Abstract
Many patients with type 2 diabetes mellitus (T2DM) do not have adequate glycemic control, leading to poor patient outcomes and high healthcare costs. 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. 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). 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) ...Continue Reading
References
Jun 8, 1999·JAMA : the Journal of the American Medical Association·R C TurnerR R Holman
May 23, 2007·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Meryl BrodDonald Bushnell
Sep 11, 2009·Health and Quality of Life Outcomes·Meryl BrodDonald M Bushnell
Jan 1, 2008·Journal of Diabetes Science and Technology·Christoph KapitzaPoul Strange
Mar 23, 2011·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Meryl BrodDonald M Bushnell
Jan 27, 2012·Diabetes Care·Gregory A NicholsKimberly G Brodovicz
May 3, 2012·Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·Cheryl R RosenfeldPoul Strange
Jan 18, 2013·Diabetic Medicine : a Journal of the British Diabetic Association·M J DaviesR Hughes
Oct 8, 2013·ClinicoEconomics and Outcomes Research : CEOR·Michael GrabnerRalph Quimbo
May 31, 2014·Journal of Diabetes Science and Technology·Barry R JohnsCatherine E Cooke
Mar 17, 2015·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Rajeev AyyagariEric Q Wu
Apr 24, 2015·Journal of Diabetes Science and Technology·Abigail WinterEmily Knezevich
Aug 25, 2015·Diabetes Spectrum : a Publication of the American Diabetes Association·P Gaye KnutsenCarla C Nikkel
Oct 17, 2015·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Rosemarie LajaraCarla Nikkel
Nov 14, 2015·Advances in Therapy·S Lane SlabaughD Chad Moretz
Feb 13, 2016·Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·Rosemarie LajaraTracy L Morris
Jul 12, 2016·Drugs -- Real World Outcomes·Rosemarie LajaraScott Abbott
Sep 13, 2016·Diabetes Research and Clinical Practice·Mehul R DalalNella Bieszk
Oct 22, 2016·Clinical Diabetes : a Publication of the American Diabetes Association·David SuttonScott Abbott
Jan 17, 2017·Journal of Gerontological Nursing·Alan BooninScott Abbott
Jun 24, 2017·Diabetes Care·David P Sonne, Bianca Hemmingsen
Citations
Dec 14, 2019·Drugs -- Real World Outcomes·George GrunbergerPoul Strange
Jul 7, 2019·Journal of Managed Care & Specialty Pharmacy·Amit D RavalRalph Quimbo
Sep 27, 2019·Journal of Managed Care & Specialty Pharmacy·Amit D RavalRalph Quimbo
Nov 19, 2020·Pharmacy : Journal of Pharmacy, Education and Practice·Trisha ZeidanAleda M H Chen
Nov 21, 2020·BMJ Open Diabetes Research & Care·Pablo F MoraBeverley Adams-Huet
Oct 17, 2020·Medical Devices : Evidence and Research·Ripu HundalMelissa Doyle
Oct 17, 2021·Journal of Diabetes Science and Technology·Carlos R VallarinoEric S Meadows