@article{6c75ec1268454b49a4f0b8513731a2f7,
title = "Comparing Patch vs Pen Bolus Insulin Delivery in Type 2 Diabetes Using Continuous Glucose Monitoring Metrics and Profiles",
abstract = "Objective: CeQur Simplicity{\texttrademark} (CeQur, Marlborough, MA) is a 3-day insulin delivery patch designed to meet mealtime insulin requirements. A recently reported 48-week, randomized, multicenter, interventional trial compared efficacy, safety and self-reported outcomes in 278 adults with type 2 diabetes (T2D) on basal insulin therapy who initiated and managed mealtime insulin therapy with a patch pump versus insulin pen. We assessed changes in key glycemic metrics among a subset of patients who wore a continuous glucose monitoring (CGM) device. Methods: Study participants (patch, n = 49; pen, n = 48) wore a CGM device in masked setting during the baseline period and prior to week 24. Glycemic control was assessed using international consensus guidelines for percentage of Time In Range (%TIR: >70% at 70-180 mg/dL), Time Below Range (%TBR: <4% at <70 mg/dL; <1% at <54 mg/dL), and Time Above Range (%TAR: <25% at >180 mg/dL; <5% at >250 mg/dL). Results: Both the patch and pen groups achieved recommended targets in %TIR (74.1% ± 18.7%, 75.2 ± 16.1%, respectively) and marked reductions in %TAR >180 mg/dL (21.1% ± 19.9%, 19.7% ± 17.5%, respectively) but with increased %TBR <70 mg/dL (4.7% ± 5.2%, 5.1 ± 5.8, respectively), all P <.0001. No significant between-group differences in glycemic improvements or adverse events were observed. Conclusions: CGM confirmed that the patch or pen can be used to safely initiate and optimize basal-bolus therapy using a simple insulin adjustment algorithm with SMBG. Preference data suggest that use of the patch vs pen may enhance treatment adherence.",
keywords = "CGM, SMBG, T2D, TIR, algorithm, mealtime insulin, patch, time in range, type 2 diabetes",
author = "Bergenstal, {Richard M.} and Johnson, {Mary L.} and Aroda, {Venita R.} and Brazg, {Ronald L.} and Dreon, {Darlene M.} and Frias, {Juan P.} and Kruger, {Davida F.} and Molitch, {Mark E.} and Mullen, {Deborah M.} and Mark Peyrot and Sara Richter and Julio Rosenstock and Pierre Serusclat and Carl Vance and Weinstock, {Ruth S.} and Levy, {Brian L.}",
note = "Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded by Calibra Medical (Wayne, PA), which has since been acquired by CeQur SA (Horw, Switzerland). Funding Information: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: RMB has received research support, consulted, or has been on a scientific advisory board for Abbott Diabetes Care, Ascensia, CeCur Corporation, DexCom, Hygieia, Insulet, Johnson & Johnson, Lilly, Medtronic, Novo Nordisk, Onduo, Roche, Sanofi and United Healthcare. His technology research is funded in part by NIH/NIDDK. RMB{\textquoteright}s employer, non-profit HealthPartners Institute, contracts for his services and no personal income goes to RMB. M.L.J. has received research support from or participated in clinical trials supported by Abbott, Dexcom, Johnson & Johnson, Hygieia, Medtronic, the NIDDK, and Novo Nordisk; her employer (the nonprofit Health Partners Institute) contracts for her services; no personal income goes to M.L.J. V.R.A. has had research contracts (clinical trials) within the past 12 months from AstraZeneca/BMS, Calibra Medical, Eisai, Elcelyx, Janssen, Novo Nordisk, Sanofi, and Theracos; and has provided consultant activities within the past 12 months for the ADA, Medscape, Novo Nordisk, Sanofi, and Tufts. R.L.B. (Rainier Clinical Research Center) has received research support from Abbott, Diasome, Eli Lilly and Company, Dexcom, Johnson & Johnson, Medtronic, Novartis, Novo Nordisk, Sanofi, and ViroMed. D.M.D. is a full-time employee of Calibra Medical. J.P.F. has received research support from AbbVie, Allergan, AstraZeneca, Boehringer Ingelheim, BMS, Elcelyx, Eli Lilly and Company, Genentech, IONIS, Janssen, Johnson & Johnson, Lexicon, Ligand, Madrigal, Merck, Mylan, Myovant, Novartis, Novo Nordisk, Ogeda, Pfizer, Sanofi, TaiwanJ, Theracos, and Viking; and is on advisory boards and a consultant for AstraZeneca, BMS, Echosens, Elcelyx, Johnson & Johnson, Ligand, Novo Nordisk, and Sanofi. D.F.K. has served on advisory boards and/or speaker bureaus for Abbott, AstraZeneca, Aventis, Boehringer Ingelheim, Eli Lilly and Company, Dexcom, Intarcia, Insulet, Janssen, Novo Nordisk, Sanofi, and Valeritas, and her institution has received research support from AstraZeneca, Eli Lilly and Company, Dexcom, Lexicon, and Novo Nordisk. M.E.M. has received research support from Janssen Pharmaceuticals, Bayer, Novartis, NovoNordisk, Strongbridge, Crinetics and consulted for Merck, Pfizer, Sanofi, Janssen. D.M.M.{\textquoteright}s nonprofit employer has received research grants from Abbott Diabetes Care and Dexcom for which there was no personal compensation. M.P. has received research support, has acted as a consultant, or has been on the scientific advisory board for Becton-Dickinson, CeQur Corporation, Eli Lilly and Company, Johnson & Johnson, Novo Nordisk, and Valeritas. S.R. has participated in other clinical trials sponsored by the Johnson & Johnson group; her employer contracts for her services and no personal income goes to her. J.R. has served on scientific advisory boards and received honorarium or consulting fees from Boehringer Ingelheim, Eli Lilly and Company, Intarcia, Janssen, Novo Nordisk, and Sanofi. He has received grants/research support from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Genentech, Intarcia, Janssen, Lexicon, Merck, Novo Nordisk, Pfizer, and Sanofi. P.S. has served on advisory boards for Novo Nordisk and has received research support from Eli Lilly and Company, Novo Nordisk, and Sanofi. C.D.V. has received research support from the following: Allergan, Ascensia, AstraZeneca, Boehringer Ingelheim, Glooko, Eli Lilly and Company, Mylan, Novo Nordisk, Oramed, Sanofi, Tolerion and vTv Therapeutics. He serves on no advisory boards. R.S.W. has received research support from or participated in clinical trials supported by Dexcom, Diasome Pharmaceuticals, the Harry B. Helmsley Charitable Trust, the JDRF, the Jaeb Center for Health Research/Leona M. and Medtronic, the Kowa Research Institute, Mylan GmbH, and the NIDDK. B.L.L. is a former full-time employee of LifeScan, Inc. and Calibra Medical and provides consulting services to CeQur Corporation. Publisher Copyright: {\textcopyright} 2021 Diabetes Technology Society.",
year = "2022",
month = sep,
doi = "10.1177/19322968211016513",
language = "English (US)",
journal = "Journal of Diabetes Science and Technology",
issn = "1932-2968",
publisher = "Diabetes Technology Society",
}
