Medical Devices: Evidence and Research (Sep 2020)
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
Abstract
Ripu Hundal,1 Stephan Kowalyk,2 Amanda Wakim,3 Carla Nikkel,4 John H Sink II,4 Melissa Doyle5 1First State Endocrinology, Newark, DE, USA; 2Endocrinology Specialists PC, Greensburg, PA, USA; 3Center of Endocrinology, Wheeling Hospital, Wheeling, WV, USA; 4Medical Affairs, Zealand Pharma, Boston, MA, USA; 5Progressive Diabetes Care, PLLC, Erwin, NC, USACorrespondence: Carla NikkelMedical Affairs, Zealand Pharma, 34 Farnsworth St, Floor 4, Boston, MA 02210, USATel +1 405-509-0401Fax +1 405-330-4040Email [email protected]: Patch-like wearable insulin delivery devices are gaining acceptance as a treatment modality for insulin delivery in patients with diabetes. These devices aim to simplify and optimize insulin delivery while reducing barriers associated with a basal-bolus insulin regimen. As clinicians aim to learn more about this method of insulin delivery, real-world evidence can provide insight for patient identification and treatment guidance. This study was performed to evaluate the change in glycemic control (A1C) and insulin total daily dose (TDD) after switching to V-Go wearable insulin delivery device in a type 2 diabetes population with suboptimal control using conventional insulin delivery regimens.Patients and Methods: Electronic health records were queried to identify patients meeting inclusion criteria. Study objectives evaluated change in A1C and insulin TDD compared to baseline. A total of 283 patients were enrolled across 9 diabetes specialty sites.Results: A1C significantly decreased from baseline at 3 months (− 1.01% ± 0.09; P=0.0001) and 7 months (− 1.04% ± 0.10; P< 0.0001) after switching to V-Go. TDD of insulin significantly decreased at 3 months (− 17 ± 3 U/day; P< 0.0001) and 7 months (− 14 ± 3 U/day; P< 0.0001). Stratifying by prescribed baseline insulin regimen (basal-bolus, basal only or premix) or diabetes duration (< 5 years to > 20 years) demonstrated significant glycemic improvements from baseline with V-Go regardless of baseline regimen or duration of diabetes. After 7 months of V-Go use, the percent of patients considered high risk (A1C > 9.0%) was reduced by nearly half (46% to 24%), and 52% of patients overall achieved an A1C < 8%.Conclusion: This study represents the largest real-world study of the effectiveness of V-Go in patients with type 2 diabetes. Significant improvements in glycemic control with a reduction in insulin utilization were achieved across varying baseline insulin regimens and regardless of diabetes duration supporting the clinical benefits of this patch-like wearable insulin delivery device.Keywords: basal-bolus, insulin, insulin delivery device, patch, type 2 diabetes, V-Go
