| Round Navigation, www.pngtree.com, By 588ku, retrieved Sep. 4, 2024, posted online Jun. 18, 2018 URL<:https://pngtree.com/freepng/round-navigation-icon_4752591.html (Year: 2018). |
| Dexcom, www.diabetesstrong.com, By Christel Oerum, MS, retrieved online Sep. 4, 2024, posted online Apr. 20, 2020 URL<:http://web.archive.org/web/20200420123603/https://diabetesstrong.com/dexcom-cgm-trend-arrows/ (Year: 2020). |
| Blue Circle, www.instagram.com, By bluecirclediabetesfoundation, retrieved Sep. 4, 2024, posted online Jan. 12, 2020 URL<:https://www.instagram.com/p/B7OINIHBIAD/?utm_source=ig_embed&utm_campaign=loading (Year: 2020). |
| AiDEX, www.appadvice.com, retrieved online Sep. 4, 2024, posted online Nov. 9, 2022 URL<:https://appadvice.com/app/wellion-aidex-sensor-mmol-l/6444144767 (Year: 2022). |
| Abbot press release (2020). “New late-breaking data show use of Abbott's Freestyle® Libre System significantly reduces HBA1C levels in people with type 2 diabetes using insulin or not,” 3 pages. |
| Al Hayek et al., “Patient Satisfaction and Clinical Efficacy of Novel Blood Glucose Meters Featuring Color Range Indicators in Patients With Type 2 Diabetes: A Prospective Study” Cureus Oct. 27, 2020; 12(10):e11195. 8 pages. doi:10.7759/cureus.11195. |
| Allen et al., “Continuous glucose monitoring counseling improves physical activity behaviors of individuals with type 2 diabetes: A randomized clinical trial” Diabetes Res Clin Pract. Jun. 2008; 80(3): 371-379. doi:10.1016/j.diabres.2008.01.006. |
| American Diabetes Association® Press Release (2020). “American Diabetes Association ® Applauds policymakers' Focus on Addressing High Costs of Insulin for Seven Million Americans,” 4 pages. |
| Bantle, J.P et al. (1997). “Glucose measurement in patients with diabetes mellitus with dermal interstitial fluid,” J. Lab. Clin. Med. 130:436-441. |
| Barrett et al., “Risk for Newly Diagnosed Diabetes 30 Days After SARS-CoV-2 Infection Among Persons Aged 18 Years—United States, Mar. 1, 2020-Jun. 28, 2021” MMWR Morb Mortal Wkly Rep. Jan. 14, 2022; 71(2):59-65. doi:10.15585/mmwr.mm7102e2. |
| Beckles, G.L. et al. (2016). “Disparities in the prevalence of diagnosed diabetes—United States, 1999-2002 and 2011-2014,” MMWR 65:1265-1269. |
| Biolinq, Inc. (2019). The Intelligent Continuous Glucose Monitoring System, 5 total pages. |
| Cao, J. et al. (2017). “Validation of capillary blood analysis and capillary testing mode on the epoc Point of Care system,” Pract. Lab. Med. 9:24-27. |
| Castle, J.R. et al. (2012). “The accuracy benefit of multiple amperometric glucose sensors in people with type 1 diabetes,” Diabetes Care 35:706-710. |
| Centers for Disease Control, “National Diabetes Statistics Report 2020 Estimates of Diabetes and Its Burden in the United States” (2020) 32 pages. |
| Dexcom (2020). Analyst Day Presentation, 19 total pages. |
| Dexcom (2020). Analyst Day Presentation, 27 total pages. |
| Diabetes Care (2021). “7. Diabetes Technology: Standards of Medical Care in Diabetes—2021,” Diabetes Care 44(Supplement 1):S85-S99. |
| Dunkin et al., “Scarring occurs at a critical depth of skin injury: precise measurement in a graduated dermal scratch in human volunteers” Plast Reconstr Surg. May 2007; 119(6):1722-1732. doi: 10.1097/01.prs.0000258829.07399.f0. |
| Ehrhardt et al., “Behavior Modification in Prediabetes and Diabetes: Potential Use of Real-Time Continuous Glucose Monitoring” Journal of Diabetes Science and Technology Mar. 2019; 13(2):271-275. |
| Ehrhardt et al., “Continuous Glucose Monitoring As a Behavior Modification Tool” Clin Diabetes. Apr. 2020; 38(2):126-131. doi: 10.2337/cd19-0037. |
| Ehrhardt et al., “The Effect of Real-Time Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Mellitus” Journal of Diabetes Science and Technology May 2011; 5(3):668-675. |
| Fang, M. et al. (2021). “Trends in Diabetes Treatment and Control in U.S. Adults, 1999-2018,” N. Engl. Med. 384:2219-2228. |
| Fonda et al., “The Cost-Effectiveness of Real-Time Continuous Glucose Monitoring (RT-CGM) in Type 2 Diabetes” Journal of Diabetes Science and Technology (2016) 10(4):898-904. |
| French, D.P. et al. (2008). “Original Article: Psychological Care Self-monitoring of blood glucose changed non-insulin-treated Type 2 diabetes patients' beliefs about diabetes and self-monitoring in a randomized trial,” Diav. Med. 25:1218-1228. |
| Grady, M. et al. (2017). “Examining the Impact of a Novel Blood Glucose Monitor with Color Range Indicator on Decision-Making in Patients With Type 1 and Type 2 Diabetes and its Association With Patient Numeracy Level,” JMIR Diabetes 2:e24. 11 pages. |
| Grady, M. et al. (2018). “Use of Blood Glucose Meters Featuring Color Range Indicators Improves Glycemic Control in Patients with Diabetes in Comparison to Blood Glucose Meters Without Color (Accents Study),” J. Diab. Sci. Tech. 12:1211-1219. |
| Groenendaal, W. et al. (2008). “Modeling Glucose and Water Dynamics in Human Skin,” Diab. Tech. Therap. 10:283-293. |
| Han et al., “The End of the Road for the YSI 2300 Analyzer: Where Do We Go Now?” Journal of Diabetes Science and Technology (2020) 14(3):595-600. |
| Han et al., “The YSI 2300 Analyzer Replacement Meeting Report” Journal of Diabetes Science and Technology (2020) 14(3):679-686. |
| Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group (2008). “Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes,” N. Engl. Med. 359:1464-1476. |
| Karter, A.J. et al. (2021). “Association of Real-time Continuous Glucose Monitoring With Glycemic Control and Acute Metabolic Events Among Patients With Insulin-Treated Diabetes,” JAMA 325:2273-2284. |
| Martens, T. et al. (2021). “Effect of Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Treated with Basal Insulin A Randomized Clinical Trial,” JAMA 325:2262-2272. |
| McClatchey, P.M. et al. (2019). “Fibrotic Encapsulation Is the Dominant Source of Continuous Glucose Monitor Delays,” Diabetes 68:1892-1901. |
| Neerken, S. et al. (2004). “Characterization of age-related effects in human skin: A comparative study that applies confocal laser scanning microscopy and optical coherence tomography,” J. Biomed. Optics 9:274-281. |
| Non-Final Office Action mailed on Nov. 14, 2019, for U.S. Appl. No. 29/650,794, filed Jun. 8, 2018, 10 pages. |
| Notice of Allowance mailed on Dec. 18, 2019, for U.S. Appl. No. 29/650,794, filed Jun. 8, 2018, 7 pages. |
| Notice of Allowance mailed on Sep. 29, 2022, for U.S. Appl. No. 29/774,399, filed Mar. 16, 2021, 7 pages. |
| Notice of Allowance mailed on Jan. 25, 2023, for U.S. Appl. No. 29/774,399, filed Mar. 16, 2021, 11 pages. |
| Notice of Allowance mailed on Mar. 1, 2023, for U.S. Appl. No. 29/815,797, filed Nov. 16, 2021, 10 pages. |
| Notice of Allowance mailed on May 17, 2023, for U.S. Appl. No. 29/836,984, filed Apr. 29, 2022, 7 pages. |
| Notice of Allowance mailed on May 31, 2023, for U.S. Appl. No. 29/838,870, filed May 16, 2022, 7 pages. |
| Notice of Allowance mailed on Jun. 14, 2023, for U.S. Appl. No. 29/815,797, filed Nov. 16, 2021, 9 pages. |
| Polonsky, W.H. et al. (2011). “A survey of blood glucose monitoring in patients with type 2 diabetes: Are recommendations from health care professionals being followed?” Curr. Med. Res. & Opinion 27:31-37. |
| Rigla, M. et al. (2018). “Human Subcutaneous Tissue Response to Glucose Sensors: Macrophages Accumulation Impact on Sensor Accuracy,” Diabetes Technology & Therapeutics 20:296-302. |
| Sharifi et al., “Redundancy in Glucose Sensing: Enhanced Accuracy and Reliability of an Electrochemical Redundant Sensor for Continuous Glucose Monitoring” Journal of Diabetes Science and Technology (2016) 10(3):669-678. |
| Sheikh, Z. et al. (2015). “Macrophages, Foreign Body Giant Cells and Their Response to Implantable Biomaterials,” Materials 8:5671-5701. |
| Shi, T. et al. (2016). “Modeling and Measurement of Correlation between Blood and Interstitial Glucose Changes,” J. Diab. Res. Volume 2016, 9 pages. |
| Turner et al., “Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)” The Lancet Sep. 1998; 352(9131):837-853. |
| Vigersky et al., “Short- and Long-Term Effects of Real-Time Continuous Glucose Monitoring in Patients with Type 2 Diabetes” Diabetes Care Jan. 2012; 35:32-38. |
| Wolicki et al., “Epidemiology and Prevention of Vaccine-Preventable Diseases: Chapter 6: Vaccine Administration” Centers for Disease Control and Prevention (2021) 17 pages. |
| World Health Organization, “Diabetes”, Sep. 16, 2022, 5 pages. |
| Young et al., “Glucose Self-monitoring in Non-Insulin-Treated Patients With Type 2 Diabetes in Primary Care Settings: A Randomized Trial” JAMA Intern Med. Jul. 2017; 177(7):920-929. |
| Notice of Allowance mailed on Nov. 22, 2023, for U.S. Appl. No. 29/838,870, filed May 16, 2022, 7 pages. |
| Notice of Allowance mailed on Nov. 29, 2023, for U.S. Appl. No. 29/836,984, filed Apr. 29, 2022, 7 pages. |
| Abbott, Abbott's Freestyle® Libre 3 System Receives CE Mark, Published on: Sep. 28, 2020, PRNewswire.com, Retrieved from Internet: https://www.prnewswire.com/news-releases/abbotts-freestyle-libre-3-system-receives-ce-mark--features-worlds-smallest-thinnest-sensor-with-best-in-class-performance-at-the-same-low-cost-for -people-with-diabetes-301138719.html, 2 pages. |
| American Diabetes Association, “Diabetes and Emotional Health: A Practical Guide for Health Professionals Supporting Adults with Type 1 and Type 2 Diabetes” U.S. Edition (2021), 214 pages. |
| American Diabetes Association Professional Practice Committee, “6. Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes-2024” Diabetes Care Jan. 1, 2024; 47(Suppl 1):S111-S125. |
| American Diabetes Association Professional Practice Committee, “7. Diabetes Technology: Standards of Medical Care in Diabetes-2022” Diabetes Care Jan. 1, 2022; 45(Suppl 1):S97-S112. |
| Biolinq, “Biolinq Announces Results from First-in-Man Clinical Studies Showing Feasibility of a Novel, Minimally Invasive Approach to Continuous Glucose Monitoring in the Dermis” Published on: Jun. 15, 2020, PRNewswire.com, Retrieved from Internet https://www.prnewswire.com/news-releases/biolinq-announces-results-from-first-in-man-clinical-studies-showing-feasibility-of-a-novel-minimally-invasive-approach-to-continuous-glucose-monitoring-in-the-dermis-301076992. html, 3 pages. |
| Centers for Disease Control, “National Diabetes Statistics Report” May 2024, 16 pages. |
| Delve, Dexcom G6, Published in: 2019, Designdirectory.com, Retrieved from Internet: https://www.designdirectory.com/delve/Dexcom-G6? AspxAutoDetectCookieSupport=1 (Year: 2019), 3 pages. |
| Diabetes Control and Complications Trial Research Group, “The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus” N Engl J Med Sep. 30, 1993; 329(14):977-986. |
| Diabetes.co.uk, “FDA approves new CGM the Abbott FreeStyle Libre Pro System” Published on: Sep. 29, 2016, diabetes.co.uk, Retrieved from Internet: https://www.diabetes.co.uk/news/2016/sep/fda-approves-new-cgm-the-abbott-freestyle-libre-pro-system-90611033.html (Year: 2016), 2 pages. |
| Elsayed et al., “2. Classification and Diagnosis of Diabetes: Standards of Care in Diabetes-2023” Diabetes Care Jan. 1, 2023; 46(Suppl 1):S19-S40. |
| Garg et al., “Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes”, Published on: May 31, 2022, Diabetes Technology & Therapeutics, Retrieved from Internet: https://www.liebertpub.com/doi/10.1089/dia.2022.0011 (Year: 2022), 2 pages. |
| Idrus, “Medtronic integrates CGM, Fitbit data into mobile app” Published on: Dec. 19, 2016, Fierce Biotech.com, Retrieved from Internet : https://www.fiercebiotech.com/medical-devices/medtronic-integrates-cgm-fitbit-data-into-mobile-app (Year: 2016), 1 page. |
| Mendes-Soares et al., “Assessment of a Personalized Approach to Predicting Postprandial Glycemic Responses to Food Among Individuals Without Diabetes” JAMA Network Open Feb. 1, 2019; 2(2):e188102. 13 pages. |
| Miller et al., “Hypoglycemia in patients with type 2 diabetes mellitus” Arch Intern Med Jul. 9, 2001; 161(13):1653-1659. |
| Newton et al., “Diabetic ketoacidosis in type 1 and type 2 diabetes mellitus: clinical and biochemical differences” Arch Intern Med Sep. 27, 2004; 164(17):1925-1931. |
| Non-Final Office Action for U.S. Appl. No. 29/876,134 mailed Dec. 6, 2024, 18 pages. |
| Non-Final Office Action for U.S. Appl. No. 29/890,886 dated Mar. 28, 2024, 11 pages. |
| Notice of Allowance for U.S. Appl. No. 29/871,863 dated Feb. 26, 2024, 10 pages. |
| Notice of Allowance for U.S. Appl. No. 29/885,801 mailed Nov. 22, 2024, 10 pages. |
| Notice of Allowance for U.S. Appl. No. 29/890,886 mailed Jul. 15, 2024, 7 pages. |
| Notice of Allowance for U.S. Appl. No. 29/919,992 dated Mar. 28, 2024, 8 pages. |
| PRNewswire L'Oreal Unveils Prototype First-Ever Wearable Microfluidic Sensor, posted Jan. 6, 2019[online], [retrieved Jul. 2, 2024]. Retrieved from internet,https://www.prnewswire.com/news-releases/loreal-unveils-prototype-of-first-ever-wearable-microfluidic-sensor-to-measure-skin-ph-levels-300773342.html (Year: 2019), 11 pages. |
| Roche Diabetes Care, Roche Diabetes Carey Senseonics anuncian un acuerdo de distribuci6n para el sistema Eversense® CGM, Published on: May 26, 2016, PRNewswire.com, Retrieved from Internet: https://www.prnewswire.com/news-releases/roche-diabetes-care-y-senseonics-anuncian-un-acuerdo-de-distribucion-para-el-sistema-eversense-cgm-580978821.html, 1 page. |
| Segel et al., “Hypoglycemia-associated autonomic failure in advanced type 2 diabetes” Diabetes Mar. 2002; 51(3):724-733. |
| Shivers et al., “Turn it off!: diabetes device alarm fatigue considerations for the present and the future” J Diabetes Sci Technol May 1, 2013; 7(3): 789-794. |
| Springer Link Microneedle-Based Sensor Systems for Real-Time Continuous Transdermal Monitoring of Analytes in Body Fluids, posted May 11, 2019 [online], [retrieved Jul. 2, 2024]. Retrieved from internet, https://link.springer.com/chapter/10.1007/978-3-030-17971-7_26 (Year: 2019), 23 pages. |
| Tanenbaum et al., “Diabetes Device Use in Adults With Type 1 Diabetes: Barriers to Uptake and Potential Intervention Targets” Diabetes Care Feb. 2017 40(2):181-187. |
| UK Prospective Diabetes Study (UKPDS) Group, “Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)” Lancet Sep. 12; 1998; 352(9131):837-853. |
| WaveForm Technologies Inc., “WaveForm Technologies Inc. Awarded CE Mark Approval for Their Continuous Glucose Monitoring System” Published on: Nov. 5, 2019, PRNewswire.com, Retrieved from Internet https://www.prnewswire.com/news-releases/waveform-technologies-inc-awarded-ce-mark-approval-for-their-continuous-glucose-monitoring-system-300952002.html, 1 page. |