A Pragmatic Clinical Trial to Compare the Real-World Effectiveness of V-Go versus Standard Delivery of Insulin in Patients with Advanced Type 2 Diabetes

Abstract

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 realworld, 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.

Effectiveness of V-Go® for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study

“…Patient impressions of V-Go were generally high across all questions surveyed in this study, which is consistent with previous treatment satisfaction surveys [9,16]. V-Go ease of use compared to previous therapy received the highest rating (8.7 out of 10), which is significant considering that regimen complexity and patient satisfaction can both impact patient compliance, which is critical to improving glycemic control [19].…”

“…Cziraky and colleagues reported findings from a randomized controlled trial comparing V-Go to standard treatment optimization (STO). In this study, both therapies significantly reduced HbA1c from baseline V-Go (− 1.0%, P < 0.001) and STO (− 0.5%, P < 0.001); however, V-Go resulted in a significantly (P = 0.002) larger reduction [16].…”

“…These patch-like devices are now included in the American Diabetes Association's current clinical practice recommendations as an alternative to insulin pens and syringes, but prospective data evaluating the use of these devices in a real-world practice setting are limited. To our knowledge, only two prospective studies [16,17] have been published, and both are based on short-term use. This observational study, designed to mimic real-world conditions as closely as possible, explored the effectiveness and safety of V-Go use in patients with suboptimally controlled T2D.…”

“…Patients have reported the V-Go device to be discreet and easy to use, and the basal and bolus capability of the device eliminates the need for multiple injections, all of which may help improve patient compliance with insulin therapy [8,9]. Evidence has supported an improvement in glycemic control with V-Go [9][10][11][12][13][14][15][16][17]; however, prospective data are lacking, and further evidence is warranted to understand the impact of V-Go across a wide range of patients.…”

<p>Multicenter Real-World Assessment of the Effectiveness of V-Go Wearable Insulin Delivery Device in Adult Patients with Type 2 Diabetes (ENABLE Study): A Retrospective Analysis</p>

“…Previous studies showed that switching patients from traditional insulin delivery modes (insulin pens or syringes) to V-Go was associated with significantly improved glycemic control. 7,[11][12][13][14][15][16][17][18][19] This retrospective study represents the largest RWE study to date evaluating the use of V-Go across multiple practices. The objective of the study was to evaluate clinical outcomes in patients with sub-optimally controlled diabetes transitioned from other traditional modes of insulin delivery to V-Go.…”