IP Library Granted Patent US 12,402,841
Granted Patent B2
US 12,402,841 · App. 18/611,402 · Granted Sep 2, 2025

Systems and methods for use of insulin information for meal indication

Inventors: Erwin Satrya Budiman (Fremont, CA); Kenneth J. Doniger (Menlo Park, CA); Timothy C. Dunn (San Francisco, CA); Nathan C. Crouther (San Francisco, CA); Glenn Berman (Danville, CA); Howard A. Wolpert (Brookline, MA)
Assignee: Abbott Diabetes Care Inc.
A61B5/7275A61B5/14532A61B5/4848A61B5/7282A61B5/742G01N33/66G16H20/10G16H50/30G16Z99/00A61B5/4836A61B5/746G16H15/00
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,402,841
App. No.
18/611,402
Granted
Sep 2, 2025
Kind
B2
Abstract

A system and method provides a glucose report for determining glycemic risk based on an ambulatory glucose profile of glucose data over a time period, a glucose control assessment based on median and variability of glucose, and indicators of high glucose variability. Time of day periods are shown at which glucose levels can be seen. A median glucose goal and a low glucose line provide coupled with glucose variability provide a view into effects that raising or lowering the median goal would have. Likelihood of low glucose, median glucose compared to goal, and variability of glucose below median provide probabilities based on glucose data. Patterns can be seen and provide guidance for treatment.

Claims (42)

1. A method for providing a missed insulin bolus reminder, the method comprising:

receiving, by a processor of a computing device, glucose data representative of sensed glucose levels of a patient from a continuous glucose monitoring sensor;

receiving, by the processor, insulin information related to insulin administered to the patient;

determining, by the processor, an occurrence of a meal;

identifying, by the processor, a portion of the glucose data as being temporally related to the meal;

detecting, by the processor, a pattern in the portion of the glucose data temporally related to the meal; and

providing, by the computing device, a warning to notify the patient of a missed insulin bolus when the detected pattern is indicative of a rapid rise in the glucose data and no insulin information is received.

2. The method of claim 1 , wherein receiving the insulin information comprises receiving the insulin information from a dosing device.

3. The method of claim 1 , wherein the occurrence of the meal is determined based on a user input of the meal via an input of the computing device.

4. The method of claim 1 , wherein the occurrence of the meal is determined implicitly based on other collected data.

5. The method of claim 1 , wherein the occurrence of the meal is determined based on occurrence of an event.

6. The method of claim 1 , further comprising providing a recommendation based on the detected pattern.

7. The method of claim 6 , wherein the recommendation comprises a timing or a size of an insulin bolus.

8. The method of claim 1 , further comprising providing the warning to notify the patient of the missed insulin bolus when no insulin information is received for a predetermined period of time.

9. The method of claim 1 , further comprising providing the warning to notify the patient of the missed insulin bolus when no meal is determined for a predetermined period of time.

10. A system for providing a missed insulin bolus reminder, the system comprising:

a continuous glucose monitoring sensor configured to collect glucose data representative of sensed glucose levels of a patient; and

a computing device in communication with the continuous glucose monitoring sensor, wherein the computing device comprises:

a processor;

a memory coupled to the processor and storing instructions configured to cause the processor to:

receive glucose data from the continuous glucose monitoring sensor;

receive insulin information related to insulin administered to the patient;

determine an occurrence of a meal;

detect a pattern in a portion of the glucose data temporally related to the meal; and

provide a warning to notify the patient of a missed insulin bolus when the pattern is indicative of a rapid rise in the glucose data and no insulin information is received.

11. The method of claim 1 , wherein the portion of the glucose data temporally related to the meal comprises glucose data in a period of time following the meal.

12. The system of claim 10 , wherein the processor is further caused to provide the warning to notify the patient of the missed insulin bolus when no insulin information is received for a predetermined period of time.

13. The system of claim 10 , wherein the processor is further caused to provide the warning to notify the patient of the missed insulin bolus when no meal is detected for a predetermined period of time.

14. The system of claim 10 , wherein the processor is further caused to provide a recommendation based on the detected pattern.

15. The system of claim 14 , wherein the recommendation comprises a timing or a size of an insulin bolus.

16. The system of claim 10 , wherein receiving the insulin information comprises receiving the insulin information from a dosing device.

17. The system of claim 10 , wherein the occurrence of the meal is determined based on a user input of the meal via an input of the computing device.

18. The system of claim 10 , wherein the occurrence of the meal is determined based on occurrence of an event.

19. The system of claim 10 , wherein the computing device is a smartphone.

20. A computing device, comprising:

a processor;

a memory coupled to the processor and storing instructions configured to cause the processor to:

receive glucose data from a continuous glucose monitoring sensor in communication with the computing device, wherein the continuous glucose monitoring sensor is configured to collect glucose data representative of sensed glucose levels of a patient;

receive insulin information related to insulin administered to the patient;

determine an occurrence of a meal;

detect a pattern in a portion of the glucose data temporally related to the meal; and

provide a warning to notify the patient of a missed insulin bolus when the pattern is indicative of a rapid rise in the glucose data and no insulin information is received.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 10, 2025
From: BUDIMAN, ERWIN S.; DONIGER, KENNETH J.; DUNN, TIMOTHY C.; CROUTHER, NATHAN C.; BERMAN, GLENN H.; WOLPERT, HOWARD A.; HAYTER, GARY A.
To: ABBOTT DIABETES CARE INC.
Reel/Frame 069873/0051 →
Continuity (5)
Continuation 16005234 · Jun 11, 2018
Continuation 14214901 · Mar 15, 2014
Provisional Application 61922765 · Dec 31, 2013
Provisional Application 61799139 · Mar 15, 2013
Related Publication 20240225559A1 · Jul 11, 2024
References Cited (220)
US 4695954A · Rose et al. · 1987 [cited by applicant]
US 4731726A · Allen, III · 1988 [cited by applicant]
US 4779199A · Yoneda et al. · 1988 [cited by applicant]
US 4817044A · Ogren · 1989 [cited by applicant]
US 5019974A · Beckers · 1991 [cited by applicant]
US 5216597A · Beckers et al. · 1993 [cited by applicant]
US 5251126A · Kahn et al. · 1993 [cited by applicant]
US 5307263A · Brown · 1994 [cited by applicant]
US 5319363A · Welch et al. · 1994 [cited by applicant]
US 5341291A · Roizen et al. · 1994 [cited by applicant]
US 5376070A · Purvis et al. · 1994 [cited by applicant]
US 5500854A · Uotila et al. · 1996 [cited by applicant]
US 5558638A · Evers et al. · 1996 [cited by applicant]
US 5569186A · Lord et al. · 1996 [cited by applicant]
US 5590648A · Mitchell et al. · 1997 [cited by applicant]
US 5626144A · Tacklind et al. · 1997 [cited by applicant]
US 5665065A · Colman et al. · 1997 [cited by applicant]
US 5704366A · Tacklind et al. · 1998 [cited by applicant]
US 5713856A · Eggers et al. · 1998 [cited by applicant]
US 5772586A · Heinonen et al. · 1998 [cited by applicant]
US 5822715A · Worthington et al. · 1998 [cited by applicant]
US 5878384A · Johnson et al. · 1999 [cited by applicant]
US 5925021A · Castellano et al. · 1999 [cited by applicant]
US 5946659A · Lancelot et al. · 1999 [cited by applicant]
US 5960403A · Brown · 1999 [cited by applicant]
US 5974389A · Clark et al. · 1999 [cited by applicant]
US 5997476A · Brown · 1999 [cited by applicant]
US 6022315A · Iliff · 2000 [cited by applicant]
US 6024699A · Surwit et al. · 2000 [cited by applicant]
US 6049764A · Stahl · 2000 [cited by applicant]
US 6081786A · Barry et al. · 2000 [cited by applicant]
US 6134504A · Douglas et al. · 2000 [cited by applicant]
US 6144922A · Douglas et al. · 2000 [cited by applicant]
US 6175752B1 · Say et al. · 2001 [cited by applicant]
US 6188988B1 · Barry et al. · 2001 [cited by applicant]
US 6206829B1 · Iliff · 2001 [cited by applicant]
US 6225901B1 · Kail, IV · 2001 [cited by applicant]
US 6234964B1 · Iliff · 2001 [cited by applicant]
US 6270455B1 · Brown · 2001 [cited by applicant]
US 6277071B1 · Hennessy et al. · 2001 [cited by applicant]
US 6336900B1 · Alleckson et al. · 2002 [cited by applicant]
US 6338713B1 · Chamoun et al. · 2002 [cited by applicant]
US 6352505B1 · Bortz · 2002 [cited by applicant]
US 6368273B1 · Brown · 2002 [cited by applicant]
US 6379301B1 · Worthington et al. · 2002 [cited by applicant]
US 6390986B1 · Curcie et al. · 2002 [cited by applicant]
US 6406426B1 · Reuss et al. · 2002 [cited by applicant]
US 6418346B1 · Nelson et al. · 2002 [cited by applicant]
US 6422061B1 · Sunshine et al. · 2002 [cited by applicant]
US 6450956B1 · Rappaport et al. · 2002 [cited by applicant]
US 6524240B1 · Thede · 2003 [cited by applicant]
US 6540672B1 · Simonsen et al. · 2003 [cited by applicant]
US 6544174B2 · West et al. · 2003 [cited by applicant]
US 6544212B2 · Galleu et al. · 2003 [cited by applicant]
US 6551243B2 · Bocionek et al. · 2003 [cited by applicant]
US 6558351B1 · Steil et al. · 2003 [cited by applicant]
US 6575900B1 · Zweig et al. · 2003 [cited by applicant]
US 6604050B2 · Trippel et al. · 2003 [cited by applicant]
US 6611846B1 · Stoodley · 2003 [cited by applicant]
US 6635016B2 · Finkelshteins · 2003 [cited by applicant]
US 6635167B1 · Batman et al. · 2003 [cited by applicant]
US 6645142B2 · Braig et al. · 2003 [cited by applicant]
US 6656114B1 · Poulsen et al. · 2003 [cited by applicant]
US 6692436B1 · Bluth et al. · 2004 [cited by applicant]
US 6781522B2 · Sleva et al. · 2004 [cited by applicant]
US 6799149B2 · Hartlaub · 2004 [cited by applicant]
US 6804558B2 · Haller et al. · 2004 [cited by applicant]
US 6872200B2 · Mann et al. · 2005 [cited by applicant]
US 6915170B2 · Engleson et al. · 2005 [cited by applicant]
US 6923763B1 · Kovatchev et al. · 2005 [cited by applicant]
US 7241265B2 · Cummings et al. · 2007 [cited by applicant]
US 7920907B2 · McGarraugh et al. · 2011 [cited by applicant]
US 8409093B2 · Bugler · 2013 [cited by applicant]
US 8758245B2 · Ray et al. · 2014 [cited by applicant]
US 9579231B2 · Galvin · 2017 [cited by applicant]
US 20010039503A1 · Chan et al. · 2001 [cited by applicant]
US 20030114836A1 · Estes et al. · 2003 [cited by applicant]
US 20030208113A1 · Mault et al. · 2003 [cited by applicant]
US 20030211617A1 · Jones · 2003 [cited by applicant]
US 20030216628A1 · Bortz et al. · 2003 [cited by applicant]
US 20040091424A1 · Asano et al. · 2004 [cited by applicant]
US 20050027182A1 · Siddiqui et al. · 2005 [cited by applicant]
US 20050038332A1 · Saidara et al. · 2005 [cited by applicant]
US 20050119540A1 · Potts et al. · 2005 [cited by applicant]
US 20050159656A1 · Hockersmith et al. · 2005 [cited by applicant]
US 20050187789A1 · Hattlestad et al. · 2005 [cited by applicant]
US 20050214892A1 · Kovatchev et al. · 2005 [cited by applicant]
US 20050267780A1 · Ray et al. · 2005 [cited by applicant]
US 20060010098A1 · Goodnow et al. · 2006 [cited by applicant]
US 20060106644A1 · Koo et al. · 2006 [cited by applicant]
US 20060173260A1 · Gaoni et al. · 2006 [cited by applicant]
US 20060189863A1 · Peyser et al. · 2006 [cited by applicant]
US 20060264895A1 · Flanders · 2006 [cited by applicant]
US 20060276771A1 · Galley et al. · 2006 [cited by applicant]
US 20070016449A1 · Cohen et al. · 2007 [cited by applicant]
US 20070033074A1 · Nitzan et al. · 2007 [cited by applicant]
US 20070106135A1 · Sloan et al. · 2007 [cited by applicant]
US 20070149874A1 · Say et al. · 2007 [cited by applicant]
US 20070179352A1 · Randlov et al. · 2007 [cited by applicant]
US 20070179370A1 · Say et al. · 2007 [cited by applicant]
US 20070208244A1 · Brauker et al. · 2007 [cited by applicant]
US 20080071580A1 · Marcus et al. · 2008 [cited by applicant]
US 20080119710A1 · Reggiardo et al. · 2008 [cited by applicant]
US 20080154513A1 · Kovatchev et al. · 2008 [cited by applicant]
US 20080234943A1 · Ray et al. · 2008 [cited by applicant]
US 20080234992A1 · Ray et al. · 2008 [cited by applicant]
US 20080235053A1 · Ray et al. · 2008 [cited by applicant]
US 20080255438A1 · Saidara et al. · 2008 [cited by applicant]
US 20080262469A1 · Brister et al. · 2008 [cited by applicant]
US 20080300572A1 · Rankers et al. · 2008 [cited by applicant]
US 20090055149A1 · Hayter et al. · 2009 [cited by applicant]
US 20090105573A1 · Malecha · 2009 [cited by applicant]
US 20090171589A1 · Kovatchev · 2009 [cited by applicant]
US 20090192380A1 · Shariati et al. · 2009 [cited by applicant]
US 20090216102A1 · Say et al. · 2009 [cited by applicant]
US 20090221890A1 · Saffer et al. · 2009 [cited by applicant]
US 20090240127A1 · Ray · 2009 [cited by applicant]
US 20100094251A1 · Estes · 2010 [cited by examiner]
US 20100152554A1 · Steine et al. · 2010 [cited by applicant]
US 20100161236A1 · Cohen et al. · 2010 [cited by applicant]
US 20100191472A1 · Doniger et al. · 2010 [cited by applicant]
US 20100198314A1 · Wei · 2010 [cited by applicant]
US 20100332445A1 · Ray et al. · 2010 [cited by applicant]
US 20110077494A1 · Doniger et al. · 2011 [cited by applicant]
US 20110130746A1 · Budiman · 2011 [cited by applicant]
US 20110257495A1 · Hoss · 2011 [cited by examiner]
US 20110264378A1 · Breton et al. · 2011 [cited by applicant]
US 20120143021A1 · Nagar · 2012 [cited by applicant]
US 20120277619A1 · Starkebaum · 2012 [cited by applicant]
US 20120283694A1 · Yodfat et al. · 2012 [cited by applicant]
US 20130035575A1 · Mayou et al. · 2013 [cited by applicant]
US 20130321425A1 · Greene et al. · 2013 [cited by applicant]
US 20130338630A1 · Agrawal et al. · 2013 [cited by applicant]
US 20140030748A1 · Schaible · 2014 [cited by applicant]
US 20140088392A1 · Bernstein et al. · 2014 [cited by applicant]
US 20140088393A1 · Bernstein et al. · 2014 [cited by applicant]
US 20140118166A1 · Hampapuram · 2014 [cited by examiner]
US 20140129151A1 · Bhavaraju · 2014 [cited by examiner]
US 20140275748A1 · Dunki-Jacobs · 2014 [cited by applicant]
US 20140350369A1 · Budiman · 2014 [cited by applicant]
US 20150190098A1 · Patek · 2015 [cited by applicant]
US 20190053765A1 · Budiman · 2019 [cited by applicant]
GB 2443434A · 2008 [cited by applicant]
JP 2001245900A · 2001 [cited by applicant]
JP 2003500744A · 2003 [cited by applicant]
JP 2004024699A · 2004 [cited by applicant]
WO WO199956613A1 · 1999 [cited by applicant]
WO WO200004512A2 · 2000 [cited by applicant]
WO WO200205702A2 · 2002 [cited by applicant]
WO WO2004009161A1 · 2004 [cited by applicant]
WO WO2005081170A2 · 2005 [cited by applicant]
WO WO2006079867A1 · 2006 [cited by applicant]
WO WO2008030347A2 · 2008 [cited by applicant]
WO WO2008151452A1 · 2008 [cited by applicant]
WO WO2009049252A1 · 2009 [cited by applicant]
WO WO2009146119A2 · 2009 [cited by applicant]
WO WO2011041007A1 · 2011 [cited by applicant]
WO WO2011060923A2 · 2011 [cited by applicant]
Bergenstal, R., et al., “Recommendations for Standardizing Glucose Reporting and Analysis to Optimize Clinical Decision Making in Diabetes: The Ambulatory Glucose Profile (AGP)”, Diabetes Technology & Therapeutics, 2011… [cited by applicant]
Breton, M., et al., “A Model of Self-Treatment Behavior, Glucose Variability, and Hypoglycemia-Associated Autonomic Failure in Type 1 Diabetes”, Journal of Diabetes Science and Technology, 2007, vol. 1, No. 3, pp. 331-3… [cited by applicant]
Brownlee, M., et al., “Glycemic Variability: A Hemoglobin A1c-Independent Risk Factor for Diabetic Complications”, JAMA, 2006, vol. 295, No. 14, pp. 1707-1708. [cited by applicant]
Cunningham, David D. and Stenken, Julia A., Editors, “In Vivo Glucose Sensing,” Chemical Analysis, vol. 174, John Wiley & Sons, Inc., Hoboken, NJ 2010; 466 pages. [cited by applicant]
Dexcom's 7-Day Continuous Glucose Monitoring System, Jun. 1, 2007, https://newatlas.com/; 1 page. [cited by applicant]
Exhibit CP-3, Expert Report of Dr. Cesar C. Palerm, Sep. 20, 2022: “In Vivo Glucose Sensing, Chemical Analysis, A Series of Monographs on Analytical Chemistry and Its Applications,” vol. 174, Wiley (2010) Chp. 5, pp. 14… [cited by applicant]
Exhibit CP-4, Expert Report of Dr. Cesar C. Palerm, Sep. 20, 2022, “Animas® VibeTM, the First Integrated Offering from Animas Corporation and Dexcom, Inc, Receives European CE Mark Approval”, Products & Operating Compan… [cited by applicant]
Exhibit CP-6, Second Expert Report of Dr. Cesar C. Palerm, Oct. 21, 2022, Bailey, T.S et al., “Reduction in Hemoglobin Ale with Real-Time Continuous Glucose Monitoring: Results from a 12-Week Observational Study” Diabet… [cited by applicant]
Exhibit CP-7, Second Expert Report of Dr. Cesar C. Palerm, Oct. 21, 2022, Garg, S et al., “Improvement in Glycemic Excursions with a Transcutaneous, Real-Time Continuous Glucose Sensor”, Diabetes Care, 2006, 29(12):44-5… [cited by applicant]
Exhibit CP-8, Second Expert Report of Dr. Cesar C. Palerm, Oct. 21, 2022, Garg, S. et al., Relationship of Fasting and Hourly Blood Glucose Levels to HbAlc Values, Diabetes Care, 2006, 6(12):2644-2649. [cited by applicant]
Exhibit CP-10, Second Expert Report of Dr. Cesar C. Palerm, Oct. 21, 2022, “Standards of Medical Care in Diabetes—2009” Position Statement, American Diabetes Association, 2009, Diabetes Care, 32(1):S13-S61. [cited by applicant]
Exhibit No. 2, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Diabetes Mellitus,” The European Agency for the Evaluat… [cited by applicant]
Exhibit No. 3, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “Defining and Reporting Hypoglycemia in Diabetes”, American Diabetes Association, Diabetes Care, 2005, 28(5):1245-1249. [cited by applicant]
Exhibit No. 4, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Amiel, S. A., et al., “Hypoglycaemia in Type 2 diabetes”, Diabetic Medicine, 2008, 25:245-254. [cited by applicant]
Exhibit No. 5, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Swinnen, S.G.H.A. et al., “Changing the glucose cut-off values that define Hypoglycaemia has a major effect on reported frequencies of hypogly… [cited by applicant]
Exhibit No. 6, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Frier, B.M. “Defining hypoglycaemia: what level has clinical relevance?”, Diabetologia, 2009, 52:31-34. [cited by applicant]
Exhibit No. 7, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Cryer, P.E. “Preventing Hypoglycaemia: what is the appropriate glucose alert value?” Diabetologia, 2009, 53:35-37. [cited by applicant]
Exhibit No. 8, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Choudhary, P. et al., “Hypoglycaemia in the treatment of diabetes mellitus” Oxford Textbook of Endocrinology and Diabetes, 2011 pp. 1849-1860. [cited by applicant]
Exhibit No. 9, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus” European Medicines Agency, May… [cited by applicant]
Exhibit No. 10, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “Type 1 Diabetes Research Roadmap, Identifying the strengths and weaknesses, gaps and opportunities of UK type 1 diabetes research; clearing … [cited by applicant]
Exhibit No. 11, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long- Term Complications in Insulin-Dependent Diabetes M… [cited by applicant]
Exhibit No. 12, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, National Service Framework for Diabetes: Standards, Dept. of Health, 2002, 48 pages. [cited by applicant]
Exhibit No. 13, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Amiel, S. et al., “Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustme… [cited by applicant]
Exhibit No. 14, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “Type 1 diabetes: diagnosis and management of type 1 diabetes in children, young people and adults” National Institute for Clinical Excellenc… [cited by applicant]
Exhibit No. 15, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Pickup, John C. “Glucose monitoring”, Oxford Textbook of Endocrinology and Diabetes, 2011, pp. 1861-1869. [cited by applicant]
Exhibit No. 16, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Pickup, J.C et al., “Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blo… [cited by applicant]
Exhibit No. 17, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “Diabetes (type 1), PSP Top 10”, James, Lind Alliance, Priority Setting Partnerships, 2011, 4 pages. [cited by applicant]
Exhibit No. 20, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “Continuous Glucose Sensors: Continuing Questions about Clinical Accuracy” Journal of Diabetes Science and Technology, 2007; 1(5):669-675. [cited by applicant]
Exhibit No. 21, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Devries, J.H. “Glucose Sensing Issues For the Artificial Pancreas” Journal of Diabetes Science and Technology, 2008, 2(4):732-734. [cited by applicant]
Exhibit No. 23, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Internet Archive, WayBack Machine, Medtronic MiniMed, 2004, 20 pages. [cited by applicant]
Exhibit No. 24, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “Glucowatch G2, Automatic Glucose Biographer and Autosensors,” 2002, 70 pages. [cited by applicant]
Exhibit No. 25, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “Guardian® REAL-Time Continuous Glucose Monitoring System, User Guide,” Medtronic MiniMed, 2006, 181 pages. [cited by applicant]
Exhibit No. 26, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “CGMS® iProTM Continuous Glucose Recorder, User Guide,” Medtronic MiniMed, 2007, 36 pages. [cited by applicant]
Exhibit No. 27, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “Freestyle Navigator Continuous Glucose Monitoring System, User Guide,” Abbott, 2008, 2010, 135 pages. [cited by applicant]
Exhibit No. 28, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Freestyle Navigator II Continuous Glucose Monitoring System, User's Manual, Abbott, 2011-2013, 21 pages. [cited by applicant]
Exhibit No. 29, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, “Dexcom G4 Continuous Glucose Monitoring System, User's Guide,” Dexcom, 2013, 156 pages. [cited by applicant]
Exhibit No. 30, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Revised Specification for publication No. US2007/208244A1, 2007, 170 pages. [cited by applicant]
Exhibit No. 31, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Revised Specification for EP625, 2008, 30 pages. [cited by applicant]
Exhibit No. 32, to the Expert Report of Professor Nick Oliver, Sep. 20, 2022, Puhr, S. et al., “Real-World Hypoglycemia Avoidance with a Predictive Low Glucose Alert Does Not Depend on Frequent Screen Views”, Journal of… [cited by applicant]
Exhibit No. 37, to the Second Expert Report of Professor Nick Oliver, Oct. 21, 2022, Oliver, N.S., et al., “Glucose sensors: a review of current and emerging technology”, Diabetic Medicine, 2009, 26:197-210. [cited by applicant]
Extended Search Report for EP 14762430.8. [cited by applicant]
Freestyle Navigator Continuous Glucose Monitoring System, User's Guide, Abbott Diabetes Care Inc., May 2008; 195 pages. [cited by applicant]
Fritzsche, G., et al., “The Use of a Computer Program to Calculate the Mean Amplitude of Glycemic Excursions”, Diabetes Technology & Therapeutics, 2011, vol. 13, No. 3, pp. 319-325. [cited by applicant]
Getting Started with Carelink Personal Software Continuous Glucose Monitoring; Medtronic, 2009, 28 pages. [cited by applicant]
Harvey, R.A., et al., “Clinically Relevant Hypoglycemia Prediction Metrics for Event Mitigation”, Diabetes Technology & Therapeutics, 2012, vol. 14, No. 8, pp. 719-727. [cited by applicant]
Hughes, C.A., et al.,“Hypoglycemia Prevention via Pump Attenuation and Red-Yellow-Green “Traffic” Lights Using Continuous Glucose Monitoring and Insulin Pump Data”, Journal of Diabetes Science and Technology, 2010, vol.… [cited by applicant]
ISR and Written Opinion for PCT/US2014/030075. [cited by applicant]
Kilpatrick, E. S., “The Effect of Glucose Variability on the Risk of Microvascular Complications in Type 1 Diabetes”, Diabetes Care, 2006, vol. 29, No. 7, pp. 1486-1490. [cited by applicant]
Kovatchev, B. P., et al., “Quantifying Temporal Glucose Variability in Diabetes via Continuous Glucose Monitoring: Mathematical Methods and Clinical Application”, Diabetes Technology & Therapeutics, 2005, vol. 7, No. 6,… [cited by applicant]
Letter from Department of Health and Human Services to DexCom Inc. regarding STS-7 Continuous Glucose Monitoring System, dated May 31, 2007; 95 pages; Anlage TW 25, Taylor Wessing, Statement of Defence in [cited by applicant]
Mazze, R. S., “Ambulatory Glucose Profile: Representation of Verified Self-Monitored Blood Glucose Data”, Diabetes Care, 1987, vol. 10, No. 1, pp. 111-117. [cited by applicant]
Mazze, R. S., “Characterizing Glucose Exposure for Individuals with Normal Glucose Tolerance Using Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis”, Diabetes Technology & Therapeutics, 2008, vol. 1… [cited by applicant]
PMA Approvals FDA—webpage available at: https://www.fda.gov; 3 pages. [cited by applicant]
PMA database search for Freestyle Navigator Continuous Glucose Monitor—https://www.fda.gov; 6 pages. [cited by applicant]
Rodbard, D., “Optimizing Display, Analysis, Interpretation and Utility of Self-Monitoring of Blood Glucose (SMBG) Data for Management of Patients with Diabetes”, Journal of Diabetes Science and Technoloav, 2007, vol. 1,… [cited by applicant]
Sandham, William et al., “Blood Glucose Prediction for Diabetes Therapy Using a Recurrent Artificial Neural Network,” 9th European Signal Processing Conference (EUSIPCO 1998), 1998, pp. 1-4. [cited by applicant]
Sparacino, Giovanni et al., “Glucose Concentration can be Predicted Ahead in Time From Continuous Glucose Monitoring Sensor Time-Series,” IEEE Transactions on Biomedical Engineering, Vo. 54, No. 5, May 2007; 7 pages. [cited by applicant]
STS-7 Continuous Glucose Monitoring System User's Guide, 74 pages; 2007; Anlage TW 11 D5a, Taylor Wessing, Statement of Defence in [cited by applicant]
Summary of Safety and Effectiveness Data for STS-7 Continuous Glucose Monitoring System, Notice of Approval dated May 31, 2007; 14 pages; Anlage TW 11 D5b, Taylor Wessing, Statement of Defence in [cited by applicant]
U.S. Pat. No. 8,282,549 B2, Brauker et al., published Oct. 9, 2012; 73 pages; Anlage TW 2, Taylor Wessing, Statement of Defence in [cited by applicant]
Wilson, D. M., “The Accuracy of the Freestyle Navigator Continuous Glucose Monitoring System in Children With Type 1 Diabetes”, Diabetes Care, 2007, vol. 30, No. 1, pp. 59-64. [cited by applicant]
Extended European Search Report in European Patent Application No. 24169003.1, mailed Oct. 21, 2024; 6 pages. [cited by applicant]