Automated control of an adaptive bihormonal, dual-sensor artificial pancreas and evaluation during inpatient studies

IEEE Transactions on Biomedical Engineering

Volumn 61, Issue 10, 2014, Pages 2569-2581

  Jacobs, Peter G ^a   El Youssef, Joseph ^a   Castle, Jessica ^a   Bakhtiani, Parkash ^a   Branigan, Deborah ^a   Breen, Matthew ^b   Bauer, David ^b   Preiser, Nicholas ^a   Leonard, Gerald ^b   Stonex, Tara ^b   Ward, W Kenneth ^a,b  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b LEGACY RESEARCH   (United States)

Author keywords

Artificial pancreas; bihormonal insulin delivery; glucagon delivery; glucose sensor

Indexed keywords

ARTIFICIAL PANCREAS; AUTOMATED CONTROL; DUAL SENSOR; GLUCAGON DELIVERY; INSULIN DELIVERY;

GLUCOSE SENSORS;

GLUCOSE; INSULIN; ANTIDIABETIC AGENT; GLUCAGON; GLUCOSE BLOOD LEVEL; HORMONE;

ADULT; AGED; ARTICLE; ARTIFICIAL PANCREAS; CLINICAL ARTICLE; FEMALE; GLUCOSE BLOOD LEVEL; GLUCOSE HOMEOSTASIS; GLUCOSE SENSOR; GLYCEMIC CONTROL; HORMONE ACTION; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN PUMP; MALE; ALGORITHM; ANALYSIS; BIOLOGICAL MODEL; BLOOD GLUCOSE MONITORING; HOSPITAL PATIENT; INSULIN INFUSION; MIDDLE AGED;

ADULT; ALGORITHMS; BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; GLUCAGON; HORMONES; HUMANS; HYPOGLYCEMIC AGENTS; INPATIENTS; INSULIN; INSULIN INFUSION SYSTEMS; MIDDLE AGED; MODELS, BIOLOGICAL; PANCREAS, ARTIFICIAL;

EID: 84907469976     PISSN: 00189294     EISSN: 15582531     Source Type: Journal    
DOI: 10.1109/TBME.2014.2323248     Document Type: Article

References (46)

1. A. M. Albisser, B. S. Leibel, and T. G. Ewart, "Clinical control of diabetes by the artificial pancreas, " Diabetes, vol. 23, no. 5, pp. 397-404, 1974.
2. A. M. Albisser, B. S. Leibel, T. G. Ewart, Z. Davidovac, C. K. Botz, and W. Zingg, "An artificial endocrine pancreas, " Diabetes, vol. 23, no. 5, pp. 389-396, 1974.
3. H. Thabit and R. Hovorka, "Closed-loop insulin delivery in type 1 diabetes, " Endocrinol. Metab. Clin. North Amer., vol. 41, no. 1, pp. 105-117, 2012.
4. J. Radziuk, "The artificial pancreas, " Diabetes, vol. 61, no. 9, pp. 2221-2224, 2012.
5. B. J. Gilligan, M. Shults, B. Rhodes, P. G. Jacobs, J. H. Brauker, T. J. Pintar, and S. J. Updike, "Feasibility of continuous long term glucose monitoring from a subcutaneous glucose sensor in humans, " Diabetes Technol. Ther., vol. 6, no. 3, pp. 378-386, 2004.
6. J. Mastrototaro, "The MiniMed continuous glucose monitoring system, " Diabetes Technol. Ther., vol. 2, Suppl. 1, pp. S13-S18, 2000.
7. B. W. Bode, "Clinical utility of the continuous glucose monitoring system, " Diabetes Technol. Ther., vol. 2, Suppl. 1, pp. S35-S41, 2000.
8. E. F. Pfeiffer, C. Thum, and A. H. Clemens, "The artificial beta cell-A continuous controlofblood sugar by external regulationofinsulin infusion (glucose controlled insulin infusion system), " Horm. Metab. Res., vol. 6, no. 5, pp. 339-342, 1974.
9. A. H. Clemens, P. H. Chang, and R. W. Myers, "The development of Biostator, a glucose controlled insulin infusion system (GCIIS), " Horm. Metab. Res., vol. 7, pp. 23-33, 1977.
10. G. M. Steil, K. Rebrin, R. Janowski, C. Darwin, and M. F. Saad, "Modeling beta-cell insulin secretion-Implications for closed-loop glucose home-ostasis, " Diabetes Technol. Ther., vol. 5, no. 6, pp. 953-964, 2003.
11. E. M. Watson, M. J. Chappell, F. Ducrozet, S. M. Poucher, and J. W. T. Yates, "A new general glucose homeostatic model using a proportional-integral-derivative controller, " Comput. Methods Prog. Biomed., vol. 102, pp. 119-129, 2011.
12. S. A. Weinzimer, G. M. Steil, K. L. Swan, J. Dziura, N. Kurtz, and W. V. Tamborlane, "Fully automated closed-loop insulin delivery versus semiautomated hybrid control in pediatric patients with type 1 diabetes using an artificial pancreas, " Diabetes Care, vol. 31, no. 5, pp. 934-939, 2008.
13. D. Pinky, F.J. Doyle, and E.N. Pistikopoulos, "Model-based blood glucose control for type 1 diabetes via parametric programming, " IEEE Trans. Biomed. Eng., vol. 53, no. 8, pp. 1478-1491, Aug. 2006.
14. A. Abu-Rmileh and W. Garcia-Gabin, "A gain-scheduling model predictive controller for blood glucose control in type 1 diabetes, " IEEE Trans. Biomed. Eng., vol. 57, no. 10, pp. 2478-2484, Oct. 2010.
15. K. Zarkogianni, A. Vazeou, S. G. Mougiakakou, A. Prountzou, and K. S. Nikita, "An insulin infusion advisory system based on autotuning nonlinear model-predictive control, " IEEE Trans. Biomed. Eng., vol. 58, no. 9, pp. 2467-2477, Sep. 2011.
16. A. Magni, D. M. Raimondo, L. Bossi, C. D. Man, G. D. Nicolao, B. Kovatchev, and C. Cobelli, "Model predictive control of type 1 diabetes: An in silico trial, " J. Diabetes Sci. Technol., vol. 1, no. 6, pp. 804-812, 2007.
17. M. Breton, A. Farret, D. Bruttomesso, S. Anderson, L. Magni, S. Patek, C. M. Dalla, J. Place, S. Demartini, S. D. Favero, C. Toffanin, C.-K. Hughes, E. Dassau, H. Zisser, F. J. Doyle, G. D. Nicolao, A. Avogaro, C. Cobelli, E. Renard, and B. Kovatchev, "Fully integrated artificial pancreas in Type 1 diabetes, modular closed-loop glucose control maintains near normoglycemia, " Diabetes, vol. 71, pp. 2230-2237, Sep. 2012.
18. D. Bruttomesso, A. Farret, S. Costa, M. C. Marascotti, M. Vettore, A. Avogaro, A. Tiengo, C. Dalla Man, J. Place, A. Facchinetti, S. Guerra, L. Magni, G. De Nicolao, C. Cobelli, E. Renard, and A. Maran, "Closed-loop artificial pancreas using subcutaneous glucose sensing and insulin delivery and a model predictive control algorithm: Preliminary studies in Padova and Montpellier, " J. Diabetes Sci. Technol., vol. 3, no. 5, pp. 1014-1021, 2009.
19. B. Kovatchev, C. Cobelli, E. Renard, S. Anderson, M. Breton, S. Patek, W. Clarke, D. Bruttomesso, A. Maran, S. Costa, A. Avogaro, C. Dalla Man, A. Facchinetti, L. Magni, G. De Nicolao, J. Place, and A. Farret, "Multinational study of subcutaneous model-predictive closed-loop control in type 1 diabetes mellitus: summary of results, " J. Diabetes Sci. Technol., vol. 4, no. 6, pp. 1374-1381, 2010.
20. R. Nimri, I. Muller, E. Atlas, S. Miller, O. Kordonouri, N. Bratina, C. Tsioli, M. A. Stefanija, T. Danne, T. Battelino, and M. Phillip, "Night glucose control with MD-Logic artificial pancreas in home setting: A single blind, randomized crossover trial-interim analysis, " Pediatr. Diabetes, vol. 15, pp. 91-99, 2014.
21. E. Atlas, R. Nimri, S. Miller, E. A. Grunberg, and M. Phillip, "MD-Logic artificial pancreas system: A pilot study in adults with type 1 diabetes, " Diabetes Care, vol. 33, no. 5, pp. 1072-1076, 2010.
22. C. J. Fernandez, S. Gonzalez-Perez, and J. C. Ramos-Diaz, "Artificial neural networks for closed loop control of in silico and ad hoc type 1 diabetes, " Comput. Methods. Programs Biomed., vol. 106, no. 1, pp. 55-66, 2011.
23. P. H. Herrero, P. Georgiou, N. Oliver, D. G. Johnston, and C. Toumazou, "A bio-inspired glucose controller based on pancreatic B-cell physiology, " J. Diabetes Sci. Technol., vol. 6, no. 3, pp. 606-616, 2012.
24. A. K. El-Jabali, "Neural network modeling and control of type 1 diabetes mellitus, " Bioprocess Biosyst. Eng., vol. 27, pp. 75-79, 2005.
25. P. Grant, "A new approach to diabetic control: Fuzzy logic and insulin pump technology, " Med. Eng. Phys, vol. 29, pp. 824-827, 2007.
26. M. Ibbini and M. Masadeh, "A fuzzy logic based closed-loop control system for blood glucose level regulation in diabetics, " J. Med. Eng. Technol., vol. 29, pp. 64-69, 2005.
27. Diabetes Control And Complications 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., vol. 329, no. 14, pp. 977-986, 1993.
28. R. M. Bergenstal, D. C. Klonoff, S. K. Garg, B. W. Bode, M. Meredith, R. H. Slover, A. J. Ahmann, J. B. Welsh, S. W. Lee, and F. R. Kaug-man, "Threshold-based insulin pump interruption for reduction of hypo-glycemia, " N. Engl. J. Med., vol. 369, no. 3, pp. 224-232, 2013.
29. G. Holmes, L. Galitz, P. Hu, and W. Lyness, "Pharmacokinetics of insulin aspart in obesity, renal impairment, or hepatic impairment, " B r. J. Clin. Pharmacol., vol. 60, no. 5, pp. 469-476, 2005.
30. J. R. Castle, J. M. Engle, J. El Youssef, R. G. Massoud, K. C. Yuen, R. Kagan, and W. K. Ward, " Novel use of glucagon in a closed loop system for prevention of hypoglycemia in type 1 diabetes, " Diabetes Care, vol. 33, no. 6, pp. 1282-1287, Mar. 2010.
31. S. J. Russell, F. H. El-Khatib, D. M. Nathan, K. L. Magyar, J. Jiang, and E. R. Damiano, "Blood glucose control in type 1 diabetes with a bihor-monal bionic endocrine pancreas, " Diabetes Care, vol. 35, pp. 2148-2155, Nov. 2012.
32. F. H. El-Khatib, S. J. Russell, D. M. Nathan, R. G. Sutherlin, and E. R. Damiano, "A bihormonal closed-loop artificial pancreas for type 1 diabetes, " Sci. Transl. Med., vol. 2, no. 27, pp. 182-192, Apr. 2010.
33. F. H. El-Khatib, J. Jiang, and E. R. Damiano, "Adaptive closed-loop control provides blood-glucose regulation using dual subcutaneous insulin and glucagon infusion in diabetic swine, " J. Diabetes Sci. Technol, vol. 1, no. 2, pp. 181-192, Mar. 2007.
34. A. Haidar, L. Legault, M. Dallaire, A. Alkhateeb, A. Coriati, V. Messier, P. Cheng, M. Millette, B. Boulet, and R. Rabasa-Lhoret, "Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: A randomized crossover controlled trial, " Can. Med. Assoc. J., vol. 185, no. 4, pp. 297-305, 2013.
35. J. El Youssef, J. R. Castle, D. L. Branigan, R. G. Massoud, M. E. Breen, P. G. Jacobs, B. W. Bequette, and W. K. Ward, "A controlled study of the effectiveness of an adaptive closed-loop algorithm to minimize corticosteroid-induced stress hyperglycemia in type 1 diabetes, " J. Diabetes Sci. Technol., vol. 5, no. 6, pp. 1312-1326, Nov. 2011.
36. B. Gopakumaran, H. M. Duman, D. P. Overholser, I. F. Federiuk, M. J. Quinn, M. D. Wood, and W. K. Ward, "A novel insulin delivery algorithm in rats with type 1 diabetes: The fading memory proportional-derivative method, " Artif. Organs, vol. 29, no. 8, pp. 599-607, Aug. 2005.
37. P. G. Jacobs, J. El Youssef, J. R. Castle, J. M. Engle, D. L. Branigan, P. Johnson, R. Massoud, A. Kamath, and W. K. Ward, "Development of a fully automated closed loop artificial pancreas control system with dual pump delivery of insulin and glucagon, " in Proc. IEEE Conf. Eng. Med. Biol. Soc., 2011, pp. 397-400.
38. F. Cameron, G. Niemeyer, and B. A. Buckingham, "Probabilistic evolving meal detection and estimation of meal total glucose appearance, " J. Diabetes Sci. Technol., vol. 3, no. 5, pp. 1022-1030, 2009.
39. E. Dassau, B. W. Bequette, B. A. Buckingham, and F. J. Doyle III, "Detection of a meal using continuous glucose monitoring: implications for an artificial beta-cell, " Diabetes Care, vol. 31, no. 2, pp. 295-300, 2008.
40. R. Hovorka, V. Canonico, L. J. Chassin, U. Haueter, M. Massi-Benedetti, M. OrsiniFederici, T. R. Pieber, H. C. Schaller, L. Schaupp, T. Vering, and M. E. Wilinksa, "Nonlinear model predictive control of glucose concentration in subjects with type 1 diabetes, " Physiol. Meas., vol. 25, no. 4, pp. 905-20, Aug. 2004.
41. S. D. Patek, W. Bequette, M. Breton, B. A. Buckingham, E. Dassau, F. J. Doyle III, J. Lum, L. Magni, and H. Zisser, "In silico preclinical trials: Methodology and engineering guide to closed-loop control in type 1 diabetes meillitus, " J. Diabetes Sci. Technol., vol. 3, no. 2, pp. 269-281, 2009.
42. B. P. Kovatchev, M. B. Breton, C. D. Man, and C. Cobelli, "In silico preclinical trials: A proof of concept in closed-loop control of type 1 diabetes, " J. Diabetes Sci. Technol., vol. 3, no. 1, pp. 44-55, 2009.
43. American Diabetes Association, "Executive summary: Standards of medical care in diabetes-2013, " Diabetes Care, vol. 36, suppl. 1, pp. S4-S10, 2013.
44. L. Magni, D. M. Raimondo, C. D. Man, M. Breton, S. Patek, G. D. Nicolao, and C. Cobelli, "Evaluating the efficacy of closed-loop glucose regulation via control-variability analysis, " J. Diabetes Sci. Technol., vol. 2, no. 4, pp. 630-635, 2008.
45. J. R. Castle and W. K. Ward, "Amperometric glucose sensors: Sources of error and potential benefit of redundancy, " J. Diabetes Sci. Technol., vol. 4, no. 1, pp. 221-225, Jan. 2010.
46. H. Lee and B. W. Bequette, "A closed-loop artificial pancreas based on MPC: Human-friendly identification and automatic meal disturbance rejection, " in Proc. 17th IFAC World Congr., 2008, pp. 4252-4257.