic outcomes. Cost-effectiveness of each therapy was calculated by dividing the mean cost difference (baseline to office visit 2) by the mean change in A1c (baseline to office visit 2). RESULTS: V-Go persistent patients had a significant decrease in A1c (-1.42; pâ¯<â¯0.001). Between baseline and office visit two, they required less insulin units/day and units/kg and had significantly lower A1c, insulin units/day, insulin units/kg, and 30-day insulin costs than CID patients. V-Go persistent patients had a lower incremental cost by $695.61 per 1% change in A1c compared to CID persistent patients. CONCLUSIONS: Utilization of a new insulin delivery option resulted in improved clinical outcomes compared to CID and was more cost-effective. Clinicians and health plans should consider the use of new insulin delivery options for the management of patients with diabetes on insulin therapy to promote persistence.
