The aim of this study was to evaluate the impact on clinical parameters when using an innovative 24-hour wearable basal-bolus insulin delivery device (V-Go) for insulin delivery.
This real-world retrospective analysis utilized electronic health records from a large specialized diabetes center to identify patients exceeding glycemic targets (A1C > 7.0) prescribed basal-bolus MDI insulin (Basal-bolus MDI), basal insulin (Basal), premix insulin (Premix) or naïve to insulin (Insulin Naïve) at baseline, changed to V-Go between January 2013 and December 2016. Change in A1C, insulin total daily dose (TDD), concomitant non-insulin glucose lowering medications (NIGLM), reported hypoglycemia and weight were evaluated.
Results : Patients (N=139) met predetermined eligibility with mean baselines of age 60 yrs, weight 103 kg, BMI 35.0 kg/m2, A1C 9.7%, and diabetes duration 14 yrs. Hypoglycemia documented in 28% of patients. Prior to initiating V-Go, patients were prescribed Basal-bolus MDI (n=36, A1C 9.9%), Basal (n=73, A1C 9.6%), Premix (n=13, A1C 8.9%) and Insulin Naïve (n=17, A1C 11.1%) with 87% of all patients prescribed NIGLM. Changes in clinical parameters were evaluated after a mean V-Go exposure of 5 months. Reductions in A1C were observed across all patients and cohorts. Mean ± SD A1C changes from baseline were: all patients -1.5 ± 1.8%; p<0.0001, and cohorts Basal-bolus MDI -1.5 ± 2.0%; p<0.0001, Basal -1.3 ± 1.6%; p<0.0001, Premix -0.6 ± 1.5%; p=0.162 and Insulin Naïve -3.3 ± 1.3%; p<0.0001, respectively. Insulin TDD was decreased from 63 to 54 U/day; p=0.006 across all patients previously prescribed insulin with the greatest reduction (30%) in patients prescribed Basal-bolus MDI therapy (80 to 56 U/day; p<0.0001) prior. Percent of patients prescribed NIGLM decreased to 83% and documented hypoglycemia decreased to 25%. Mean weight change from baseline was + 0.91 kg; p=0.011 across all patients and + 0.68; p=0.074 in patients previously prescribed insulin.
Regardless of baseline regimen, use of V-Go provided clinical benefit. Significant improvement in glycemic control was observed with lower insulin requirements and less documented hypoglycemia compared to baseline. Innovative insulin delivery options provide effective and simplified approaches to deliver basal-bolus therapy and should be considered for patients requiring insulin.
V-Go is both safe and effective in patients with type 2 diabetes requiring basal-bolus therapy.
Premier Physician Network, Bull Family Diabetes Center
Trisha Zeidan, MD graduated from The Ohio State University College of Medicine and Public Health. She completed her internship, residency and fellowship at OSU. Dr. Zeidan's fellowship training was in endocrinology. She is board certified in both internal medicine and endocrinology. Dr. Zeidan currently practices at the Bull Family Diabetes Center in Dayton, Ohio. She practices compassionate, focused, and personalized diabetes care.
With the goal of reduction of diabetes and cardiovascular risks, she strives to enhance the self-management skills that patients need to overcome diabetes.
Senior Director, Medical Affairs
Carla Nikkel, RD, LD, CDE, CDTC is based out of Oklahoma and currently serves as the Senior Director of Medical Affairs for Valeritas, Inc. where she is responsible for the company’s Clinical Research Department, Medical Information Department and both the Clinical Education and Medical Science Liaison field teams. Carla earned her degree from Oklahoma State University and completed her internship at Baylor Medical Center, Dallas, Texas. She has presented research findings at national and international scientific meetings and has co-authored multiple manuscripts involving therapeutic options for the treatment of diabetes. Previously, Carla founded the largest comprehensive nutrition center in Oklahoma specializing in diabetes self-management, weight management and cardio-metabolic disease education.
Manager, Medical Affairs
Beth Dziengelewski, MS, RD, LD, CDE is based out of Central Ohio and her experience includes nearly 2 decades in the field of diabetes. She currently serves as Manager, Medical Affairs for Valeritas were she oversees clinical research projects and the dissemination of data by the medical information department. She has lead clinical education teams in prior roles in support of both injectable and inhaled insulin products, as well as an injectable CV product. Beth previously worked at The Ohio State University Medical Center Division of Endocrinology as a Senior Clinical Research Coordinator where she served as the site study manager for the ACCORD trial